Phase III Immediate vs Delayed Endocrine Therapy with Zoladex and Cyproterone Acetate for Patients with pN1-3M0 Carcinoma of the Prostate
Immediate Versus Delayed Hormone Therapy With Goserelin and Cyproterone Acetate in Treating Patients With Prostate Cancer
Basic Trial Information
|Phase III||Treatment||Closed||any age||EORTC-30846|
I. Determine whether patients with pN1-3 prostatic cancer survive longer with immediate or delayed endocrine management with Zoladex and Androcur.
Histologically proven prostate carcinoma with histologically or cytologically proven N1-3 disease of all T categories No metastases other than lymph node metastases, as determined by the following: Acid phosphatase levels less than 2 x normal No metastases on bone scan, chest x-ray, or ultrasound or CT of the liver No N4 disease on palpation of groin and supraclavicular areas, CT, and lymphangiography
Biologic therapy: No prior therapy for prostate cancer Chemotherapy: No prior therapy for prostate cancer Endocrine therapy: No prior therapy for prostate cancer No prior potentially effective hormonal treatment for other indications Radiotherapy: No prior therapy for prostate cancer Surgery: No prior therapy for prostate cancer other than lymph node dissection and/or lymph node biopsy Prior TUR of the prostate for obstruction allowed
Age: Any age Performance status: 0-2 Life expectancy: More than 1 year Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other malignancy except for adequately treated nonmelanomatous skin cancer
A total of 320 patients (160 patients in each arm) will be entered over about 5 years. As of 09/90, 97 patients had been entered.
Randomized study. Arm I: Endocrine Therapy: LHRH Analogue Therapy plus Short-term Antiandrogen Therapy. Goserelin, Zoladex, ZDX, NSC-606864; plus Cyproterone acetate, CPTR, NSC-81430. Arm II: Observation followed by Endocrine Therapy. Observation until progression; then treatment as in Arm I.
Schröder FH, Kurth KH, Fossa SD, et al.: Early versus delayed endocrine treatment of T2-T3 pN1-3 M0 prostate cancer without local treatment of the primary tumour: final results of European Organisation for the Research and Treatment of Cancer protocol 30846 after 13 years of follow-up (a randomised controlled trial). Eur Urol 55 (1): 14-22, 2009.[PUBMED Abstract]
Schröder FH, Kurth KH, Fossa SD, et al.: Early versus delayed endocrine treatment of pN1-3 M0 prostate cancer without local treatment of the primary tumor: results of European Organisation for the Research and Treatment of Cancer protocol 30846 after 13 years of follow-up - A phase III study. [Abstract] American Society of Clinical Oncology 2008 Genitourinary Cancers Symposium, Feb 14-16, 2008, San Francisco, CA. A-5, 2008.
Schröder FH, Kurth KH, Fosså SD, et al.: Early versus delayed endocrine treatment of pN1-3 M0 prostate cancer without local treatment of the primary tumor: results of European Organisation for the Research and Treatment of Cancer 30846--a phase III study. J Urol 172 (3): 923-7, 2004.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
European Organization for Research and Treatment of Cancer
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.