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  • Last Modified: 10/7/2008

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Phase III Immediate vs Delayed Endocrine Therapy with Zoladex and Cyproterone Acetate for Patients with pN1-3M0 Carcinoma of the Prostate

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Alternate Title

Immediate Versus Delayed Hormone Therapy With Goserelin and Cyproterone Acetate in Treating Patients With Prostate Cancer

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosedany ageEORTC-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 Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Fritz Schroeder, MD, PhD, Protocol chair
Ph: 31-10-463-4328

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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