Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer
Brief summary
RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether surgery is more effective than internal radiation in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with that of internal radiation in treating patients who have stage II prostate cancer.
Detailed description
OBJECTIVES: * Compare overall survival in patients with stage II prostate cancer treated with radical prostatectomy vs brachytherapy. * Compare metastasis-free survival and probability of survival without symptoms of patients treated with these regimens. * Compare the side effects of these treatment regimens in these patients. OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. * Arm I: Patients undergo radical prostatectomy. * Arm II: Patients undergo brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds Patients are followed every 6 months for 5 years and then annually thereafter. PROJECTED ACCRUAL: A total of 1,980 patients (990 per treatment arm) will be accrued for this study within 5.5 years.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate within the past 120 days * T1c-T2a, N0, M0 * No bilateral disease * Prostate-specific antigen (PSA) no greater than 10 ng/mL * In patients with prior neoadjuvant hormonal therapy (NHT), PSA must be less than 10 ng/mL prior to therapy * Gleason score no greater than 6 * Prostate gland less than 60 cc on transrectal ultrasound or with minimal pubic arch interference OR * Prostate gland 60 cc or greater prior to NHT allowed if prostate size has been reduced to less than 60 cc by NHT PATIENT CHARACTERISTICS: Age: * 75 and under Performance status: * ECOG 0-2 OR * Zubrod 0-2 Renal: * Creatinine no greater than 3 mg/dL Cardiovascular: * No significant cardiovascular disease * No New York Heart Association class III or IV heart disease Other: * No other malignancy within the past 5 years except effectively treated basal cell or squamous cell skin cancer or other malignancy at low risk for recurrence * No other condition that would preclude study PRIOR CONCURRENT THERAPY: Endocrine therapy: * See Disease Characteristics * At least 90 days since prior NHT * Duration of therapy no greater than 120 days * No concurrent NHT Radiotherapy: * No prior radiotherapy to pelvis Surgery: * No prior surgery for prostate cancer or benign disease, including: * Transurethral resection of the prostate * Transurethral resection of the bladder neck * Cryotherapy * Laser ablation * Microwave therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | Up to 10 years |
Secondary
| Measure | Time frame |
|---|---|
| disease free survival | Up to 10 years |
Countries
Canada, United States