stereotactic body radiation therapy in treating patients with prostate cancer

Conditions: Prostate Cancer

Summary: rationale: stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. purpose: this phase i/ii trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with prostate cancer.

objectives: primary * to escalate the dose of stereotactic body radiotherapy (sbrt) to a tumoricidal dose without exceeding the maximum tolerated dose in patients with organ-confined prostate cancer. (phase i) * to determine the late, severe grade 3-5 genitourinary and gastrointestinal toxicity occurring between 270-540 days (i.e., 9-18 months) from the start of the protocol treatment as assessed by ctcae v3.0. (phase ii) secondary * to determine the dose-limiting toxicity of sbrt in these patients. (phase i) * to determine the 2-year biochemical (psa) control (freedom from psa failure), disease-free and overall survival, local control, freedom from distant metastases, and the incidence of high-grade adverse events of any type in patients treated with this therapy in order to determine if the therapy is promising enough for further clinical investigation. (phase ii) outline: this is a multicenter, phase i dose-escalation study followed by a phase ii open-label study. * phase i: patients undergo 5 treatments of stereotactic body radiotherapy (sbrt). * phase ii: patients undergo sbrt at the maximum tolerated dose as in phase i. after completion of study treatment, patients are followed at 1.5, 3, 6, 9, and 12 months, every 6 months for 5 years, and then once a year for years 5-10. projected accrual: a total of 97 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the prostate * stage t1a, t1b, t1c disease * stage t2a or t2b * no direct evidence of regional or distant metastases * no t2c, t3, or t4 tumors * gleason score ≤ 7 * must meet the following criteria: * prostate-specific antigen (psa) ≤ 20 ng/ml prior to starting hormonal therapy (if given) for patients with a gleason score of 2-6 * psa ≤ 15 ng/ml prior to starting hormonal therapy (if given) for patients with a gleason score of 7 * risk of pelvic lymph node involvement \< 20% according to roach formula * ultrasound-based volume estimation of the prostate gland ≤ 60 g patient characteristics: * zubrod performance status 0-2 * fertile patients must use effective contraception * no prior invasive malignancy, except for nonmelanoma skin cancer, unless disease-free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are allowed) * no significant urinary obstructive symptoms * american urological association (aua) score of ≤ 15 (alpha blockers allowed) * no history of inflammatory colitis (including crohn disease and ulcerative colitis) * no history of significant psychiatric illness * no severe, active comorbidity including any of the following: * unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months * transmural myocardial infarction within the past 6 months * acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration * hepatic insufficiency resulting in clinical jaundice and/or coagulation defects * laboratory tests for liver function and coagulation parameters are not required for entry into this protocol * aids (based on current cdc definition) or other immunocompromising condition * hiv testing is not required for entry into this protocol prior concurrent therapy: * see disease characteristics * more than 9 months since prior hormonal therapy as neoadjuvant therapy or to downsize the prostate gland * no prior pelvic radiotherapy * no prior chemotherapy or surgery for prostate cancer * no prior transurethral resection of the prostate (turp) or cryotherapy to the prostate * no plans for other concurrent post-treatment, adjuvant, antineoplastic therapy including surgery, cryotherapy, conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy as part of the treatment for prostate cancer

Keywords: adenocarcinoma of the prostate stage i prostate cancer stage iib prostate cancer stage iia prostate cancer