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

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.

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, 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 : , 2008.[PUBMED Abstract]

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