Proton Radiation Therapy in Treating Patients With Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This clinical trial is studying how well proton radiation therapy works in treating patients with prostate cancer.

Detailed Description
-----------------
Detailed Description PRIMARY OBJECTIVES: I. Feasibility of proton radiation therapy (RT) using standard fractionation. SECONDARY OBJECTIVES: I. To determine freedom from failure (FFF) (vs. biochemical/clinical progression-free survival) with standard fractionation. II. To determine the incidence of grade 2 or greater GU and GI toxicity with this regimen at 6 months, 2 years and 3 years. III. To assess quality of life issues following completion of radiation therapy at 6 months and at 2 years. IV. To assess incidence of impotence after the use of proton therapy at 3 years. V. To determine freedom from biochemical failure (BF) at 5 years. VI. To determine clinical failure: local and/or distant at 5 years. VII. To determine salvage androgen deprivation (SAD) use at 5 years. VIII. To determine progression free survival: using clinical, biochemical and SAD as events at 5 years. IX. To determine overall survival at 5 years. X. To determine disease-specific survival at 5 years. XI. Estimate prostate and normal structures movement during RT with the use of scans. XII. Correlate pathologic and radiologic findings with outcomes at 5 years. XIII. Correlate PSA and free PSA levels with outcomes at 5 years. XIV. Correlate testosterone levels and variation with proton therapy and outcomes at 5 years. XV. Develop a quality assurance process for proton prostate therapy. OUTLINE: Patients undergo proton radiotherapy once daily 5 days a week for approximately 9 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 3 months, every 6 months for 5 years, and then annually thereafter.

Official Title
-----------------
A Phase II Trial of Proton Radiation Therapy of Using Standard Fractionation for Low-and Low-Intermediate Risk Adenocarcinoma of the Prostate

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Proton Beam Radiation Therapy
* Other: Quality-of-Life assessment
* Other: Questionnaire Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed prostate adenocarcinoma within 365 days of registration Clinical stages T1a-T2a N0 M0 For any pelvic lymph node >= 1.5cm, biopsy of the lymph node is mandatory Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range 2-6; > 6 cores is strongly recommended; the highest Gleason score in any core reported on the pathology report will be used for determining inclusion PSA values < 10 ng/ml within 90 days prior to registration, done either prior to prostate biopsy or at least 21 days after prostate biopsy. Alkaline phosphatase within 60 days prior to registration. If alkaline phosphatase is elevated > 2 x the upper limit of institutional normal (UNL), patient must have radiological correlation to assess for metastases Zubrod status 0-1 documented within 60 days of registration Prior androgen deprivation is allowed; however, androgen deprivation will not be continued concurrently or as an adjuvant therapy Patients must give IRB-approved study-specific informed consent Patients must complete all required tests listed within the specified time frames Patients must be able to start treatment within 56 days of registration Members of all races and ethnic groups are eligible for this trial Exclusion Criteria: Clinical stages T2c or greater PSA of 10 ng/ml or greater Gleason score 7 or higher Evidence of distant metastasis Evidence of lymph node involvement Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery Previous pelvic radiation for prostate cancer Androgen deprivation therapy prior to radiation is allowed; however, it is not acceptable if continued during radiation or as adjuvant therapy Active rectal diverticulitis, Crohn's disease, or ulcerative colitis are not allowed Prior systemic chemotherapy for prostate cancer History of proximal urethral stricture requiring dilatation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients undergo proton radiotherapy once daily 5 days a week for approximately 9 weeks in the absence of disease progression or unacceptable toxicity. | Procedure: Proton Beam Radiation Therapy<br>* Proton Beam Radiation Therapy<br>Other: Quality-of-Life assessment<br>* Quality of Life Assessment<br>Other: Questionnaire Administration<br>* Questionnaire Administration<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| As a feasibility precaution patients will be treated and followed for a minimum of 60 days after completion of radiotherapy to determine feasibility |  | 5 years | 
| Acute toxicity as assessed by NCI CTC Version 3.0 |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late toxicity as assessed by RTOG/EORTC late morbidity scoring system |  | 90 days | 
| Biochemical/clinical progression-free survival |  | Time from start of radiotherapy to either documented increase in PSA or clinical progression of disease, death due to any cause or last patient contact alive |