Hypofractionated Proton Radiation Therapy for Low and Intermediate Risk Prostate Cancer

Completed · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01368055

Run by

University of Florida

People needed

361

Starts

2011-09-01

Expected to finish

2025-08-01

Last updated by the study team

2025-08-29

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Prostate cancer.
• Gleason score 2-6 or 7.
• PSA ≤ 20 ng/ml.

You may not qualify if…

• 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).

Where it is running

• University of Florida Proton Therapy Institute — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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