Actively Recruiting
Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer
Led by Proton Collaborative Group · Updated on 2025-09-04
192
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hypo-fractionated Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed prostate adenocarcinoma within 365 days before randomization at intermediate risk (Gleason Score 7, PSA 10-20, or T stage T2b-T2c)
- Clinical stage T1-T2c N0 M0 as determined by the investigator
- Gleason score between 2 and 7 assigned to biopsy material; more than 6 cores strongly recommended
- PSA level 20 ng/ml or less within 90 days before randomization, obtained before or at least 21 days after biopsy
- ECOG performance status 0 or 1 assessed within 90 days of randomization
- Signed informed consent approved by the Institutional Review Board
- Completion of all required pre-entry tests within specified time frames
- Able to start treatment within 56 days of randomization
- At least 18 years old
- For brachytherapy candidates, an IPSS score of 21 or less, or 17 or less if on medications for urination
- For brachytherapy, prostate volume less than 55cc before androgen suppression
You will not qualify if you...
- Pelvic lymph nodes larger than 1.5 cm unless biopsied and negative
- Previous prostate cancer surgery including prostatectomy, hyperthermia, or cryosurgery
- Previous pelvic radiation therapy for prostate cancer
- Previous androgen suppression therapy for prostate cancer
- Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis
- Prior systemic chemotherapy for prostate cancer
- History of proximal urethral stricture needing dilation
- Current ongoing use of anticoagulation medications like warfarin, heparin, or Plavix unless stopped for treatment or biopsy
- Major medical, addictive, or psychiatric illness preventing consent, treatment completion, or follow-up
- Any other cancer within the past 5 years with less than 50% chance of 5-year survival (except certain skin cancers)
- History of myocardial infarction within the last 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Mayo Clinic
Scottsdale, Arizona, United States, 85259-5499
Actively Recruiting
2
Northwestern Medicine Chicago Proton Center
Warrenville, Illinois, United States, 60555
Actively Recruiting
3
Oklahoma Proton Center
Oklahoma City, Oklahoma, United States, 73142
Actively Recruiting
4
Hampton University Proton Therapy Institute
Hampton, Virginia, United States, 23666
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here