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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 because the information has not been verified recently.
Verified October 2006 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00363285
First received: August 10, 2006
Last updated: August 23, 2013
Last verified: October 2006
  Purpose

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 [ Designated as safety issue: No ]
  • Time to treatment failure (subjective or objective progression) [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effects [ Designated as safety issue: Yes ]
  • First and total therapy-free intervals in patients treated with intermittent cyproterone acetate [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: January 2003
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.

  Eligibility

Ages Eligible for Study:   up to 79 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363285

Locations
United Kingdom
Saint Bartholomew's Hospital Recruiting
London, England, United Kingdom, EC1A 7BE
Contact: R. T. Oliver, MD    44-207-601-8522    r.t.oliver@qmul.ac.uk   
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
Investigators
Study Chair: R. T. Oliver, MD St. Bartholomew's Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00363285     History of Changes
Other Study ID Numbers: CDR0000495321, SEUG-9901, BARTS-SEUK-9901, MREC-04/5/006, BARTS-P/02/203, EU-20630
Study First Received: August 10, 2006
Last Updated: August 23, 2013
Health Authority: Unspecified

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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Cyproterone
Cyproterone Acetate
Hormones
Androgen Antagonists
Antineoplastic Agents
Contraceptive Agents
Contraceptive Agents, Male
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014