Prostate Cancer Clinical Trial
Official title:
Intermittent Hormone Therapy for Newly Diagnosed Metastatic Prostate Cancer
Verified date | October 2006 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | Unspecified |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 900 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A to 79 Years |
Eligibility |
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 |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Saint Bartholomew's Hospital | London | England |
United Kingdom | Scarborough General Hospital | Scarborough | England |
Lead Sponsor | Collaborator |
---|---|
St. Bartholomew's Hospital |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to loss of androgen-dependence, based on serum prostate-specific antigen (PSA) failure according to protocol definition | No | ||
Primary | Time to treatment failure (subjective or objective progression) | No | ||
Primary | Quality of life | No | ||
Primary | Survival | No | ||
Secondary | Side effects | Yes | ||
Secondary | First and total therapy-free intervals in patients treated with intermittent cyproterone acetate | No |
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