Proton Therapy for Low and Intermediate Risk Prostate Cancer
This trial is active, not recruiting.
|Treatments||low risk proton radiation, intermediate risk proton radiation|
|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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
70 Gy/CGE in 28 fractions of 2.5 Gy/CGE/fx
72.5 GY/CGE in 29 fractions of 2.5 Gy/CGE/fx
Acute Grade 3 (NCI CTC v4.0) or Higher Treatment-related Toxicity Rate.
time frame: 6 months after the end of radiation therapy
time frame: 20 years after end of radiation
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.
|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|
Call for more information