Long Term Adjuvant Hormonal Treatment With LHRH Analogue Versus No Further Treatment in Locally Advanced Prostatic Carcinoma Treated by External Irradiation and a Six Months Combined Androgen Blockade - A Phase III Study

Date de début de l'étude : 1 avril 1997

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate T1c-T2a-b, N1-2 or pN1-2 (after pelvic lymphadenectomy) T2c-T4, N0-2 Prior external radiotherapy for locally advanced prostatic carcinoma required Prior hormone therapy (6 months of combined androgen blockade) for locally advanced prostatic carcinoma required with PSA no greater than 150 ng/mL before administration No progressive disease after the 6 months of combined androgen blockage No stages T1c/T2a-b with a negative pelvic lymph nodes status that is assessed clinically or surgically No lymph node involvement to common iliac and/or periaortic lymph nodes (M1a) No external iliac lymph node metastasis more than 5 cm in greatest dimension (N3) No distant metastases PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: At least 5 years Hematopoietic: Hemoglobin at least 10 g/dL WBC at least 2,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Not specified Renal: Not specified Other: No prior or concurrent cancers other than basal cell skin cancer No serious nonmalignant disease resulting in a life expectancy of less than 5 years PRIOR CONCURRENT THERAPY: Biologic therapy No prior biologic therapy for prostate cancer Chemotherapy No prior chemotherapy for prostate cancer Endocrine therapy See Disease Characteristics Radiotherapy See Disease Characteristics Surgery See Disease Characteristics