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

August 23, 2013 updated by: St. Bartholomew's Hospital

Intermittent Hormone Therapy for Newly Diagnosed Metastatic Prostate Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

Study Type

Interventional

Enrollment (Anticipated)

900

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • London, England, United Kingdom, EC1A 7BE
        • Recruiting
        • Saint Bartholomew's Hospital
        • Contact:
      • Scarborough, England, United Kingdom, YO12 6QL
        • Recruiting
        • Scarborough General Hospital
        • Contact:
          • Simon Hawkyard, MD
          • Phone Number: 44-1723-342-085

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 79 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Quality of life
Survival
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)

Secondary Outcome Measures

Outcome Measure
Side effects
First and total therapy-free intervals in patients treated with intermittent cyproterone acetate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Bartholomew's Hospital

Investigators

  • Study Chair: R. T. Oliver, MD, St. Bartholomew's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Registration Dates

First Submitted

August 10, 2006

First Submitted That Met QC Criteria

August 10, 2006

First Posted (ESTIMATE)

August 15, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000495321
  • SEUG-9901
  • BARTS-SEUK-9901
  • MREC-04/5/006
  • BARTS-P/02/203
  • EU-20630

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on quality-of-life assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe