Proton Therapy for Low and Intermediate Risk Prostate Cancer
Not Applicable
Completed
- Conditions
- Prostate Cancer
- Registration Number
- NCT00693238
- Lead Sponsor
- University of Florida
- Brief Summary
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.
- Detailed Description
Low Risk - Total of 70 Gy/CGE over 28 treatments
Intermediate Risk - Total of 72.5 Gy/CGE over 29 treatments
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 228
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate. 6 months after the end of radiation therapy
- Secondary Outcome Measures
Name Time Method Disease Control 20 years after end of radiation
Trial Locations
- Locations (1)
University of Florida Proton Therapy Institute
🇺🇸Jacksonville, Florida, United States
University of Florida Proton Therapy Institute🇺🇸Jacksonville, Florida, United States