intensity-modulated external beam radiation therapy in treating patients with prostate cancer

Conditions: Adenocarcinoma of the Prostate; Stage I Prostate Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer

Summary: rationale: radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. specialized radiation therapy, such as intensity-modulated radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. purpose: this clinical trial studies intensity-modulated external beam radiation therapy in treating patients with prostate cancer.

primary objectives: i. to demonstrate that patients can safely receive imrt teletherapy using the proposed imrt fractionation schedule without experiencing a treatment limiting toxicity. secondary objectives: i. to assess treatment efficacy through the surrogate measures of psa nadir and biochemical failure-free survival. outline: patients undergo hypofractionated intensity modulated radiotherapy once daily, 5 days a week, for 6 weeks in the absence of disease progression or unacceptable toxicity. patients with intermediate- and high-risk disease may also receive concurrent and adjuvant or long-term androgen deprivation therapy for up to 36 months. after completion of study treatment, patients are followed at 4-6 weeks, every 4 months for 3 years, every 6 months for 2 years, and then annually until year 5.

Eligibility criteria:
inclusion criteria: * patients with biopsy-proven adenocarcinoma of the prostate are eligible for protocol enrollment when the following criteria are met; patients must have low, intermediate or high-risk adenocarcinoma of the prostate, as defined by the national comprehensive cancer network (nccn) criteria * a diagnostic ct scan of the abdomen and pelvis will be obtained to rule out regional disease (maximum of 60 days prior to registration) for high-risk patients only * a bone scan showing no evidence of metastatic disease is also required for patients whose prostate-specific antigen (psa) is greater than 20 ng/ml, gleason's sum is greater than 7, or t-stage is greater than t2b * alkaline phosphatase within 1.5 x upper limit of normal (uln) is required for all patients beginning hormone therapy * ast within 1.5 x uln is required for all patients beginning hormone therapy * bilirubin within 1.5 x uln is required for all patients beginning hormone therapy * karnofsky performance score \>= 80 * prior to registration, patients having received no more than three months treatment with anti-androgen, luteinizing hormone-releasing hormone (lhrh) agonist, or a combination of the two remain eligible for protocol treatment; the qualifying psa for these patients will be the value recorded prior to the initiation of the hormone therapy exclusion criteria: * patients with history of inflammatory bowel disease, or who require steroid or cytotoxic therapy for collagen vascular disease * patients with a history of cancer other than skin cancer within five years of the initiation of protocol treatment * patients with a history of pelvic irradiation for any reason

Keywords: imrt prostate cancer radiation therapy external beam recurrent prostate cancer