Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer

About This Trial

This clinical trial is studying whether adding hormone therapy to proton beam radiation works better than radiation therapy alone to treat prostate cancer.
It is designed for adult men diagnosed with intermediate-risk prostate cancer that has not spread to other parts of the body.
Participants will receive 28 radiation treatments, either on their own or alongside medications that lower testosterone to help slow cancer growth.
Before considering this trial, you should know that you cannot join if you have already received surgery, radiation, or hormone treatments for your prostate cancer, or if you have certain active bowel or recent heart conditions.

More Information

The purpose of this study is to compare the effects, good and/or bad of two treatment methods on subjects and their cancer.
Proton beam radiation therapy is one of the treatments for men with prostate cancer who have localized disease.
The benefit of the combination with androgen suppression is not completely understood.
This study will compare the use of hypofraction proton therapy (28 treatments) alone to proton therapy with androgen suppression therapy.

Who Can Enroll

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This clinical trial is studying whether adding hormone therapy to proton beam radiation works better than radiation therapy alone to treat prostate cancer.

Study Details

Start Date: January 2012
Lead Sponsor: Proton Collaborative Group

Full Eligibility Criteria

Inclusion Criteria

Histologically confirmed prostate adenocarcinoma (within 365 days of randomization) at intermediate risk for reoccurrence determined by at least one of the following: Gleason Score 7, PSA > = 10 and 6 cores are strongly recommended.
PSA values 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.
Previous pelvic radiation for prostate cancer.
Previous androgen suppression therapy for prostate cancer.
Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
Prior systemic chemotherapy for prostate cancer.
History of proximal urethral stricture requiring dilatation.
Current and continuing anticoagulation with warfarin sodium (Coumadin), heparin, low- molecular weight heparin, Clopidogrel bisulfate (Plavix), or equivalent (unless it can be stopped to manage treatment related toxicity or to have a biopsy if needed).
Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study).
Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed).
History of myocardial infarction within the last 6 months.