radiation therapy in treating patients with stage ii or stage iii prostate cancer

Conditions: Prostate Cancer

Summary: rationale: radiation therapy uses high-energy x-rays and other sources to damage tumor cells. internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. giving radiation therapy in different ways may kill more tumor cells. purpose: this phase ii trial is studying how well giving internal radiation therapy together with external-beam radiation therapy works in treating patients with stage ii or stage iii prostate cancer.

objectives: primary * determine the rate of late grade 3 or greater genitourinary and gastrointestinal toxicity after treatment with external beam radiotherapy and high-dose rate brachytherapy in patients with stage ii or iii adenocarcinoma of the prostate. secondary * determine acute grade 3 or greater genitourinary and gastrointestinal toxicity in patients treated with this regimen. * determine freedom from biochemical failure in patients treated with this regimen. * determine overall survival of patients treated with this regimen. * determine disease-specific survival of patients treated with this regimen. * determine clinical relapse (local and/or distant) in patients treated with this regimen. * develop a quality assurance process for high-dose rate prostate brachytherapy. outline: this is a multicenter study. patients are stratified according to prostate-specific antigen (≤ 10 ng/ml vs 11-20 ng/ml), t stage (t1c-t2c vs t3a-t3b), combined gleason score (2-6 vs 7 vs 8-10), prior hormonal therapy (no vs yes), and timing of high-dose rate brachytherapy (before external beam radiotherapy vs after external beam radiotherapy). patients are followed at 3, 7, 9, and 12 months, every 6 months for 5 years, and then annually thereafter.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed, adenocarcinoma of the prostate, clinical stage t1c-t3b, n0, m0. 2. patient will have clinically negative nodes as established by imaging (pelvic computed tomography (ct), magnetic resonance imaging (mri)). 3. the patient will be clinically m0. 4. zubrod status 0-1. 5. no prior pelvic or prostate radiation or chemotherapy for prostate cancer; induction hormonal therapy beginning ≤ 120 days prior to registration is acceptable. 6. one of the following combinations of factors: clinical stage t1c-t2c, gleason score 2-6 and prostate-specific antigen (psa) \>10 but ≤ 20 clinical stage t3a-t3b, gleason score 2-6 and psa ≤ 20 clinical stage t1c-t3b, gleason score 7-10 and psa ≤ 20 7. patients must sign a study-specific consent form prior to registration. exclusion criteria: 1. stage t4 disease. 2. lymph node involvement (n1). 3. evidence of distant metastases (m1). 4. radical surgery for carcinoma of the prostate. 5. previous hormonal therapy beginning \> 120 days prior to registration. 6. major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up. 7. prior transurethral resection of the prostate (turp). 8. prior invasive malignancy(except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the oral cavity or bladder are permissible). 9. hip prosthesis.

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