SHIP0804A Phase III, Multicenter, Randomized, Controlled Study of Neoadjuvant LHRH-agonist Therapy and Permanent I-125 Implantation With vs. Without Adjuvant LHRH-agonist Therapy in Patients With Untreated Intermediate-risk Prostate Cancer.

Fecha de inicio: 1 de abril de 2008

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed prostate cancer * Previously untreated disease * Intermediate-risk disease, as defined by the following: * Clinical stage \< T2c * Prostate-specific antigen (PSA) ≤ 20 ng/mL * Gleason score \< 8 PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy ≥ 3 months * Leukocyte count ≥ 3,000/uL * Hemoglobin ≥ 10.0 g/dL * Platelet count ≥ 100,000/uL * Serum creatinine ≤ 2.0 mg/dL * ALT and AST ≤ 100 IU/L * No other cancer requiring treatment * No poorly controlled hypertension (i.e., diastolic blood pressure ≥ 120 mm Hg) * No severe psychiatric disorders, including schizophrenia or dementia * No poorly controlled diabetes * Considered appropriate for study participation, as determined by the Principal Investigator or Clinical Investigator PRIOR CONCURRENT THERAPY: * No prior drugs for benign prostatic hyperplasia (other than antiandrogen therapy) * No prior surgery for prostate cancer * No concurrent steroid drugs (except for ointment) * No other concurrent antiandrogen therapy