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Cyproterone Acetate in Treating Patients With Newly Diagnosed Stage III or Stage IV Prostate Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2006 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: August 10, 2006
Last updated: August 23, 2013
Last verified: October 2006

RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy, such as cyproterone acetate may stop the adrenal glands from making androgens. Sometimes the tumor may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving cyproterone acetate continuously is more effective than giving cyproterone acetate after tumor progression in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying cyproterone acetate to compare how well it works when given continuously or after tumor progression in treating patients with newly diagnosed stage III or stage IV prostate cancer.

Condition Intervention Phase
Prostate Cancer
Biological: gonadotrophin releasing hormone
Drug: cyproterone acetate
Procedure: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Intermittent Hormone Therapy for Newly Diagnosed Metastatic Prostate Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to loss of androgen-dependence, based on serum prostate-specific antigen (PSA) failure according to protocol definition
  • Time to treatment failure (subjective or objective progression)
  • Quality of life
  • Survival

Secondary Outcome Measures:
  • Side effects
  • First and total therapy-free intervals in patients treated with intermittent cyproterone acetate

Estimated Enrollment: 900
Study Start Date: January 2003
Detailed Description:



  • Compare time to loss of androgen dependence, based on serum prostate-specific antigen failure, in patients with newly diagnosed stage III or IV prostate cancer treated with intermittent vs continuous androgen suppression comprising cyproterone acetate.
  • Compare time to treatment failure (subjective or objective progression) in patients treated with these regimens.
  • Compare quality of life of patients treated with these regimens.
  • Compare survival of patients treated with these regimens.


  • Compare the side effects in patients treated with these regimens.
  • Determine the first and total therapy-free intervals in patients treated with intermittent cyproterone acetate.

OUTLINE: This is a randomized, multicenter study.

All patients receive cyproterone acetate daily for 16 weeks. Patients also receive monthly injections of luteinizing hormone-releasing hormone (LHRH) agonist beginning in week 2 and continuing for 14 weeks. Patients with a prostate-specific antigen (PSA) level of ≤ 4 ng/mL and who are asymptomatic at 14 weeks are randomized to 1 of 2 treatment arms.

  • Arm I (continuous maximum-androgen blockade): Patients receive cyproterone acetate daily and monthly LHRH agonist depot injections in the absence of disease progression or unacceptable toxicity. Patients may also undergo orchidectomy.

Quality of life is assessed every 6 months for 2 years and then annually thereafter.

  • Arm II (intermittent treatment): Patients are observed after randomization. Treatment with daily cyproterone acetate resumes if symptoms demand hormone treatment and patient has any PSA level OR if patient is asymptomatic and has a PSA level ≥ 20 ng/mL. Treatment continues in the absence of disease progression or unacceptable toxicity. If after 9 months of treatment, a PSA level of ≤ 4 ng/mL is not achieved or the patient remains symptomatic, treatment is discontinued.

Quality of life is assessed every 6 months and when therapy is restarted.

Pain and performance status are assessed at each visit in both treatment arms.

After completion of study therapy, patients are followed periodically.

PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study.


Ages Eligible for Study:   up to 79 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the prostate

    • T3 -T4, M0-M1 (stage III or IV disease)
  • Prostate-specific antigen level ≥ 4 ng/mL and ≤ 100 ng/mL


  • Performance status 0-2
  • Normal liver function
  • No other neoplasia (except skin, excluding melanoma)
  • No expected difficulties of follow-up related to psychiatric disorders, marked senility, or too large a distance between patient's home and investigator's center
  • No severe chronic disease


  • No prior hormonal therapy or chemotherapy
  • No prior surgery (radical prostatectomy), except transurethral resection, for M0 patients
  • No prior radiotherapy to the primary tumor for M0 patients
  Contacts and Locations
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Please refer to this study by its identifier: NCT00363285

United Kingdom
Saint Bartholomew's Hospital Recruiting
London, England, United Kingdom, EC1A 7BE
Contact: R. T. Oliver, MD    44-207-601-8522   
Scarborough General Hospital Recruiting
Scarborough, England, United Kingdom, YO12 6QL
Contact: Simon Hawkyard, MD    44-1723-342-085      
Sponsors and Collaborators
St. Bartholomew's Hospital
Study Chair: R. T. Oliver, MD St. Bartholomew's Hospital
  More Information Identifier: NCT00363285     History of Changes
Other Study ID Numbers: CDR0000495321
Study First Received: August 10, 2006
Last Updated: August 23, 2013

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Cyproterone Acetate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents processed this record on May 25, 2017