Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Immediate Versus Delayed Hormone Therapy With Goserelin and Cyproterone Acetate in Treating Patients With Prostate Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Treatment | Closed | any age | EORTC-30846 |
Objectives
I. Determine whether patients with pN1-3 prostatic cancer survive longer with immediate or delayed endocrine management with Zoladex and Androcur.
Entry Criteria
Disease Characteristics:
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
Prior/Concurrent Therapy:
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
Patient Characteristics:
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
Expected Enrollment
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.
Outline
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.Published Results
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 Lead Organizations
European Organization for Research and Treatment of Cancer
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| Fritz Schroeder, MD, PhD, Protocol chair | |
| |
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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.
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