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Clinical trial Recruiting at 4 sites Phase 3 Interventional Ages 18 and up Men only

Comparing radiation therapy with and without hormone treatment for prostate cancer

Official title: Phase III Study of Image Guided Radiation Therapy With or Without Androgen Suppression for Intermediate Risk Adenocarcinoma of the Prostate

Run by Proton Collaborative Group · NCT01492972 · Data updated 2026-11-12

This study is testing whether adding hormone treatment to radiation therapy can help men with intermediate-risk prostate cancer feel better compared to radiation therapy alone.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment192 (estimated)
SponsorProton Collaborative Group
Research network
Drugs / interventionschemotherapy, radiation
Locations4 sites (Scottsdale, Arizona and 3 other locations)
StatusRecruiting
StartedJanuary 2012
Main results expectedDecember 2027
Registry record updatedSeptember 29, 2026
Trial IDNCT01492972 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are men diagnosed with intermediate-risk prostate adenocarcinoma who meet specific clinical and histological criteria.

Probably not a fit

Patients with advanced prostate cancer or those who do not meet the eligibility criteria may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effects of two treatment approaches for men with intermediate-risk prostate cancer: hypofractionated proton beam radiation therapy alone versus the same radiation therapy combined with androgen suppression. The study will involve 28 sessions of proton therapy and will assess both the positive and negative outcomes of these treatment methods. By comparing these two approaches, the research seeks to determine the potential benefits of adding hormone therapy to radiation treatment.

Why it matters

Potential benefit: If successful, this study could provide insights into more effective treatment options for men with intermediate-risk prostate cancer.

How similar studies have gone: Other studies have explored the use of proton therapy for prostate cancer, but the combination with androgen suppression in this specific context is less commonly tested.

Who can join: the full rules

Show full inclusion / exclusion 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 \< = 20, T stage T2b - T2c
* Clinical stages T1-T2c N0 M0 as staged by the treating investigator. (AJCC Criteria 7th Ed.- appendix III).
* Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range of 2-7. \> 6 cores are strongly recommended.
* PSA values \< = 20 ng/ml within 90 days prior to randomization. Obtained prior to biopsy or at least 21 days after prostate biopsy.
* ECOG performance status 0-1 (appendix II) assessed within 90 days of randomization.
* Patients must sign IRB approved study specific informed consent.
* Patients must complete all required pre-entry tests listed in section 4.0 within the specified time frames.
* Patients must be able to start treatment within 56 days of randomization.
* Patients must be at least 18 years old.
* For brachytherapy, an IPSS ≤ 21, or ≤ 17 if patient is on medications to improve urination.
* For brachytherapy, prostate volume must be less than 55cc prior to AS.

Exclusion Criteria:

* Pelvic lymph nodes \> 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.

Where it's running

  • Mayo Clinic
    Scottsdale, Arizona, United States     Recruiting
  • Northwestern Medicine Chicago Proton Center
    Warrenville, Illinois, United States     Recruiting
  • Oklahoma Proton Center
    Oklahoma City, Oklahoma, United States     Recruiting
  • Hampton University Proton Therapy Institute
    Hampton, Virginia, United States     Recruiting

Study contacts

  • Principal investigator: Carlos Vargas, MD — Proton Collaborative Group

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.