Hypofractionated Proton Radiation Therapy for Low and Intermediate Risk Prostate Cancer

Study Overview
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Brief Summary
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The purpose of this trial is to give a shorter course (5 ½-6 weeks) of proton radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of proton radiation, without decreasing the chance of killing prostate cancer cells.

Official Title
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An Expanded Phase II Study of Hypofractionated Dose Intense Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: 70 Gy/CGE
* Radiation: 72.5 Gy/CGE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prostate cancer. Gleason score 2-6 or 7. PSA ≤ 20 ng/ml. Exclusion Criteria: Previous prostate cancer surgery or pelvic radiation. Prior/concurrent systemic chemotherapy for prostate cancer. Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. History of hip replacement. Prior intrapelvic surgery. Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its uses during radiation. Receiving continuous and current anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), dabigatran etexilate mesylate (Pradaxa),enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Risk<br>70 Gy/CGE | Radiation: 70 Gy/CGE<br>* Low Risk<br>|
| Experimental: Intermediate Risk<br>72.5 Gy/CGE | Radiation: 72.5 Gy/CGE<br>* Intermediate Risk<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of treatment-related grade 2 or higher rectal bleeding. |  | 2 years after completion of radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyzation of quality of life |  | After radiation: every 6 months for 3 years, then annually for 20 years | 
| Analysis of treatment-related morbidity |  | Cumulative incidence up to 20 years after completion of radiation therapy | 
| Analysis of disease control | Proportion of patients with disease control after completion of treatment | Cumulative incidence up to 20 years after completion of radiation therapy | 
| Analysis of overall survival | Proportion of patients alive after completion of treatment | Cumulative incidence up to 20 years after completion of radiation therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proton Radiation, Prostate Cancer