Prostate cancer trial tests whether adding hormone therapy to radiation boosts success
NCT ID NCT01492972
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times
Summary
This phase 3 study is testing whether adding a short course of hormone therapy (androgen suppression) to image-guided radiation therapy helps men with intermediate-risk prostate cancer. About 192 men will receive either radiation alone or radiation plus hormone therapy. The goal is to see if the combination reduces the chance of cancer returning, while also tracking side effects and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Androgen suppression therapy (leuprolide, goserelin, buserelin, or triptorelin)
- What this could lead to
- If successful, this could show that adding short-term hormone therapy to radiation helps keep prostate cancer from coming back in men with intermediate-risk disease.
- What could go wrong
- This is an ongoing phase 3 trial, so results are not yet known. Hormone therapy can cause side effects like hot flashes, fatigue, and sexual problems, and it may not improve outcomes enough to justify those risks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 192 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Jan 2012
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hampton University Proton Therapy Institute
RECRUITINGHampton, Virginia, 23666, United States
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Mayo Clinic
RECRUITINGScottsdale, Arizona, 85259-5499, United States
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Northwestern Medicine Chicago Proton Center
RECRUITINGWarrenville, Illinois, 60555, United States
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Oklahoma Proton Center
RECRUITINGOklahoma City, Oklahoma, 73142, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Radioactive missile aims at prostate cancer that spread
- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains