proton radiation therapy in treating patients with prostate cancer

Conditions: Prostate Cancer

Summary: rationale: specialized 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 is studying how well proton radiation therapy works in treating patients with prostate cancer.

detailed description primary objectives: i. feasibility of proton radiation therapy (rt) using standard fractionation. secondary objectives: i. to determine freedom from failure (fff) (vs. biochemical/clinical progression-free survival) with standard fractionation. ii. to determine the incidence of grade 2 or greater gu and gi toxicity with this regimen at 6 months, 2 years and 3 years. iii. to assess quality of life issues following completion of radiation therapy at 6 months and at 2 years. iv. to assess incidence of impotence after the use of proton therapy at 3 years. v. to determine freedom from biochemical failure (bf) at 5 years. vi. to determine clinical failure: local and/or distant at 5 years. vii. to determine salvage androgen deprivation (sad) use at 5 years. viii. to determine progression free survival: using clinical, biochemical and sad as events at 5 years. ix. to determine overall survival at 5 years. x. to determine disease-specific survival at 5 years. xi. estimate prostate and normal structures movement during rt with the use of scans. xii. correlate pathologic and radiologic findings with outcomes at 5 years. xiii. correlate psa and free psa levels with outcomes at 5 years. xiv. correlate testosterone levels and variation with proton therapy and outcomes at 5 years. xv. develop a quality assurance process for proton prostate therapy. outline: patients undergo proton radiotherapy once daily 5 days a week for approximately 9 weeks in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed at 3 months, every 6 months for 5 years, and then annually thereafter.

Eligibility criteria:
inclusion criteria: * histologically confirmed prostate adenocarcinoma within 365 days of registration * clinical stages t1a-t2a n0 m0 * for any pelvic lymph node \>= 1.5cm, biopsy of the lymph node is mandatory * histological evaluation of prostate biopsy with assignment of a gleason score to the biopsy material; gleason score must be in the range 2-6; \> 6 cores is strongly recommended; the highest gleason score in any core reported on the pathology report will be used for determining inclusion * psa values \< 10 ng/ml within 90 days prior to registration, done either prior to prostate biopsy or at least 21 days after prostate biopsy. * alkaline phosphatase within 60 days prior to registration. if alkaline phosphatase is elevated \> 2 x the upper limit of institutional normal (unl), patient must have radiological correlation to assess for metastases * zubrod status 0-1 documented within 60 days of registration * prior androgen deprivation is allowed; however, androgen deprivation will not be continued concurrently or as an adjuvant therapy * patients must give irb-approved study-specific informed consent * patients must complete all required tests listed within the specified time frames * patients must be able to start treatment within 56 days of registration * members of all races and ethnic groups are eligible for this trial exclusion criteria: * clinical stages t2c or greater * psa of 10 ng/ml or greater * gleason score 7 or higher * evidence of distant metastasis * evidence of lymph node involvement * previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery * previous pelvic radiation for prostate cancer * androgen deprivation therapy prior to radiation is allowed; however, it is not acceptable if continued during radiation or as adjuvant therapy * active rectal diverticulitis, crohn's disease, or ulcerative colitis are not allowed * prior systemic chemotherapy for prostate cancer * history of proximal urethral stricture requiring dilatation