Status:
COMPLETED
Proton Therapy for Low and Intermediate Risk Prostate Cancer
Lead Sponsor:
University of Florida
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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, w...
Detailed Description
Low Risk - Total of 70 Gy/CGE over 28 treatments Intermediate Risk - Total of 72.5 Gy/CGE over 29 treatments
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2022
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT00693238
Start Date
April 1 2008
End Date
April 25 2022
Last Update
September 18 2023
Active Locations (1)
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1
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206