CompletedNot Applicable

Hypofractionated Proton Radiation Therapy for Low and Intermediate Risk Prostate Cancer

United States361 participantsStarted 2011-09

Plain-language summary

The purpose of this trial is to give a shorter course (5 ½-6 weeks) of proton radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of proton radiation, without decreasing the chance of killing prostate cancer cells.

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Prostate cancer. * Gleason score 2-6 or 7. * PSA ≤ 20 ng/ml. Exclusion Criteria: * Previous prostate cancer surgery or pelvic radiation. * Prior/concurrent systemic chemotherapy for prostate cancer. * Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum. * History of hip replacement. * Prior intrapelvic surgery. * Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its uses during radiation. * Receiving continuous and current anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), dabigatran etexilate mesylate (Pradaxa),enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).

What they're measuring

Cumulative incidence of treatment-related grade 2 or higher rectal bleeding.

Timeframe: 2 years after completion of radiation therapy

Trial details

NCT IDNCT01368055

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08

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