Hypofractionated Adaptive Image-Guided Radiation Therapy for Localized Adenocarcinoma of the Prostate
This will be a Phase II study evaluating the effectiveness and toxicity of a specific radiation therapy regimen. This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens. The total dose is calculated to be effective for late effects which has been shown to be effective and safe in a large prospective Phase II study. If the hypothesis for the prostate is is true, then this regimen should be at least as effective or more effective for tumor control than the current conventional therapy.
Inclusion Criteria: -Histologically confirmed, locally confined adenocarcinoma of the prostate -Clinical stages T1a to T2c PSA of less than 20 ng per ml -Gleason score of less than 8 -The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer -Signed study-specific consent form prior to registration Exclusion Criteria: -Stage T3 to 4 disease -Gleason 8 or higher score -PSA greater than 20 ng per ml -Clinical or Pathological Lymph node involvement N1 -Evidence of distant metastases M1 -Radical surgery for carcinoma of the prostate -Previous Chemotherapy or pelvic radiation therapy -Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years -History of inflammatory bowel disease -Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up
This will be a Phase II study evaluating the effectiveness and toxicity of a regimen of 3.2 Gy daily fractions to a total dose of 67.2 Gy. This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens of 2.5 Gy, 2.7 Gy, and 3.0 Gy daily fractions. The total dose is calculated to be iso-effective for late effects to a conventionally fractionated total dose of 81 Gy, which has been shown to be effective and safe in a large prospective Phase II study. If the alpha/beta ratio for prostate is between 1.5-3.0, then this regimen should be at least as effective or more effective for tumor control than 81 Gy given in conventional fractions.
06/19/2013 04:02 AM