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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Feasibility Study of Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR Image-Guided, Intensity-Modulated Radiotherapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: MR-based image-guided, intensity-modulated radiotherapy


Participation Criteria
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Eligibility Criteria
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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: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MR Image Guided, Intensity-Modulated Radiotherapy<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DIL, 17-407, Intermediate Risk Prostate Cancer, Dominant Intra-Prostatic Lesion