This trial is active, not recruiting.

Condition prostate cancer
Treatments low risk proton radiation, intermediate risk proton radiation
Phase phase 2
Sponsor University of Florida
Start date April 2008
End date June 2012
Trial size 228 participants
Trial identifier NCT00693238, UFPTI 0702-PR04


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
low risk proton radiation
72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
intermediate risk proton radiation

Primary Outcomes

Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate.
time frame: 6 months after the end of radiation therapy

Secondary Outcomes

Disease Control
time frame: 20 years after end of radiation

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria - Prostate cancer. - Gleason score 2-7. - PSA ≤ 20 ng/ml. Exclusion Criteria: - 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.

Additional Information

Official title A Phase II Study of Hypofractionated Image Guided Proton Radiation Therapy for Low and Intermediate Risk Adenocarcinoma of the Prostate
Principal investigator Randal H Henderson, MD
Description Low Risk - Total of 70 Gy/CGE over 28 treatments Intermediate Risk - Total of 72.5 Gy/CGE over 29 treatments
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by University of Florida.