A Phase 3 interventional study of Brachytherapy (100/110) and Brachytherapy (125/145) in Prostate Cancer, sponsored by Radiation Therapy Oncology Group. Completed at 170 sites in 2 countries. Open to male participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by Radiation Therapy Oncology Group · Phase 3, Interventional, and Treatment
RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining interstitial brachytherapy with external-beam radiation therapy may kill more tumor cells. It is not yet known whether interstitial brachytherapy is more effective with or without external-beam radiation therapy in treating prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial brachytherapy with or without external-beam radiation therapy in treating patients who have prostate cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (T1c vs T2a or T2b), Gleason score (≤ 6 vs 7), prostate-specific antigen (\< 10 ng/mL vs 10-20 ng/mL), and prior neoadjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed at 3-5 weeks, at 4, 6, 9, and 12 months, every 6 months for 4 years, and then annually thereafter.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 588 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Radiation Therapy Oncology Group is the lead sponsor of 155 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
confirmed adenocarcinoma of the prostate
Intermediate-risk disease, as defined by 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Prior hormonal therapy allowed provided the following are true:
Radiotherapy
Surgery
Other
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
External beam radiation therapy (EBRT) and transperineal interstitial permanent brachytherapy (100/110)
Radiation: Brachytherapy (100/110) · Radiation: External Beam Radiation Therapy
Transperineal interstitial permanent brachytherapy (125/145)
Radiation: Brachytherapy (125/145)
100 Gy Palladium-103 (P-102) or 110 Gy Iodine-125 (I-125) seeds within 2-4 weeks of completion of external beam radiotherapy.
125 Gy Palladium-103 (P-103) or 145 Gy Iodine-125 (I-125) seeds within 4 weeks of study entry.
Total dose of 45 Gy to the prostate and seminal vesicles as a daily dose of 1.8 Gy given 5 times per week. The prescribed dose is defined at the International Commission of Radiation Units and Measurements (ICRU) reference point. Both 3D-conformal radiation therapy (3DCRT) and intensity modulated radiation therapy (IMRT) are permitted.
Also known as: EBRT
5-Year Freedom From Progression Rate
A Freedom from Progression (FFP) failure includes biochemical failure, local failure, distant failure, or death due to any cause. Patients who are failure free with less than 5 years of follow-up or who receive any secondary salvage therapy are censored. Freedom from Progression rates are estimated using the Kaplan-Meier method.
Time frame: From randomization to 5 years
Biochemical Failure Rate (Protocol Definition)
Biochemical failure is defined as having 3 consecutive rises of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before 3 consecutive elevations are documented. The sum of the 3 consecutive rises must exceed 1 ng/mL above the nadir. If 3 consecutive PSA rises occur during the first 24 months followed by a subsequent non-hormonal induced PSA decrease, patients will not be considered PSA failures. Three consecutive rises with any of the 3 PSA values occurring more than 24 months after the implant procedure will constitute a failure. Time to biochemical is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. Five year rates are reported.
Time frame: From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.
Biochemical Failure (Phoenix Definition)
Biochemical Failure is defined as an increase of 2 ng/ml or more in PSA over the nadir PSA after 24 months from the start of treatment or the start of salvage hormones. Time to biochemical is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. Five year rates are reported.
Time frame: From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.Maximum follow-up at time of analysis was 13.9 years.
Prostate Cancer Death
Prostate cancer death is defined as death due to prostate cancer or complications of treatment or death associated with any of the following: 1) further clinical tumor progression occurring after initiation of salvage androgen suppression therapy; 2) a rise that exceeds 1.0 ng/ml in the serum PSA level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy; and 3) disease progression in the absence of any anti-tumor therapy. Time to prostate cancer death is defined as time from randomization to the date of prostate cancer death, last known follow-up (censored), or death without prostate cancer (competing risk). Prostate cancer death rates are estimated using the cumulative incidence method. Five year rates are reported.
Time frame: From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.
Local Failure
Failure is defined as progression (increase in palpable abnormality) at any time, failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Histologic criteria for local failure are presence of prostatic carcinoma upon biopsy and positive biopsy of the palpably normal prostate more than two years after the start of treatment. Time to local failure is defined as time from randomization to the date of first local failure, last known follow-up (censored), or death without local failure (competing risk). Local failure rates are estimated using the cumulative incidence method. Five year rates are reported.
Time frame: From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.
Distant Metastases
Failure is defined as the appearance of any distant metastases. Time to distant metastases is defined as time from randomization to the date of first distant metastases, last known follow-up (censored), or death without distant metastases (competing risk). Distant metastases rates are estimated using the cumulative incidence method. Five year rates are reported.
Time frame: From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.
Overall Survival
Failure is defined as death due to any cause. Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Survival rates are estimated using the Kaplan-Meier method. Five year rates are reported.
Time frame: From randomization to last follow-up. Analysis occurs after all patients had been on study for at least 5 years. Maximum follow-up at time of analysis was 13.9 years.
Percentage of Patients With Acute Grade 2+ and Grade 3+ Toxicities [Genitourinary (GU), Gastrointestinal (GI), and Overall]
Acute toxicities are scored according to NCI Common Toxicity Criteria (CTC) version 2.0 and will be defined as the worst severity of the toxicity occurring ≤ 180 days from start of radiation. The CTC v 2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to based.
Time frame: Zero to 180 days from the start of radiation
Time to Late Grade 3+ Toxicities [Genitourinary (GU), Gastrointestinal (GI), and Overall]
Late toxicities are scored according to the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Scheme and will be defined as the worst severity of the toxicity occurring \> 180 days from radiation start. Grade 3+ GU/GI and overall were analyzed. RTOG/EORTC Late Radiation Morbidity Scoring Scheme assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. Time to late grade 3+ toxicity is defined as time from randomization to the date of first late grade 3+ toxicity, last known follow-up (censored), or death without late grade 3+ toxicity (competing risk). Late grade 3+ toxicity rates are estimated using the cumulative incidence method. Five year rates are reported.
Time frame: From 181 days after the start of radiation to last follow-up. Maximum follow-up at time of analysis was 13.9 years.
Change in Expanded Prostate Cancer Index Composite (EPIC) From Baseline to 4 Months
The EPIC form is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal function). The urinary domain summary score can be separated into 2 distinct subscales: urinary incontinence and urinary irritative. Hormonal domain was excluded as concurrent use of hormones was exclusionary and prior neoadjuvant hormone use was low. Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. The change score was calculated as the value at 4 months minus the value at baseline. A negative change reflects a decline at 4 months and a positive change reflects an improvement at 4 months.
Time frame: Baseline and 4 months after start of radiation
Change in Expanded Prostate Cancer Index Composite (EPIC) From Baseline to 24 Months
The EPIC form is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal function). The urinary domain summary score can be separated into 2 distinct subscales: urinary incontinence and urinary irritative. Hormonal domain was excluded as concurrent use of hormones was exclusionary and prior neoadjuvant hormone use was low. Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. The change score was calculated as the value at 24 months minus the value at baseline. A negative change reflects a decline at 24 months and a positive change reflects an improvement at 24 months.
Time frame: Baseline and 24 months after start of radiation
Change in Total American Urological Association Symptom Index (AUA-SI) Score From Baseline to 4 Months
The AUA-SI is a validated 7-item measure used to assess urinary symptoms. A higher score indicates more severe symptoms for the individual questions and overall total. Six questions ask about frequency of symptoms over the past month with possible responses: 0= Not at all; 1 = Less than 1 time in 5; 2 = less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. An additional question asks the number of times one gets up to urinate after going to bed, with response indicating the exact number of times ranging from 0 to 5. The total score is the sum of the questions and ranges from 0 to 35. Change is calculated as follow-up timepoint score - baseline score such that a negative change reflects an improvement at the follow-up timepoint and a positive change reflects a decline at the follow-up timepoint.
Time frame: Baseline and 4 months after start of radiation
Change in Total American Urological Association Symptom Index (AUA-SI) Score From Baseline to 24 Months
The AUA-SI is a validated 7-item measure used to assess urinary symptoms. A higher score indicates more severe symptoms for the individual questions and overall total. Six questions ask about frequency of symptoms over the past month with possible responses: 0= Not at all; 1 = Less than 1 time in 5; 2 = less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. An additional question asks the number of times one gets up to urinate after going to bed, with response indicating the exact number of times ranging from 0 to 5. The total score is the sum of the questions and ranges from 0 to 35. Change is calculated as follow-up timepoint score - baseline score such that a negative change reflects an improvement at the follow-up timepoint and a positive change reflects a decline at the follow-up timepoint.
Time frame: Baseline and 24 months after start of radiation
Change in European Quality of Life-5 Domains (EQ-5D) From Baseline to 4 Months
The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The change score was calculated as the value at the follow-up timepoint minus the value at baseline. A negative change reflects a decline at the follow-up timepoint and a positive change reflects an improvement at the follow-up timepoint.
Time frame: Baseline and 4 months after start of radiation
Change in European Quality of Life-5 Domains (EQ-5D) From Baseline to 24 Months
The EQ5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The change score was calculated as the value at the follow-up timepoint minus the value at baseline. A negative change reflects a decline at the follow-up timepoint and a positive change reflects an improvement at the follow-up timepoint.
Time frame: Baseline and 24 months after start of radiation
Feasibility of Collecting Medicare Data in a Large RTOG Prostate Cancer Clinical Trial for Cost Effectiveness and Cost Utility Analysis of Combined Treatment With Interstitial Brachytherapy and External Beam Radiotherapy
Time frame: Analysis occurs after all patients have been potentially followed for 5 years.
5-Year Freedom From Progression Rate by Ethnicity
NIH-required analysis. A Freedom from Progression (FFP) failure includes biochemical failure, local failure, distant failure, or death due to any cause. Patients who are failure free with less than 5 years of follow-up or who receive any secondary salvage therapy are censored. Freedom from Progression rates are estimated using the Kaplan-Meier method.
Time frame: From randomization to 5 years
5-Year Freedom From Progression Rate by Race
NIH-required analysis. A Freedom from Progression (FFP) failure includes biochemical failure, local failure, distant failure, or death due to any cause. Patients who are failure free with less than 5 years of follow-up or who receive any secondary salvage therapy are censored. Freedom from Progression rates are estimated using the Kaplan-Meier method.
Time frame: From randomization to 5 years
| Milestone | EBRT + Brachytherapy | Brachytherapy Only |
|---|---|---|
| Started | 292 | 296 |
| Eligible patients | 287 | 292 |
| Has acute adverse event data | 282 | 288 |
| Has late adverse event data | 282 | 287 |
| Completed | 287 | 292 |
| Not completed | 5 | 4 |
| Withdrew: Protocol violation | 3 | 3 |
| Withdrew: Withdrawal by subject | 2 | 1 |
A Freedom from Progression (FFP) failure includes biochemical failure, local failure, distant failure, or death due to any cause. Patients who are failure free with less than 5 years of follow-up or who receive any secondary salvage therapy are censored. Freedom from Progression rates are estimated using the Kaplan-Meier method.
| percentage of participants | EBRT + Brachytherapy | Brachytherapy Only |
|---|---|---|
| 5-Year Freedom From Progression Rate | 85.5 (81.3 to 89.7) | 83.1 (78.7 to 87.5) |
Biochemical failure is defined as having 3 consecutive rises of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before 3 consecutive elevations are documented. The sum of the 3 consecutive rises must exceed 1 ng/mL above the nadir. If 3 consecutive PSA rises occur during the first 24 months followed by a subsequent non-hormonal induced PSA decrease, patients will not be considered PSA failures. Three consecutive rises with any of the 3 PSA values occurring more than 24 months after the implant procedure will constitute a failure. Time to biochemical is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. Five year rates are reported.
| percentage of participants | EBRT + Brachytherapy | Brachytherapy Only |
|---|---|---|
| Biochemical Failure Rate (Protocol Definition) | 10.5 (7.2 to 14.4) | 10.5 (7.3 to 14.4) |
Biochemical Failure is defined as an increase of 2 ng/ml or more in PSA over the nadir PSA after 24 months from the start of treatment or the start of salvage hormones. Time to biochemical is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. Five year rates are reported.
| percentage of participants | EBRT + Brachytherapy | Brachytherapy Only |
|---|---|---|
| Biochemical Failure (Phoenix Definition) | 8.0 (5.2 to 11.6) | 8.1 (5.3 to 11.7) |
Prostate cancer death is defined as death due to prostate cancer or complications of treatment or death associated with any of the following: 1) further clinical tumor progression occurring after initiation of salvage androgen suppression therapy; 2) a rise that exceeds 1.0 ng/ml in the serum PSA level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy; and 3) disease progression in the absence of any anti-tumor therapy. Time to prostate cancer death is defined as time from randomization to the date of prostate cancer death, last known follow-up (censored), or death without prostate cancer (competing risk). Prostate cancer death rates are estimated using the cumulative incidence method. Five year rates are reported.
| percentage of participants | EBRT + Brachytherapy | Brachytherapy Only |
|---|---|---|
| Prostate Cancer Death | 0.4 (0.0 to 1.9) | 1.1 (0.3 to 2.9) |
Failure is defined as progression (increase in palpable abnormality) at any time, failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Histologic criteria for local failure are presence of prostatic carcinoma upon biopsy and positive biopsy of the palpably normal prostate more than two years after the start of treatment. Time to local failure is defined as time from randomization to the date of first local failure, last known follow-up (censored), or death without local failure (competing risk). Local failure rates are estimated using the cumulative incidence method. Five year rates are reported.
| percentage of participants | EBRT + Brachytherapy | Brachytherapy Only |
|---|---|---|
| Local Failure | 1.5 (0.5 to 3.5) | 1.1 (0.3 to 2.9) |
Failure is defined as the appearance of any distant metastases. Time to distant metastases is defined as time from randomization to the date of first distant metastases, last known follow-up (censored), or death without distant metastases (competing risk). Distant metastases rates are estimated using the cumulative incidence method. Five year rates are reported.
| percentage of participants | EBRT + Brachytherapy | Brachytherapy Only |
|---|---|---|
| Distant Metastases | 2.9 (1.4 to 5.4) | 2.1 (0.9 to 4.4) |
Failure is defined as death due to any cause. Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Survival rates are estimated using the Kaplan-Meier method. Five year rates are reported.
| percentage of participants | EBRT + Brachytherapy | Brachytherapy Only |
|---|---|---|
| Overall Survival | 95.3 (92.8 to 97.8) | 93.2 (90.3 to 96.2) |
Acute toxicities are scored according to NCI Common Toxicity Criteria (CTC) version 2.0 and will be defined as the worst severity of the toxicity occurring ≤ 180 days from start of radiation. The CTC v 2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to based.
| percentage of participants | EBRT + Brachytherapy | Brachytherapy Only |
|---|---|---|
| Grade 2+ GU/GI | 24.1 (19.5 to 29.4) | 21.9 (17.5 to 27.0) |
| Grade 2+ Overall | 27.7 (22.8 to 33.2) | 26.4 (21.6 to 31.8) |
| Grade 3+ GU/GI | 6.0 (3.7 to 9.5) | 5.6 (3.4 to 8.9) |
| Grade 3+ Overall | 7.8 (5.2 to 11.6) | 8.3 (5.6 to 12.2) |
Late toxicities are scored according to the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Scheme and will be defined as the worst severity of the toxicity occurring \> 180 days from radiation start. Grade 3+ GU/GI and overall were analyzed. RTOG/EORTC Late Radiation Morbidity Scoring Scheme assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. Time to late grade 3+ toxicity is defined as time from randomization to the date of first late grade 3+ toxicity, last known follow-up (censored), or death without late grade 3+ toxicity (competing risk). Late grade 3+ toxicity rates are estimated using the cumulative incidence method. Five year rates are reported.
| percentage of participants | EBRT + Brachytherapy | Brachytherapy Only |
|---|---|---|
| Grade 3+ GU/GI | 7.9 (5.1 to 11.4) | 3.8 (2.0 to 6.5) |
| Grade 3+ Overall | 10.4 (7.2 to 14.3) | 6.6 (4.1 to 9.9) |
The EPIC form is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal function). The urinary domain summary score can be separated into 2 distinct subscales: urinary incontinence and urinary irritative. Hormonal domain was excluded as concurrent use of hormones was exclusionary and prior neoadjuvant hormone use was low. Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. The change score was calculated as the value at 4 months minus the value at baseline. A negative change reflects a decline at 4 months and a positive change reflects an improvement at 4 months.
| units on a scale | EBRT + Brachytherapy | Brachytherapy Only |
|---|---|---|
| Urinary | -20.1 ± 15.4 | -14.1 ± 14.8 |
| Urinary-Incontinence | -10.3 ± 17.7 | -8.7 ± 17.7 |
| Urinary-Irritative | -23.6 ± 18.1 | -15.9 ± 17.3 |
| Bowel | -10.4 ± 13.6 | -6.3 ± 12.7 |
| Sexual | -13.7 ± 22.3 | -11.2 ± 21.0 |
The EPIC form is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal function). The urinary domain summary score can be separated into 2 distinct subscales: urinary incontinence and urinary irritative. Hormonal domain was excluded as concurrent use of hormones was exclusionary and prior neoadjuvant hormone use was low. Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. The change score was calculated as the value at 24 months minus the value at baseline. A negative change reflects a decline at 24 months and a positive change reflects an improvement at 24 months.
| units on a scale | EBRT + Brachytherapy | Brachytherapy Only |
|---|---|---|
| Urinary | -11.2 ± 15.7 | -5.6 ± 13.6 |
| Urinary- Incontinence | -7.6 ± 17.7 | -6.3 ± 15.5 |
| Urinary-Irritative | -11.9 ± 17.4 | -4.8 ± 14.3 |
| Bowel | -7.1 ± 12.6 | -2.4 ± 9.9 |
| Sexual | -16.7 ± 23.4 | -10.6 ± 21.0 |
The AUA-SI is a validated 7-item measure used to assess urinary symptoms. A higher score indicates more severe symptoms for the individual questions and overall total. Six questions ask about frequency of symptoms over the past month with possible responses: 0= Not at all; 1 = Less than 1 time in 5; 2 = less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. An additional question asks the number of times one gets up to urinate after going to bed, with response indicating the exact number of times ranging from 0 to 5. The total score is the sum of the questions and ranges from 0 to 35. Change is calculated as follow-up timepoint score - baseline score such that a negative change reflects an improvement at the follow-up timepoint and a positive change reflects a decline at the follow-up timepoint.
| units on a scale | EBRT + Brachytherapy | Brachytherapy Only |
|---|---|---|
| Change in Total American Urological Association Symptom Index (AUA-SI) Score From Baseline to 4 Months | 10.12 ± 7.94 | 7.77 ± 7.44 |
The AUA-SI is a validated 7-item measure used to assess urinary symptoms. A higher score indicates more severe symptoms for the individual questions and overall total. Six questions ask about frequency of symptoms over the past month with possible responses: 0= Not at all; 1 = Less than 1 time in 5; 2 = less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. An additional question asks the number of times one gets up to urinate after going to bed, with response indicating the exact number of times ranging from 0 to 5. The total score is the sum of the questions and ranges from 0 to 35. Change is calculated as follow-up timepoint score - baseline score such that a negative change reflects an improvement at the follow-up timepoint and a positive change reflects a decline at the follow-up timepoint.
| units on a scale | EBRT + Brachytherapy | Brachytherapy Only |
|---|---|---|
| Change in Total American Urological Association Symptom Index (AUA-SI) Score From Baseline to 24 Months | 4.54 ± 6.94 | 2.37 ± 6.05 |
The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The change score was calculated as the value at the follow-up timepoint minus the value at baseline. A negative change reflects a decline at the follow-up timepoint and a positive change reflects an improvement at the follow-up timepoint.
| units on a scale | EBRT + Brachytherapy | Brachytherapy Only |
|---|---|---|
| VAS Score | -2.71 ± 20.26 | -0.44 ± 17.10 |
| Index Score | -0.01 ± 0.11 | -0.01 ± 0.12 |
The EQ5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The change score was calculated as the value at the follow-up timepoint minus the value at baseline. A negative change reflects a decline at the follow-up timepoint and a positive change reflects an improvement at the follow-up timepoint.
| units on a scale | EBRT + Brachytherapy | Brachytherapy Only |
|---|---|---|
| VAS Score | -0.28 ± 17.56 | -0.57 ± 14.94 |
| Index Score | -0.02 ± 0.12 | -0.01 ± 0.12 |
| Participants | EBRT + Brachytherapy | Brachytherapy Only |
|---|---|---|
| Feasibility of Collecting Medicare Data in a Large RTOG Prostate Cancer Clinical Trial for Cost Effectiveness and Cost Utility Analysis of Combined Treatment With Interstitial Brachytherapy and External Beam Radiotherapy | 0 | 0 |
NIH-required analysis. A Freedom from Progression (FFP) failure includes biochemical failure, local failure, distant failure, or death due to any cause. Patients who are failure free with less than 5 years of follow-up or who receive any secondary salvage therapy are censored. Freedom from Progression rates are estimated using the Kaplan-Meier method.
| percentage of participants | EBRT + Brachytherapy | Brachytherapy Only |
|---|---|---|
| Hispanic or Latino | 77.1 (48.9 to 100.0) | 60.0 (29.6 to 90.4) |
| Not Hispanic or Latino | 86.0 (81.8 to 90.2) | 83.9 (79.5 to 88.3) |
| Unknown or Not Reported | 66.7 (13.3 to 100.0) | 85.7 (59.8 to 100.0) |
NIH-required analysis. A Freedom from Progression (FFP) failure includes biochemical failure, local failure, distant failure, or death due to any cause. Patients who are failure free with less than 5 years of follow-up or who receive any secondary salvage therapy are censored. Freedom from Progression rates are estimated using the Kaplan-Meier method.
| percentage of participants | EBRT + Brachytherapy | Brachytherapy Only |
|---|---|---|
| American Indian or Alaska Native | 100 (NA to NA) | 100 (NA to NA) |
| Asian | 100 (NA to NA) | 100 (NA to NA) |
| Black or African American | 80.3 (68.7 to 91.8) | 83.6 (73.2 to 94.0) |
| White | 85.7 (81.0 to 90.4) | 82.4 (77.3 to 87.4) |
| More than one race | 100 (NA to NA) | — |
| Unknown or Not Reported | 100 (NA to NA) | 0.0 (0.0 to 100.0) |
Collected over From randomization to last follow-up. Maximum follow-up at time of analysis was 13.9 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EBRT + Brachytherapy | 46/282 (16.3%) | 52/282 (18.4%) | 220/282 (78%) |
| Brachytherapy Only | 55/288 (19.1%) | 41/288 (14.2%) | 208/288 (72.2%) |
| Event | EBRT + Brachytherapy | Brachytherapy Only |
|---|---|---|
| Late RT Toxicity: Bladder/Other GU : NOSRenal and urinary disorders | 22/282 | 9/288 |
| Late RT Toxicity: Other : NOSGeneral disorders and administration site conditions | 14/282 | 9/288 |
| Urinary frequencyRenal and urinary disorders | 10/282 | 7/288 |
| Late RT Toxicity: Small/Large Intestine: NOSGastrointestinal disorders | 6/282 | 3/288 |
| ImpotenceReproductive system and breast disorders | 1/282 | 6/288 |
| Urinary retentionRenal and urinary disorders | 4/282 | 4/288 |
| Late RT Toxicity: Other GI : NOSGastrointestinal disorders | 1/282 | 3/288 |
| DysuriaRenal and urinary disorders | 1/282 | 2/288 |
| Hemoglobin decreasedBlood and lymphatic system disorders | 1/282 | 0/288 |
| Myocardial ischaemiaCardiac disorders | 1/282 | 0/288 |
| Event | EBRT + Brachytherapy | Brachytherapy Only |
|---|---|---|
| Late RT Toxicity: Bladder/Other GU : NOSRenal and urinary disorders | 160/282 | 147/288 |
| Late RT Toxicity: Other : NOSGeneral disorders and administration site conditions | 121/282 | 99/288 |
| Urinary frequencyRenal and urinary disorders | 96/282 | 88/288 |
| Late RT Toxicity: Small/Large Intestine: NOSGastrointestinal disorders | 88/282 | 37/288 |
| Late RT Toxicity: Other GI : NOSGastrointestinal disorders | 78/282 | 34/288 |
| DysuriaRenal and urinary disorders | 52/282 | 28/288 |
| Urinary retentionRenal and urinary disorders | 26/282 | 36/288 |
| Diarrhea NOSGastrointestinal disorders | 26/282 | 6/288 |
| FatigueGeneral disorders and administration site conditions | 25/282 | 4/288 |
Eligible Patients
| Age, Customized(Participants) | EBRT + Brachytherapy | Brachytherapy Only | Total |
|---|---|---|---|
| ≤ 59 | 41 | 51 | 92 |
| 60-69 | 141 | 134 | 275 |
| 70-79 | 102 | 103 | 205 |
| ≥ 80 | 3 | 4 | 7 |
| Sex: Female, Male(Participants) | EBRT + Brachytherapy | Brachytherapy Only | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 287 | 292 | 579 |
| Ethnicity (NIH/OMB)(Participants) | EBRT + Brachytherapy | Brachytherapy Only | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 10 | 20 |
| Not Hispanic or Latino | 274 | 275 | 549 |
| Unknown or Not Reported | 3 | 7 | 10 |
| Race (NIH/OMB)(Participants) | EBRT + Brachytherapy | Brachytherapy Only | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 2 | 5 |
| Asian | 5 | 11 | 16 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 50 | 52 | 102 |
| White | 223 | 226 | 449 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 4 | 1 | 5 |
| Baseline Prostate Specific Antigen (PSA)(Participants) | EBRT + Brachytherapy | Brachytherapy Only | Total |
|---|---|---|---|
| 0-<10 ng/ml | 256 | 261 | 517 |
| 10-20 ng/ml | 31 | 31 | 62 |
| Zubrod Performance Status(Participants) | EBRT + Brachytherapy | Brachytherapy Only | Total |
|---|---|---|---|
| 0 | 275 | 281 | 556 |
| 1 | 12 | 11 | 23 |
| Combined Gleason Score (GS)(Participants) | EBRT + Brachytherapy | Brachytherapy Only | Total |
|---|---|---|---|
| ≤ 6 | 31 | 32 | 63 |
| 7 | 256 | 260 | 516 |
| Gleason Score & PSA(Participants) | EBRT + Brachytherapy | Brachytherapy Only | Total |
|---|---|---|---|
| GS<7 and PSA 10-20 | 31 | 32 | 63 |
| GS 7 and PSA < 10 | 256 | 260 | 516 |
2 further baseline measures are reported on the registry.
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