Status:
UNKNOWN
Cyproterone Acetate in Treating Patients With Newly Diagnosed Stage III or Stage IV Prostate Cancer
Lead Sponsor:
St. Bartholomew's Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
Up to 79 years
Phase:
PHASE3
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 tre...
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 int...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT00363285
Start Date
January 1 2003
Last Update
August 26 2013
Active Locations (2)
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1
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
2
Scarborough General Hospital
Scarborough, England, United Kingdom, YO12 6QL