radiation therapy in treating patients with stage ii prostate cancer

Conditions: Prostate Cancer

Summary: rationale: giving radiation therapy that uses a 3-dimensional (3-d) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving hypofractionated radiation therapy (higher doses over a shorter period of time), may be less costly with fewer side effects and just as effective in treating prostate cancer. purpose: this randomized phase iii trial is studying several different radiation therapy regimens to compare how well they work in treating patients with stage ii prostate cancer.

objectives: primary * compare the disease-free survival (dfs) of patients with favorable-risk stage ii prostate cancer treated with hypofractionated vs conventionally fractionated three-dimensional conformal radiotherapy (3d-crt) or intensity-modulated radiotherapy (imrt). secondary * compare time to local progression, freedom from biochemical recurrence, and disease-specific and overall survival of patients treated with these regimens. * determine the incidence of gastrointestinal and genitourinary toxic effects in patients treated with these regimens. * compare the degree, duration, and significant differences in disease-specific health-related quality of life (hrqol) decrements, using the expanded prostate cancer index composite (epic), in patients treated with these regimens. * determine whether anxiety and/or depression, as measured by the hopkins symptom checklist-25 (hscl-25), are decreased with therapy that improves dfs of these patients . * determine whether the incremental gain in dfs outweighs decrements in the generic domains of hrqol (i.e., mobility, self care, usual activities, pain/discomfort, and anxiety/depression) in patients treated with these regimens. * conduct a cost-utility analysis of hypofractionated 3d-crt or imrt as a prostate cancer therapy if this regimen is shown to be as effective as conventionally fractionated 3d-crt or imrt in improving dfs. outline: this is a randomized, controlled, multicenter study. patients are stratified according to gleason score (2-4 vs 5-6), prostate-specific antigen (psa) level (\< 4 ng/ml vs 4-\<9 ng/ml), and planned radiotherapy modality (three-dimensional conformal radiotherapy \[3d-crt\] vs intensity-modulated radiotherapy \[imrt\]). patients are randomized to 1 of 2 treatment arms. * arm i: patients undergo conventionally fractionated 3d-crt or imrt once daily 5 days a week for 8.2 weeks (total of 41 treatments). * arm ii: patients undergo hypofractionated 3d-crt or imrt once daily 5 days a week for 5.6 weeks (total of 28 treatments). quality of life, anxiety, and depression are assessed at baseline and then at 6 months and 1, 2, and 5 years after the start of radiotherapy. after completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. projected accrual: a total of 1,067 patients will be accrued to this study.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the prostate within the past 6 months * clinical stage t1-2c * combined gleason score 2-6 * prostate-specific antigen (psa) \< 10 ng/ml within the past 6 months * psa evaluated at least 10 days after prostate biopsy * for patients who received finasteride, psa evaluated at least 30 after completion of finasteride * for patients who received dutasteride, psa evaluated at least 90 after completion of dutasteride * no regional lymph node involvement * no distant metastases patient characteristics: * zubrod performance status 0-1 * no unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months * no transmural myocardial infarction within the past 6 months * no acute bacterial or fungal infection requiring iv antibiotics * no chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study treatment * no hepatic insufficiency resulting in clinical jaundice and/or coagulation defects * no known aids * no prior or concurrent lymphomatous/hematogenous malignancy or other invasive malignancy except nonmelanomatous skin cancer or any other cancer for which the patient has been continually disease-free for ≥ 5 years (e.g., carcinoma in situ of the bladder or oral cavity) * no other severe, active comorbidity prior concurrent therapy: * see disease characteristics * no prior radical prostatectomy or cryosurgery for prostate cancer * no prior hormonal therapy, including any of the following: * luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide) * antiandrogens (e.g., flutamide or bicalutamide) * estrogens \[e.g., diethylstilbestrol (des)\] * surgical castration (bilateral orchiectomy) * no prior pelvic radiotherapy or prostate brachytherapy * no prior or concurrent cytotoxic chemotherapy for prostate cancer * at least 30 days since prior finasteride * at least 90 days since prior dutasteride * no concurrent neoadjuvant or adjuvant hormonal therapy * concurrent warfarin or other blood-thinning agents allowed

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