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

Completed · Phase 1

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT03269422

Run by

Memorial Sloan Kettering Cancer Center

People needed

35

Starts

2017-08-28

Expected to finish

2026-07-29

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Memorial Sloan Kettering Basking Ridge (Consent only and follow up) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
• Memorial Sloan Kettering Commack — Commack, New York, United States
• Memorial Sloan Kettering Westchester — East White Plains, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau (Consent and follow up) — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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