Proton 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 weeks) of radiation that has as little side effects on normal bladder and rectal tissues as the usual longer course (8 weeks) of radiation, without decreasing the chance of killing prostate cancer cells.

Key facts

Study ID

NCT00693238

Run by

University of Florida

People needed

228

Starts

2008-04-01

Expected to finish

2022-04-25

Last updated by the study team

2023-09-18

Who can join

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

You may qualify if…

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

You may not qualify if…

• Previous prostate cancer surgery or pelvic radiation.
• Prior or current chemotherapy for prostate cancer.
• Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum.
• History of proximal urethral stricture requiring dilatation.
• History of hip replacement.
• Diabetes requiring medication.
• Prior intrapelvic surgery.
• Current and continuing anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).
• On Flomax (Tamsulosin), Hytrin (Terazosin) or Cardura (Doxazosin), Uroxatral (alfuzosin HCl).
• Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its use during radiation.

Where it is running

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

Full record on ClinicalTrials.gov

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