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Active, not recruitingNCT03367702Updated Oct 29, 2026Results posted

Stereotactic Body Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Stage IIA-B Prostate Cancer

A Phase 3 interventional study of Intensity-Modulated Radiation Therapy and Quality-of-Life Assessment in Stage II Prostate Adenocarcinoma AJCC v7, sponsored by NRG Oncology. Active, not recruiting at 293 sites in 6 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by NRG Oncology · Phase 3, Interventional, and Treatment

Updated Oct 29, 2026Results postedStudy documents posted+5 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
698
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

This randomized phase III trial studies how well stereotactic body radiation therapy works compared to intensity-modulated radiation therapy in treating patients with stage IIA-B prostate cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Stereotactic body radiation therapy may work better in treating patients with prostate cancer.

Read the detailed description

PRIMARY OBJECTIVES:

I. To determine whether stereotactic body radiation therapy (SBRT) can be shown to be superior to hypofractionated intensity-modulated radiation therapy (IMRT) in terms of genitourinary (GU) and gastrointestinal (GI) toxicity by having fewer patients that experience a minimal important decline (MID) in urinary irritation/obstructive and bowel Health Related Quality of Life (HRQOL) as measured by Expanded Prostate Cancer Index Composite (EPIC)-26 at 24 months post completion of therapy.

II. To determine if SBRT (5 fractions of 7.25 Gy) is superior to hypofractionated IMRT (28 fractions of 2.5 Gy or 20 fractions of 3 Gy) as measured by disease free survival (DFS).

SECONDARY OBJECTIVES:

I. To determine whether SBRT can be shown to be superior to hypofractionated IMRT at 12 and 24 months post completion of therapy in terms of HRQOL by having fewer patients that experience a minimal important decline (MID) bowel (12 months only) sexual, hormonal, urinary irritation/obstructive (12 months only) and in urinary incontinence HRQOL as measured by EPIC-26.

II. To determine if SBRT (5 fractions of 7.25 Gy) is superior to hypofractionated IMRT (28 fractions of 2.5 Gy or 20 fractions of 3 Gy) as measured by biochemical failure, overall survival, local failure, prostate cancer specific survival, and distant metastases.

III. To determine the correspondence between the diagnostic magnetic resonance imaging (MRI) and biopsy.

IV. To determine if prostate imaging-reporting and data system (PIRADS)version (v)2.1 = 4/5 disease is prognostic for biochemical failure.

EXPLORATORY OBJECTIVES:

I. To determine whether a potentially more expensive therapy, SBRT, would be cost-effective than standard hypofractionated IMRT as measured by the European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L).

II. To determine if disease characteristics captured on baseline and follow-up MRI can be used to predict which patients will respond to SBRT versus hypofractionated IMRT.

III. To validate autosegmentation tools for the prostate and tumors. IV. Collect specimens for future translational research analyses.

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM I: Patients undergo IMRT once daily for 5 fractions per week for 20 or 28 fractions over less than 32 business days.

ARM II: Patients undergo SBRT at least every other day for 2-3 fractions per week over less than 17 business days.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

02

Conditions studied

  • Stage II Prostate Adenocarcinoma AJCC v7
03

In context

Lead sponsor

NRG Oncology is the lead sponsor of 72 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Previously untreated (no local therapy such as surgery, radiation cryotherapy, high-intensity focused ultrasound [HIFU], etc.) localized adenocarcinoma of the prostate with the following clinical findings:

    • Clinical stage by digital rectal exam of either T1c or T2a/b (limited to one side of the gland); (American Joint Committee on Cancer [AJCC], version 7) or cT1a-c or 2a or 2b
    • Stages T1a-T1b are eligible if patient underwent transurethral prostatic resection (TURP)

    • The patient must meet one of the following 3 criteria: 1) Gleason score must be Gleason 7(3+4) with a PSA \< 20 ng/mL, or 2) Gleason 6 (3+3) with a PSA > 10 ng/mL and \< 20 ng/mL which is considered intermediate risk and eligible for the study (AJCC, version 7), or 3) Group Grade 1 with a PSA > 10 ng/mL and \< 20 ng/mL or 2 with a PSA \< 20 ng/mL

      • If patient is receiving a 5-alpha reductase inhibitor at the time of enrollment, the baseline PSA value may be double the initial value and the medication should be discontinued but a is not required; to be eligible, a PSA drawn while still on the medicine must be:

        • \< 10 ng/mL if Gleason 7(3+4) (note this patient would be on stratification level 1 if PSA \< 5 ng/mL and stratification level 2 if less than 10 ng/mL)
        • > 5 ng/mL and less than 10 ng/mL for Gleason 6(3+3) (note this patient would be on stratification level 3)
    • The prostate volume must be \< 70 cc as reported at time of or by separate measure with ultrasound or other imaging modalities including magnetic resonance imaging (MRI) or computed tomography (CT) scan
    • Patients in active surveillance who elect to be treated are eligible if they meet protocol requirements
  • Age >= 18
  • History and physical including a digital rectal exam 60 days prior to registration
  • (ECOG) performance status 0-1 60 days prior to registration
  • MRI of the prostate and pelvis (per institutional standard of care [SOC] - should be compliant with PIRADSv2.1 guidelines) within 1 year prior to registration
  • Bone scan as clinically indicated within 120 days prior to registration
  • Charlson modified co-morbidity score =\< 4 for patients under 60 and =\< 5 for patients 60 and over 21 days prior to registration
  • International prostate symptom score (IPSS) of \< 15 21 days prior to registration
  • The patient must provide study-specific prior to study entry
  • Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire
  • Completion of all items of the EPIC-26 which will be data entered at registration 60 days prior to registration
  • Only English, Spanish, and French-speaking patients are eligible to participate as these are the only languages EPIC-26 has been validated in

Exclusion criteria

Exclusion Criteria:

  • Definitive clinical or radiologic evidence of disease; no nodal involvement or evidence of metastatic disease allowed as defined by screening of the pelvis
  • Definitive T3 disease on MRI

  • Prior or current invasive with current evidence of active disease within the past 2 years

    • Exceptions: Non-melanomatous skin cancer, carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; must be off treatment for at least 3 years
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • The use of hormonal therapy is not allowed; if the patient is on a 5-alpha reductase inhibitor, then they should be stopped prior to treatment once enrolled onto the study; no is required for this study to participate

  • Severe, active co-morbidity defined as follows:

    • (HIV) positive with \< 200 cells/microliter; Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; Note also that HIV testing is not required for eligibility for this protocol; this exclusion criterion is necessary because the treatments involved in this protocol may be significantly
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol; (patients on Coumadin or other blood thinning agents are eligible for this study)

  • to MRI

    • Cardiac pacemaker or defibrillator
    • Surgically implanted electrical devices such as spinal stimulation devices or intracranial stimulation devices, cochlear implants, the presence of metallic foreign bodies in the orbits, and incompatible old mechanical heart valves and aneurysm clips
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
698 participants (actual)

Study arms

  • Active comparator
    Arm I (IMRT)

    Patients undergo IMRT once daily for 5 fractions per week for 20 or 28 fractions over less than 32 business days.

    Radiation: Intensity-Modulated Radiation Therapy · Other: Quality-of-Life Assessment · Other: Questionnaire Administration

  • Experimental
    Arm II (SBRT)

    Patients undergo SBRT at least every other day for 2-3 fractions per week over less than 17 business days.

    Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Radiation: Stereotactic Body Radiation Therapy

Interventions

  • RadiationIntensity-Modulated Radiation Therapy

    Undergo IMRT

    Also known as: IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy

  • OtherQuality-of-Life Assessment

    Ancillary studies

    Also known as: Quality of Life Assessment

  • OtherQuestionnaire Administration

    Ancillary studies

  • RadiationStereotactic Body Radiation Therapy

    Undergo SBRT

    Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

06

What researchers measure

Primary outcomes

  1. Number of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at Two Years

    The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Time frame: Baseline and two years

  2. Number of Participants With a Decline of ≥5 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at Two Years

    The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Time frame: Baseline and two years

  3. Percentage of Participants Alive Without Disease (Disease-free Survival [DSF])

    Disease is defined as biochemical failure (Phoenix definition), local failure, regional failure, distant metastasis, or death from any cause. Disease-free survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.

    Time frame: Randomization to biochemical failure, local failure, regional failure, distant metastasis, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.

Secondary outcomes

  1. Percentage of Participants With Biochemical Failure

    Biochemical failure is defined as a rise in prostate-specific antigen (PSA) of ≥2.0 ng/mL above the post-treatment PSA nadir following radiation therapy for prostate cancer (Phoenix definition). Biochemical failure rates were estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis,

    Time frame: Randomization to biochemical failure, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.

  2. Percentage of Participants With Local Failure

    Local failure rates were estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis,

    Time frame: Randomization to local failure, death, or last known follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.

  3. Percentage of Participants With Regional Failure

    Regional failure rates were to be estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis, but for endpoints with ≤ 10 events overall, such as this one, only the count and raw percentage of participants with the event are provided.

    Time frame: From randomization to regional failure, death, or last known follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years.

  4. Percentage of Participants With Distant Metastasis

    Distant metastasis rates were to be estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis, but for endpoints with ≤ 10 events overall, such as this one, only the count and raw percentage of participants with the event are provided.

    Time frame: Randomization to distant metastasis, death, or last known follow-up date, whichever occurs first. Median follow-up time at time of analysis was 3.2 years.

  5. Percentage of Participants Who Died Due to Prostate Cancer

    Prostate cancer death rates were to be estimated using the cumulative incidence method, treating death due to other causes as a competing risk, and otherwise censoring participants alive at time of analysis, but for endpoints with ≤ 10 events overall, such as this one, only the count and raw percentage of participants with the event are provided.

    Time frame: Randomization to death or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years.

  6. Percentage of Particpants Alive (Overall Survival)

    Survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.

    Time frame: Randomization to death or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.

  7. Number of Participants With a Grade 3 or Higher Adverse Event

    Common Terminology Criteria for Adverse Events (version 5.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Adverse events reported as possibly, probably, or definitely related to treatment are considered to be treatment-related adverse events. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

    Time frame: Randomization to death or last follow-up. Median follow-up at time of analysis was 3.2 years.

  8. Number of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at One Year

    The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Time frame: Baseline and one year

  9. Number of Participants With a Decline of ≥4 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at One Year

    The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Time frame: Baseline and one year

  10. Number of Participants With a Decline of ≥6 Points in the EPIC-26 Urinary Incontinence Domain (Minimal Clinically Important Difference) at One Year

    The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Time frame: Baseline and one year

  11. Number of Participants With a Decline of ≥6 Points in the EPIC-26 Urinary Incontinence Domain (Minimal Clinically Important Difference) at Two Years

    The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Time frame: Baseline and two years

  12. Number of Participants With a Decline of ≥4 Points in the EPIC-26 Hormonal Domain (Minimal Clinically Important Difference) at One Year

    The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Time frame: Baseline and one year

  13. Number of Participants With a Decline of ≥4 Points in the EPIC-26 Hormonal Domain (Minimal Clinically Important Difference) at Two Years

    The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Time frame: Baseline and two years

  14. Number of Participants With a Decline of ≥10 Points in the EPIC-26 Sexual Domain (Minimal Clinically Important Difference) at One Year

    The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Time frame: Baseline and one year

  15. Number of Participants With a Decline of ≥10 Points in the EPIC-26 Sexual Domain (Minimal Clinically Important Difference) at Two Years

    The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Time frame: Baseline and two years

  16. Presence of Prostate Imaging-Reporting and Data System Version (PIRADSv) 2 = 4/5 Disease

    Will be assessed by magnetic resonance imaging (MRI).

    Time frame: Baseline

  17. Predictive Value of PIRADSv2 = 4/5 Disease for Biochemical Failure

    Predictive value of PIRADSv2 = 4/5 disease for biochemical failure

    Time frame: Up to 2 years

Other outcomes

  1. Number of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at Two Years by Ethnicity

    NIH-required analysis. The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Time frame: Baseline and two years

  2. Number of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at Two Years by Race

    NIH-required analysis. The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Time frame: Baseline and two years

  3. Number of Participants With a Decline of ≥5 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at Two Years by Ethnicity

    NIH-required analysis. The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Time frame: Baseline and two years

  4. Number of Participants With a Decline of ≥5 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at Two Years by Race

    NIH-required analysis. The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

    Time frame: Baseline and two years

  5. Percentage of Participants Alive Without Disease (Disease Free Survival) by Ethnicity.

    NIH-required analysis. Disease is defined as biochemical failure (Phoenix definition), local failure, regional failure, distant metastasis, or death from any cause. Disease-free survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.

    Time frame: Randomization to biochemical failure, local failure, regional failure, distant metastasis, death from any cause, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.

  6. Percentage of Participants Alive Without Disease (Disease Free Survival) by Race

    NIH-required analysis. Disease is defined as biochemical failure (Phoenix definition), local failure, regional failure, distant metastasis, or death from any cause. Disease-free survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.

    Time frame: Randomization to biochemical failure, local failure, regional failure, distant metastasis, death from any cause, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.

  7. Central Manual User Segmentation of Tumors

    Central manual user segmentation of tumors

    Time frame: Up to 2 years

  8. Performance of Supervised Automated Tumor Detection Toolset

    Performance of supervised automated tumor detection toolset

    Time frame: Up to 2 years

  9. Performance of Supervised Automated Tumor Segmentation Toolset

    Performance of supervised automated tumor segmentation toolset

    Time frame: Up to 5 years

  10. Image Registration Performance

    Image registration performance

    Time frame: Up to 2 years

  11. Predictive Utility of Radiomic Analysis

    Predictive utility of radiomic analysis

    Time frame: Up to 2 years

  12. Predictive Value for Local Control and Biochemical Failure

    Will be assessed by MRI.

    Time frame: At 2 years

07

Results

Posted Oct 29, 2026
Limitations and caveats
This study has two health-related quality of life (HRQOL) primary endpoints and an efficacy primary endpoint. The HRQOL results were reported as planned after the required two-year follow-up. The data monitoring committee determined that efficacy results should be released early after a planned interim futility analysis.

Participant flow

Participant flow — Overall Study
MilestoneArm I (IMRT)Arm II (SBRT)
Started345353
Eligible345351
Completed345353
Not completed00

Outcome measures

PrimaryNumber of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at Two Years

The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

Time frame:
Baseline and two years
Reported as:
Count of participants · Participants
Number of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at Two Years
ParticipantsArm I (IMRT)Arm II (SBRT)
Number of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at Two Years113101
Statistical analysis
  • Arm I (IMRT) vs Arm II (SBRT) · Chi-squared · p = 0.0342 (Two-sided significance level = 0.05.)
PrimaryNumber of Participants With a Decline of ≥5 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at Two Years

The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

Time frame:
Baseline and two years
Reported as:
Count of participants · Participants
Number of Participants With a Decline of ≥5 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at Two Years
ParticipantsArm I (IMRT)Arm II (SBRT)
Number of Participants With a Decline of ≥5 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at Two Years85102
Statistical analysis
  • Arm I (IMRT) vs Arm II (SBRT) · Chi-squared · p = 0.6811 (Two-sided significance level = 0.05.)
SecondaryPercentage of Participants With Biochemical Failure

Biochemical failure is defined as a rise in prostate-specific antigen (PSA) of ≥2.0 ng/mL above the post-treatment PSA nadir following radiation therapy for prostate cancer (Phoenix definition). Biochemical failure rates were estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis,

Time frame:
Randomization to biochemical failure, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.
Reported as:
Number · Percentage of participants
Percentage of Participants With Biochemical Failure
Percentage of participantsArm I (IMRT)Arm II (SBRT)
Percentage of Participants With Biochemical Failure1.9 (0.8 to 3.8)6.3 (4.1 to 9.2)
Statistical analysis
  • Arm I (IMRT) vs Arm II (SBRT) · Gray's test · p = 0.0367 (Two-sided significance level = 0.05.) · Hazard ratio (hr): 1.82 · 95% CI 1.03 to 3.33
SecondaryPercentage of Participants With Local Failure

Local failure rates were estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis,

Time frame:
Randomization to local failure, death, or last known follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.
Reported as:
Number · Percentage of participants
Percentage of Participants With Local Failure
Percentage of participantsArm I (IMRT)Arm II (SBRT)
Percentage of Participants With Local Failure0.6 (0.1 to 2.1)0.6 (0.1 to 1.9)
Statistical analysis
  • Arm I (IMRT) vs Arm II (SBRT) · Gray's test · p = 0.9697
SecondaryPercentage of Participants With Regional Failure

Regional failure rates were to be estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis, but for endpoints with ≤ 10 events overall, such as this one, only the count and raw percentage of participants with the event are provided.

Time frame:
From randomization to regional failure, death, or last known follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years.
Reported as:
Count of participants · Participants
Percentage of Participants With Regional Failure
ParticipantsArm I (IMRT)Arm II (SBRT)
Percentage of Participants With Regional Failure24
SecondaryPercentage of Participants With Distant Metastasis

Distant metastasis rates were to be estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive at time of analysis, but for endpoints with ≤ 10 events overall, such as this one, only the count and raw percentage of participants with the event are provided.

Time frame:
Randomization to distant metastasis, death, or last known follow-up date, whichever occurs first. Median follow-up time at time of analysis was 3.2 years.
Reported as:
Count of participants · Participants
Percentage of Participants With Distant Metastasis
ParticipantsArm I (IMRT)Arm II (SBRT)
Percentage of Participants With Distant Metastasis44
SecondaryPercentage of Participants Who Died Due to Prostate Cancer

Prostate cancer death rates were to be estimated using the cumulative incidence method, treating death due to other causes as a competing risk, and otherwise censoring participants alive at time of analysis, but for endpoints with ≤ 10 events overall, such as this one, only the count and raw percentage of participants with the event are provided.

Time frame:
Randomization to death or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years.
Reported as:
Count of participants · Participants
Percentage of Participants Who Died Due to Prostate Cancer
ParticipantsArm I (IMRT)Arm II (SBRT)
Percentage of Participants Who Died Due to Prostate Cancer00
SecondaryPercentage of Particpants Alive (Overall Survival)

Survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.

Time frame:
Randomization to death or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.
Reported as:
Number · Percentage of participants
Percentage of Particpants Alive (Overall Survival)
Percentage of participantsArm I (IMRT)Arm II (SBRT)
Percentage of Particpants Alive (Overall Survival)97.8 (95.5 to 99.0)98.6 (96.6 to 99.4)
Statistical analysis
  • Arm I (IMRT) vs Arm II (SBRT) · Log Rank · p = 0.6550 (Two-sided significance level = 0.05.) · Hazard ratio (hr): 1.21 · 95% CI 0.54 to 2.33Reference level = IMRT
SecondaryNumber of Participants With a Grade 3 or Higher Adverse Event

Common Terminology Criteria for Adverse Events (version 5.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Adverse events reported as possibly, probably, or definitely related to treatment are considered to be treatment-related adverse events. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

Time frame:
Randomization to death or last follow-up. Median follow-up at time of analysis was 3.2 years.
Reported as:
Count of participants · Participants
Number of Participants With a Grade 3 or Higher Adverse Event
ParticipantsArm I (IMRT)Arm II (SBRT)
Number of Participants With a Grade 3 or Higher Adverse Event5750
Statistical analysis
  • Arm I (IMRT) vs Arm II (SBRT) · Chi-squared · p = 0.2212 (Two-sided significance level = 0.05.)
SecondaryNumber of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at One Year

The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

Time frame:
Baseline and one year
Reported as:
Count of participants · Participants
Number of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at One Year
ParticipantsArm I (IMRT)Arm II (SBRT)
Number of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at One Year11798
Statistical analysis
  • Arm I (IMRT) vs Arm II (SBRT) · Chi-squared · p = 0.0022 (Two-sided significance level = 0.05.)
SecondaryNumber of Participants With a Decline of ≥4 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at One Year

The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

Time frame:
Baseline and one year
Reported as:
Count of participants · Participants
Number of Participants With a Decline of ≥4 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at One Year
ParticipantsArm I (IMRT)Arm II (SBRT)
Number of Participants With a Decline of ≥4 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at One Year94105
Statistical analysis
  • Arm I (IMRT) vs Arm II (SBRT) · Chi-squared · p = 0.7687 (Two-sided significance level = 0.05.)
Other pre-specifiedNumber of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at Two Years by Ethnicity

NIH-required analysis. The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

Time frame:
Baseline and two years
Reported as:
Count of participants · Participants
Number of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at Two Years by Ethnicity
ParticipantsArm I (IMRT)Arm II (SBRT)
Hispanic or Latino — Hispanic or Latino30
Not Hispanic or Latino — Hispanic or Latino10797
Unknown or Not Reported — Hispanic or Latino34
Other pre-specifiedNumber of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at Two Years by Race

NIH-required analysis. The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

Time frame:
Baseline and two years
Reported as:
Count of participants · Participants
Number of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at Two Years by Race
ParticipantsArm I (IMRT)Arm II (SBRT)
Asian11
Black or African American911
White9885
More than one race00
Unknown or Not Reported54
Other pre-specifiedNumber of Participants With a Decline of ≥5 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at Two Years by Ethnicity

NIH-required analysis. The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

Time frame:
Baseline and two years
Reported as:
Count of participants · Participants
Number of Participants With a Decline of ≥5 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at Two Years by Ethnicity
ParticipantsArm I (IMRT)Arm II (SBRT)
Hispanic or Latino31
Not Hispanic or Latino8198
Unknown or Not Reported13
Other pre-specifiedNumber of Participants With a Decline of ≥5 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at Two Years by Race

NIH-required analysis. The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

Time frame:
Baseline and two years
Reported as:
Count of participants · Participants
Number of Participants With a Decline of ≥5 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at Two Years by Race
ParticipantsArm I (IMRT)Arm II (SBRT)
Asian15
Black or African American1316
White6676
More than one race10
Unknown or Not Reported45
Other pre-specifiedPercentage of Participants Alive Without Disease (Disease Free Survival) by Ethnicity.

NIH-required analysis. Disease is defined as biochemical failure (Phoenix definition), local failure, regional failure, distant metastasis, or death from any cause. Disease-free survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.

Time frame:
Randomization to biochemical failure, local failure, regional failure, distant metastasis, death from any cause, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.
Reported as:
Number · Percentage of participants
Percentage of Participants Alive Without Disease (Disease Free Survival) by Ethnicity.
Percentage of participantsArm I (IMRT)Arm II (SBRT)
Hispanic or Latino100 (100 to 100)83.3 (27.3 to 97.5)
Not Hispanic or Latino95.7 (92.6 to 97.5)91.2 (87.6 to 93.8)
Unknown or Not Reported100 (100 to 100)100 (100 to 100)
Other pre-specifiedPercentage of Participants Alive Without Disease (Disease Free Survival) by Race

NIH-required analysis. Disease is defined as biochemical failure (Phoenix definition), local failure, regional failure, distant metastasis, or death from any cause. Disease-free survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.

Time frame:
Randomization to biochemical failure, local failure, regional failure, distant metastasis, death from any cause, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.
Reported as:
Number · Percentage of participants
Percentage of Participants Alive Without Disease (Disease Free Survival) by Race
Percentage of participantsArm I (IMRT)Arm II (SBRT)
Asian80.0 (40.9 to 94.6)90.0 (47.3 to 98.5)
Black or African American93.1 (80.0 to 97.7)95.3 (82.7 to 98.8)
White96.9 (93.9 to 98.4)91.4 (87.4 to 94.1)
More than one race100 (100 to 100)—
Unknown or Not Reported100 (100 to 100)82.4 (54.7 to 93.9)
American Indian or Alaskan Native—100 (100 to 100)
PrimaryPercentage of Participants Alive Without Disease (Disease-free Survival [DSF])

Disease is defined as biochemical failure (Phoenix definition), local failure, regional failure, distant metastasis, or death from any cause. Disease-free survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.

Time frame:
Randomization to biochemical failure, local failure, regional failure, distant metastasis, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.
Reported as:
Number · Percentage of participants
Percentage of Participants Alive Without Disease (Disease-free Survival [DSF])
Percentage of participantsArm I (IMRT)Arm II (SBRT)
Percentage of Participants Alive Without Disease (Disease-free Survival [DSF])95.9 (93.8 to 98.1)91.4 (88.4 to 94.3)
Statistical analysis
  • Arm I (IMRT) vs Arm II (SBRT) · Log Rank · p = 0.1325 (Two-sided significance level = 0.05.) · Hazard ratio (hr): 1.38 · 95% CI 0.91 to 2.09Reference level = IMRT
SecondaryNumber of Participants With a Decline of ≥6 Points in the EPIC-26 Urinary Incontinence Domain (Minimal Clinically Important Difference) at One Year

The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

Time frame:
Baseline and one year
Reported as:
Count of participants · Participants
Number of Participants With a Decline of ≥6 Points in the EPIC-26 Urinary Incontinence Domain (Minimal Clinically Important Difference) at One Year
ParticipantsArm I (IMRT)Arm II (SBRT)
Number of Participants With a Decline of ≥6 Points in the EPIC-26 Urinary Incontinence Domain (Minimal Clinically Important Difference) at One Year8780
Statistical analysis
  • Arm I (IMRT) vs Arm II (SBRT) · Chi-squared · p = 0.0541 (Two-sided significance level = 0.05.)
SecondaryNumber of Participants With a Decline of ≥6 Points in the EPIC-26 Urinary Incontinence Domain (Minimal Clinically Important Difference) at Two Years

The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

Time frame:
Baseline and two years
Reported as:
Count of participants · Participants
Number of Participants With a Decline of ≥6 Points in the EPIC-26 Urinary Incontinence Domain (Minimal Clinically Important Difference) at Two Years
ParticipantsArm I (IMRT)Arm II (SBRT)
Number of Participants With a Decline of ≥6 Points in the EPIC-26 Urinary Incontinence Domain (Minimal Clinically Important Difference) at Two Years9075
Statistical analysis
  • Arm II (SBRT) · Chi-squared · p = 0.0234 (Two-sided significance level = 0.05.)
SecondaryNumber of Participants With a Decline of ≥4 Points in the EPIC-26 Hormonal Domain (Minimal Clinically Important Difference) at One Year

The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

Time frame:
Baseline and one year
Reported as:
Count of participants · Participants
Number of Participants With a Decline of ≥4 Points in the EPIC-26 Hormonal Domain (Minimal Clinically Important Difference) at One Year
ParticipantsArm I (IMRT)Arm II (SBRT)
Number of Participants With a Decline of ≥4 Points in the EPIC-26 Hormonal Domain (Minimal Clinically Important Difference) at One Year8273
Statistical analysis
  • Arm I (IMRT) vs Arm II (SBRT) · Chi-squared · p = 0.0900 (Two-sided significance level = 0.05.)
SecondaryNumber of Participants With a Decline of ≥4 Points in the EPIC-26 Hormonal Domain (Minimal Clinically Important Difference) at Two Years

The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

Time frame:
Baseline and two years
Reported as:
Count of participants · Participants
Number of Participants With a Decline of ≥4 Points in the EPIC-26 Hormonal Domain (Minimal Clinically Important Difference) at Two Years
ParticipantsArm I (IMRT)Arm II (SBRT)
Number of Participants With a Decline of ≥4 Points in the EPIC-26 Hormonal Domain (Minimal Clinically Important Difference) at Two Years8284
Statistical analysis
  • Arm I (IMRT) vs Arm II (SBRT) · Chi-squared · p = 0.6507 (Two-sided significance level = 0.05.)
SecondaryNumber of Participants With a Decline of ≥10 Points in the EPIC-26 Sexual Domain (Minimal Clinically Important Difference) at One Year

The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

Time frame:
Baseline and one year
Reported as:
Count of participants · Participants
Number of Participants With a Decline of ≥10 Points in the EPIC-26 Sexual Domain (Minimal Clinically Important Difference) at One Year
ParticipantsArm I (IMRT)Arm II (SBRT)
Number of Participants With a Decline of ≥10 Points in the EPIC-26 Sexual Domain (Minimal Clinically Important Difference) at One Year10794
Statistical analysis
  • Arm I (IMRT) vs Arm II (SBRT) · Chi-squared · p = 0.0260 (Two-sided significance level = 0.05.)
SecondaryNumber of Participants With a Decline of ≥10 Points in the EPIC-26 Sexual Domain (Minimal Clinically Important Difference) at Two Years

The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.

Time frame:
Baseline and two years
Reported as:
Count of participants · Participants
Number of Participants With a Decline of ≥10 Points in the EPIC-26 Sexual Domain (Minimal Clinically Important Difference) at Two Years
ParticipantsArm I (IMRT)Arm II (SBRT)
Number of Participants With a Decline of ≥10 Points in the EPIC-26 Sexual Domain (Minimal Clinically Important Difference) at Two Years102116
Statistical analysis
  • Arm I (IMRT) vs Arm II (SBRT) · Chi-squared · p = 0.6728
SecondaryPresence of Prostate Imaging-Reporting and Data System Version (PIRADSv) 2 = 4/5 Disease

Will be assessed by magnetic resonance imaging (MRI).

Time frame:
Baseline

Results for this outcome have not been posted.

SecondaryPredictive Value of PIRADSv2 = 4/5 Disease for Biochemical Failure

Predictive value of PIRADSv2 = 4/5 disease for biochemical failure

Time frame:
Up to 2 years

Results for this outcome have not been posted.

Other pre-specifiedCentral Manual User Segmentation of Tumors

Central manual user segmentation of tumors

Time frame:
Up to 2 years

Results for this outcome have not been posted.

Other pre-specifiedPerformance of Supervised Automated Tumor Detection Toolset

Performance of supervised automated tumor detection toolset

Time frame:
Up to 2 years

Results for this outcome have not been posted.

Other pre-specifiedPerformance of Supervised Automated Tumor Segmentation Toolset

Performance of supervised automated tumor segmentation toolset

Time frame:
Up to 5 years

Results for this outcome have not been posted.

Other pre-specifiedImage Registration Performance

Image registration performance

Time frame:
Up to 2 years

Results for this outcome have not been posted.

Other pre-specifiedPredictive Utility of Radiomic Analysis

Predictive utility of radiomic analysis

Time frame:
Up to 2 years

Results for this outcome have not been posted.

Other pre-specifiedPredictive Value for Local Control and Biochemical Failure

Will be assessed by MRI.

Time frame:
At 2 years

Results for this outcome have not been posted.

Adverse events

Collected over Randomization to death or last follow-up. Median follow-up at time of analysis was 3.2 years.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm I (IMRT)13/345 (3.8%)12/323 (3.7%)300/323 (92.9%)
Arm II (SBRT)16/353 (4.5%)3/352 (0.9%)315/352 (89.5%)
Most frequent serious events
Showing 10 of 25
Most frequent serious events
EventArm I (IMRT)Arm II (SBRT)
AnemiaBlood and lymphatic system disorders2/3230/352
Chest pain - cardiacCardiac disorders2/3230/352
Rectal hemorrhageGastrointestinal disorders2/3230/352
HematuriaRenal and urinary disorders2/3230/352
Colonic fistulaGastrointestinal disorders1/3230/352
Colonic obstructionGastrointestinal disorders1/3230/352
Colonic perforationGastrointestinal disorders1/3230/352
Fecal incontinenceGastrointestinal disorders1/3230/352
GastritisGastrointestinal disorders1/3230/352
ProctitisGastrointestinal disorders1/3230/352
Most frequent other events
Showing 10 of 23
Most frequent other events
EventArm I (IMRT)Arm II (SBRT)
Urinary frequencyRenal and urinary disorders219/323200/352
FatigueGeneral disorders and administration site conditions164/323138/352
Urinary urgencyRenal and urinary disorders151/323141/352
Renal and urinary disorders - OtherRenal and urinary disorders118/323106/352
DysuriaRenal and urinary disorders115/323101/352
Erectile dysfunctionReproductive system and breast disorders104/323119/352
DiarrheaGastrointestinal disorders92/32368/352
Urinary retentionRenal and urinary disorders67/32365/352
Urinary incontinenceRenal and urinary disorders66/32361/352
Rectal hemorrhageGastrointestinal disorders56/32337/352

Baseline characteristics

Randomized participants

Age, Continuous
Age, Continuous(years)Arm I (IMRT)Arm II (SBRT)Total
Median68 (42 to 83)69 (45 to 84)68 (42 to 84)
Sex: Female, Male
Sex: Female, Male(Participants)Arm I (IMRT)Arm II (SBRT)Total
Female000
Male345353698
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm I (IMRT)Arm II (SBRT)Total
American Indian or Alaska Native011
Asian101020
Native Hawaiian or Other Pacific Islander000
Black or African American474390
White276282558
More than one race202
Unknown or Not Reported101727
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm I (IMRT)Arm II (SBRT)Total
Hispanic or Latino13619
Not Hispanic or Latino322335657
Unknown or Not Reported101222
Risk group
Risk group(Participants)Arm I (IMRT)Arm II (SBRT)Total
Gleason score 7 (3+4) with PSA < 10 ng/ml257256513
Gleason score 7 (3+4) with 10 ng/mL ≤ PSA < 20 ng/mL7274146
Gleason score 6 (3+3) with 10 ng/mL ≤ PSA < 20 ng/mL162339
Baseline PSA
Baseline PSA(ng/mL)Arm I (IMRT)Arm II (SBRT)Total
Median7.1 (1.6 to 19.7)7.0 (0.4 to 19.4)7.05 (0.4 to 19.7)
T-Stage
T-Stage(Participants)Arm I (IMRT)Arm II (SBRT)Total
T1285285570
T26068128
N-Stage
N-Stage(Participants)Arm I (IMRT)Arm II (SBRT)Total
N0345353698
Other000

5 further baseline measures are reported on the registry.

08

Study locations

293 sites

Showing the first 100 of 293 sites across 6 countries. Choose a country and city above to see the rest.

09

References and documents

Publications

  • Ellis RJ, Pugh SL, Yu JB, Feng FY, Konski AA, Grubb RL 3rd, Wallace RE, Gladstone DJ, Menard C, Miccio JA, Frazier AJ, Pennington JD, Michalski JM, Spratt DE, Martinez A, Morgan SC, Mihai A, Solanki AA, Amjad A, Straza MW, Delouya G, Schroeder TM, Marshall DT, Kapadia N, Patel AN, Cescon TP, El-Gayed A, Yoon HA, Paulus R, Sandler HM; NRG-GU005 Collaborative Authors. Stereotactic Body Radiotherapy vs Moderately Hypofractionated IMRT for Localized Intermediate-Risk Prostate Cancer: A Randomized Clinical Trial. JAMA. 2026 Aug 13:e2612627. doi: 10.1001/jama.2026.12627. Online ahead of print. PubMed 42593775 ↗
  • Alley S, Tonneau M, Olivie D, Tempany-Afdhal CM, Choyke PL, Turkbey IB, van der Heide UA, Ellis RJ, Kadoury S, Boike TP, Pennington JD, Frazier A, Lawton CAF, Leong N, Mihai AM, Morgan SC, Solanki AA, Michalski JM, Feng FY, Sandler HM, Menard C. Assessing Quality and Adherence to PI-RADSv2.1 Minimum Technical Standards of Prostate MRI in NRG-GU005. J Magn Reson Imaging. 2026 Feb;63(2):464-474. doi: 10.1002/jmri.70142. Epub 2025 Oct 8. PubMed 41063518 ↗
  • Alley S, Jackson E, Olivie D, Van der Heide UA, Menard C, Kadoury S. Effect of magnetic resonance imaging pre-processing on the performance of model-based prostate tumor probability mapping. Phys Med Biol. 2022 Dec 13;67(24). doi: 10.1088/1361-6560/ac99b4. PubMed 36223780 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Data sharing details ↗ · grants.nih.gov

10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Feb 2018 to primary completion in Jan 2025, 83 months.

Results were first posted in Oct 2026, 1 year 9 months after primary completion.

Primary completion moved once since we started tracking on Sep 25, 2026: Dec 2027 → Jan 2025, on Oct 29, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Dec 5, 2017
First posted
Dec 11, 2017
StartActual
Feb 1, 2018
Primary completionActual
Jan 15, 2025was Dec 2027
CompletionEst.
Dec 1, 2027
Results first posted
Oct 29, 2026
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Results
Results posted
posted Oct 29, 2026
Sites
2 sites added, 2 sites removed
Show 2 added (2 United States)
  • Sands Cancer Center · Canandiaqua, United States
  • Covenant Health Cancer Centers · Knoxville, United States
Show 2 removed
  • Sands Cancer Center · Canandaigua, United States
  • Thompson Cancer Survival Center · Knoxville, United States
Oct 29, 2026
Primary completion
Dec 1, 2027→Jan 15, 2025 (actual)
Oct 29, 2026
Enrollment
692 (estimated)→698 (actual)
Oct 29, 2026
Primary outcomes
3 added, 2 removed
What changed in the outcomes
  • AddedNumber of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at Two YearsTime frame: Baseline and two years
  • AddedNumber of Participants With a Decline of ≥5 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at Two YearsTime frame: Baseline and two years
  • AddedPercentage of Participants Alive Without Disease (Disease-free Survival [DSF])Time frame: Randomization to biochemical failure, local failure, regional failure, distant metastasis, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.
  • RemovedIncidence of patients-reported gastrointestinal and genitourinary toxicityTime frame: Up to 2 years
  • RemovedDisease free survivalTime frame: Time to biochemical failure (Phoenix definition), local failure, regional failure, distant metastasis, or death from any cause, assessed up to 2 years
Oct 29, 2026
Documents
Oct 29, 2026
Publications
1 publication citing this study linked from PubMed, e.g. PubMed 42593775 ↗
Oct 29, 2026
Secondary outcomes
12 edited, 14 added, 4 removed, 3 more
What changed in the outcomes
  • EditedPercentage of Participants With Biochemical failureFailureTime frame: Up to 2 years → Randomization to biochemical failure, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.
  • EditedPercentage of Participants With Local failureFailureTime frame: From the time of randomization to the date of local failure, date of precluding death, or last known follow-up date, assessed for up to 2 years → Randomization to local failure, death, or last known follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.
  • EditedPercentage of Participants With Regional failureFailureTime frame: From the time of randomization to the date of local failure, date of precluding death, or last known follow-up date, assessed for up to 2 years → From randomization to regional failure, death, or last known follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years.
  • EditedPercentage of Participants With Distant metastasisMetastasisTime frame: From the time of randomization to the date of distant metastasis, date of precluding death, or last known follow-up date, assessed for up to 2 years → Randomization to distant metastasis, death, or last known follow-up date, whichever occurs first. Median follow-up time at time of analysis was 3.2 years.
  • EditedPresence of Prostate Imaging-Reporting and Data System versionVersion (PIRADSv) 2 = 4/5 diseaseDiseaseTime frame: Baseline
  • EditedPredictive valueValue of PIRADSv2 = 4/5 diseaseDisease for biochemical failureBiochemical FailureTime frame: Up to 2 years
  • AddedPercentage of Participants Who Died Due to Prostate CancerTime frame: Randomization to death or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years.
  • AddedPercentage of Particpants Alive (Overall Survival)Time frame: Randomization to death or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.
  • AddedNumber of Participants With a Grade 3 or Higher Adverse EventTime frame: Randomization to death or last follow-up. Median follow-up at time of analysis was 3.2 years.
  • AddedNumber of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at One YearTime frame: Baseline and one year
  • AddedNumber of Participants With a Decline of ≥4 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at One YearTime frame: Baseline and one year
  • AddedNumber of Participants With a Decline of ≥6 Points in the EPIC-26 Urinary Incontinence Domain (Minimal Clinically Important Difference) at One YearTime frame: Baseline and one year
  • AddedNumber of Participants With a Decline of ≥6 Points in the EPIC-26 Urinary Incontinence Domain (Minimal Clinically Important Difference) at Two YearsTime frame: Baseline and two years
  • AddedNumber of Participants With a Decline of ≥4 Points in the EPIC-26 Hormonal Domain (Minimal Clinically Important Difference) at One YearTime frame: Baseline and one year
  • AddedNumber of Participants With a Decline of ≥4 Points in the EPIC-26 Hormonal Domain (Minimal Clinically Important Difference) at Two YearsTime frame: Baseline and two years
  • AddedNumber of Participants With a Decline of ≥10 Points in the EPIC-26 Sexual Domain (Minimal Clinically Important Difference) at One YearTime frame: Baseline and one year
  • AddedNumber of Participants With a Decline of ≥10 Points in the EPIC-26 Sexual Domain (Minimal Clinically Important Difference) at Two YearsTime frame: Baseline and two years
  • RemovedHealth related quality of lifeTime frame: Up to 2 years
  • RemovedProstate cancer specific survivalTime frame: Up to 2 years
  • RemovedOverall survivalTime frame: From the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, assessed up to 5 years
  • RemovedIncidence of adverse events (AEs)Time frame: Up to 2 years
  • Editedother outcomeCentral manual user segmentationManual User Segmentation of tumorsTumorsTime frame: Up to 2 years
  • Editedother outcomePerformance of supervised automated tumor detection toolsetSupervised Automated Tumor Detection ToolsetTime frame: Up to 2 years
  • Editedother outcomePerformance of supervised automated tumor segmentation toolsetSupervised Automated Tumor Segmentation ToolsetTime frame: Up to 5 years
  • Editedother outcomeImage registration performanceRegistration PerformanceTime frame: Up to 2 years
  • Editedother outcomePredictive utilityUtility of radiomic analysisRadiomic AnalysisTime frame: Up to 2 years
  • Editedother outcomePredictive valueValue for local controlLocal Control and biochemical failureBiochemical FailureTime frame: At 2 years
  • Addedother outcomeNumber of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at Two Years by EthnicityTime frame: Baseline and two years
  • Addedother outcomeNumber of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at Two Years by RaceTime frame: Baseline and two years
  • Addedother outcomeNumber of Participants With a Decline of ≥5 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at Two Years by EthnicityTime frame: Baseline and two years
  • …and 3 more, on the record history on ClinicalTrials.gov ↗
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Results posted
    Documents Protocol and statistical analysis plan ↗ posted · Informed consent form ↗ posted
    Publications 1 publication citing this study linked from PubMed, e.g. PubMed 42593775 ↗
    2 sites added, 2 sites removed
    Show 2 added (2 United States)
    • Sands Cancer Center · Canandiaqua, United States
    • Covenant Health Cancer Centers · Knoxville, United States
    Show 2 removed
    • Sands Cancer Center · Canandaigua, United States
    • Thompson Cancer Survival Center · Knoxville, United States
    Primary completion Dec 1, 2027→Jan 15, 2025 (now actual)
    Enrollment 692 (estimated)→698 (actual)
    Primary outcomes 3 added, 2 removed
    What changed in the outcomes
    • AddedNumber of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at Two YearsTime frame: Baseline and two years
    • AddedNumber of Participants With a Decline of ≥5 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at Two YearsTime frame: Baseline and two years
    • AddedPercentage of Participants Alive Without Disease (Disease-free Survival [DSF])Time frame: Randomization to biochemical failure, local failure, regional failure, distant metastasis, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.
    • RemovedIncidence of patients-reported gastrointestinal and genitourinary toxicityTime frame: Up to 2 years
    • RemovedDisease free survivalTime frame: Time to biochemical failure (Phoenix definition), local failure, regional failure, distant metastasis, or death from any cause, assessed up to 2 years
    Secondary outcomes 12 edited, 14 added, 4 removed, 3 more
    What changed in the outcomes
    • EditedPercentage of Participants With Biochemical failureFailureTime frame: Up to 2 years → Randomization to biochemical failure, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.
    • EditedPercentage of Participants With Local failureFailureTime frame: From the time of randomization to the date of local failure, date of precluding death, or last known follow-up date, assessed for up to 2 years → Randomization to local failure, death, or last known follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.
    • EditedPercentage of Participants With Regional failureFailureTime frame: From the time of randomization to the date of local failure, date of precluding death, or last known follow-up date, assessed for up to 2 years → From randomization to regional failure, death, or last known follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years.
    • EditedPercentage of Participants With Distant metastasisMetastasisTime frame: From the time of randomization to the date of distant metastasis, date of precluding death, or last known follow-up date, assessed for up to 2 years → Randomization to distant metastasis, death, or last known follow-up date, whichever occurs first. Median follow-up time at time of analysis was 3.2 years.
    • EditedPresence of Prostate Imaging-Reporting and Data System versionVersion (PIRADSv) 2 = 4/5 diseaseDiseaseTime frame: Baseline
    • EditedPredictive valueValue of PIRADSv2 = 4/5 diseaseDisease for biochemical failureBiochemical FailureTime frame: Up to 2 years
    • AddedPercentage of Participants Who Died Due to Prostate CancerTime frame: Randomization to death or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years.
    • AddedPercentage of Particpants Alive (Overall Survival)Time frame: Randomization to death or last follow-up, whichever occurs first. Median follow-up at time of analysis was 3.2 years. Two-year estimates are reported.
    • AddedNumber of Participants With a Grade 3 or Higher Adverse EventTime frame: Randomization to death or last follow-up. Median follow-up at time of analysis was 3.2 years.
    • AddedNumber of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at One YearTime frame: Baseline and one year
    • AddedNumber of Participants With a Decline of ≥4 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at One YearTime frame: Baseline and one year
    • AddedNumber of Participants With a Decline of ≥6 Points in the EPIC-26 Urinary Incontinence Domain (Minimal Clinically Important Difference) at One YearTime frame: Baseline and one year
    • AddedNumber of Participants With a Decline of ≥6 Points in the EPIC-26 Urinary Incontinence Domain (Minimal Clinically Important Difference) at Two YearsTime frame: Baseline and two years
    • AddedNumber of Participants With a Decline of ≥4 Points in the EPIC-26 Hormonal Domain (Minimal Clinically Important Difference) at One YearTime frame: Baseline and one year
    • AddedNumber of Participants With a Decline of ≥4 Points in the EPIC-26 Hormonal Domain (Minimal Clinically Important Difference) at Two YearsTime frame: Baseline and two years
    • AddedNumber of Participants With a Decline of ≥10 Points in the EPIC-26 Sexual Domain (Minimal Clinically Important Difference) at One YearTime frame: Baseline and one year
    • AddedNumber of Participants With a Decline of ≥10 Points in the EPIC-26 Sexual Domain (Minimal Clinically Important Difference) at Two YearsTime frame: Baseline and two years
    • RemovedHealth related quality of lifeTime frame: Up to 2 years
    • RemovedProstate cancer specific survivalTime frame: Up to 2 years
    • RemovedOverall survivalTime frame: From the date of randomization to the date of death or last known follow-up date, with patients alive at the last known follow-up time treated as censored, assessed up to 5 years
    • RemovedIncidence of adverse events (AEs)Time frame: Up to 2 years
    • Editedother outcomeCentral manual user segmentationManual User Segmentation of tumorsTumorsTime frame: Up to 2 years
    • Editedother outcomePerformance of supervised automated tumor detection toolsetSupervised Automated Tumor Detection ToolsetTime frame: Up to 2 years
    • Editedother outcomePerformance of supervised automated tumor segmentation toolsetSupervised Automated Tumor Segmentation ToolsetTime frame: Up to 5 years
    • Editedother outcomeImage registration performanceRegistration PerformanceTime frame: Up to 2 years
    • Editedother outcomePredictive utilityUtility of radiomic analysisRadiomic AnalysisTime frame: Up to 2 years
    • Editedother outcomePredictive valueValue for local controlLocal Control and biochemical failureBiochemical FailureTime frame: At 2 years
    • Addedother outcomeNumber of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at Two Years by EthnicityTime frame: Baseline and two years
    • Addedother outcomeNumber of Participants With a Decline of ≥4 Points in the EPIC-26 Bowel Domain (Minimal Clinically Important Difference) at Two Years by RaceTime frame: Baseline and two years
    • Addedother outcomeNumber of Participants With a Decline of ≥5 Points in the EPIC-26 Urinary Irritation Domain (Minimal Clinically Important Difference) at Two Years by EthnicityTime frame: Baseline and two years
    • …and 3 more, on the record history on ClinicalTrials.gov ↗
    + 5 other changes: index terms, verification date, oversight details, data sharing statement and registry notes

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT03367702
Lead sponsor
NRG Oncology
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Dec 11, 2017
Start date
Feb 1, 2018
Primary completion
Jan 15, 2025
Completion
Dec 1, 2027 (estimated)
Results posted
Oct 29, 2026
Last update
Oct 29, 2026

Study contacts

Rodney J Ellis
principal investigator · NRG Oncology

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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