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

NCT00363285 | Unknown Phase 3

• 6 other identifiers: CDR0000495321SEUG-9901BARTS-SEUK-9901MREC-04/5/006BARTS-P/02/203EU-20630
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Side effects

• First and total therapy-free intervals in patients treated with intermittent cyproterone acetate

Interventions

gonadotrophin releasing hormone BIOLOGICAL

cyproterone acetate DRUG

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: Up to 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• St. Bartholomew's Hospital: lead

Study Sites (2)

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

RECRUITING

Scarborough General Hospital

Scarborough, England, YO12 6QL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Gonadotropin-Releasing Hormone; Cyproterone Acetate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Cyproterone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Officials

• R. T. Oliver, MD

  St. Bartholomew's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 10, 2006
• First Posted: August 15, 2006
• Study Start: January 1, 2003
• Last Updated: August 26, 2013

Record last verified: 2006-10

Locations

GB (2)