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CompletedNCT03269422Updated Jul 31, 2026

Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL)

A Phase 1 interventional study of MR-based image-guided, intensity-modulated radiotherapy in Prostate Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 7 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study summary

The purpose of the study is to find out the feasibility and effects of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostrate cancer.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • 17-407
  • Intermediate Risk Prostate Cancer
  • DIL
  • Dominant Intra-Prostatic Lesion
03

Who can participate

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

Inclusion criteria

  • Intermediate risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. Intermediate risk patients will be defined as:

    • PSA 10-20 ng/ml or
    • Gleason score = 7 or
    • Clinical stage T2b/T2c
  • Additionally, patients will be required to meet the following criteria:

    • Age >18
    • KPS > 80
    • Prostate size \< 60cc
    • Presence of a prostatic lesion with maximum dimension of >/= 0.5cm and no more than two additional disease foci, each with a maximum dimension less than that of the dominant lesion.
    • International Prostrate Symptom Score \< 15
    • Subjects must fill out the standard MRI screening form and satisfy all MRI screening criteria

Exclusion criteria

Exclusion Criteria:

  • Prior androgen deprivation therapy for prostate cancer
  • Evidence of metastatic disease on bone scan or MRI/CT
  • MRI ineligibility due to the presence of a cardiac pacemaker, defibrillator or other implanted metallic or electronic device which is considered MR unsafe, severe claustrophobia or inability to lie flat for the duration of the study, etc.
  • Metallic hip implant, metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of MP-MRI.
  • Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MRCAT reconstruction
  • Contra-indications to receiving gadolinium contrast
  • KPS \< 80
  • Pelvic MRI or CT (MRI preferred) evidence of radiographic T3, T4 or N1 disease.
  • Prior history of transurethral resection of the prostate
  • Prior history of chronic prostatitis
  • Prior history of urethral stricture
  • Prior history of pelvic irradiation
  • History of inflammatory bowel disease
  • Unable to give informed consent
  • Unable to complete quality of life questionnaires
  • Abnormal complete blood count. Any of the following

    • Platelet count less than 75,000/ml
    • Hb level less than 10 gm/dl
    • WBC less than 3.5/ml
  • Abnormal renal function tests (creatinine > 1.5)
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    MR Image Guided, Intensity-Modulated Radiotherapy

    Patients enrolled in this study will undergo MR-based, image-guided, intensity-modulated radiotherapy using similar equipment, techniques, and treatment-planning procedures as currently practiced at MSKCC.

    Radiation: MR-based image-guided, intensity-modulated radiotherapy

Interventions

  • RadiationMR-based image-guided, intensity-modulated radiotherapy

    Patients will receive a standard dose of 8 Gy/fraction for five fractions for a total dose of 40 Gy to the prostate with a simultaneously delivered boost of 9 Gy for five fractions (clinically non-standard dose of 45 Gy total) to a single dominant lesion with a maximum dimension of at least 0.5 cm as determined on pre-treatment diagnostic T2 MRI imaging.

05

What researchers measure

Primary outcomes

  1. Treatment related toxicity of ultra-hypofractionated radiotherapy will be assessed according to NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity

    Assess toxicity of ultra-hypofractionated radiotherapy to the prostate and dominant lesion as definitive treatment for intermediate risk prostate cancer. Severe Toxicity will be assessed and defined as Grade 3 or higher NCI CTCAE v3.0 gastrointestinal or genitourinary toxicity

    Time frame: 36 months

06

Study locations

7 sites
  • Memorial Sloan Kettering Basking Ridge (Consent only and follow up)
    Basking Ridge, New Jersey 07920, United States
  • Memorial Sloan Kettering Monmouth
    Middletown, New Jersey 07748, United States
  • Memorial Sloan Kettering Bergen
    Montvale, New Jersey 07645, United States
  • Memorial Sloan Kettering Commack
    Commack, New York 11725, United States
  • Memorial Sloan Kettering Westchester
    East White Plains, New York 10604, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
  • Memorial Sloan Kettering Nassau (Consent and follow up)
    Uniondale, New York 11553, United States
07

References and documents

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03269422
Lead sponsor
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
Aug 31, 2017
Start date
Aug 28, 2017
Primary completion
Jul 29, 2026
Completion
Jul 29, 2026
Last update
Jul 31, 2026

Study contacts

Daniel Gorovets, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

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

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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