Recruiting

Proton radiation therapy alone versus with hormone therapy for intermediate prostate cancer

Plain-English translation of NCT01492972 on ClinicalTrials.gov ↗ · Source last updated September 2025 · Translation generated June 2026 · How we translate trials

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Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This study compares two ways to treat prostate cancer that hasn't spread: proton beam radiation therapy alone, or the same radiation combined with (a hormone treatment that blocks male hormones for 6 months). Researchers want to understand whether adding the hormone treatment helps reduce the chance that cancer will return.

Proton beam radiation is an effective treatment for early-stage prostate cancer, but doctors aren't completely sure whether adding hormone-blocking therapy makes it work better. This trial will help answer that question so future patients get the most effective treatment.

Do you qualify?

You likely qualify if…

you have been diagnosed with intermediate-risk prostate cancer confirmed by biopsy within the past year
your prostate cancer has one or more of these risk factors: Gleason score of 7, PSA level between 10 and 20, or a certain tumor stage
your cancer has not spread to lymph nodes or other parts of your body
you are at least 18 years old and in good enough health to tolerate treatment
you can start treatment within 8 weeks of enrollment and complete all required tests beforehand

You likely don't qualify if…

you have had previous prostate cancer surgery or radiation therapy
you have been treated with hormone-blocking therapy for prostate cancer before
you have active inflammatory bowel conditions like Crohn's disease or ulcerative colitis affecting the rectum
you have had a heart attack in the past 6 months
you are taking certain blood thinners like warfarin or clopidogrel that cannot be safely stopped

What participation looks like

If you enroll, you will be randomly assigned to receive either proton beam radiation alone (28 treatments over several weeks) or the same radiation combined with 6 months of hormone-blocking therapy. You'll need to complete pre-treatment testing and then attend regular appointments for radiation sessions and follow-up care to monitor how you're doing and check for any side effects.

AI-generated summary from trial data · Jun 24, 2026 · Not medical advice

Trial locations(4 sites)

United States

Mayo Clinic, Scottsdale, Arizona

Northwestern Medicine Chicago Proton Center, Warrenville, Illinois

Oklahoma Proton Center, Oklahoma City, Oklahoma

Hampton University Proton Therapy Institute, Hampton, Virginia