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| Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006214 |
Purpose
RATIONALE: Chemoprevention therapy is the use of certain drugs such as flutamide to try to prevent the development of cancer. Flutamide may be effective in the prevention of prostate cancer.
PURPOSE: Randomized clinical trial to study the effectiveness of flutamide in preventing prostate cancer in patients who have neoplasia of the prostate.
| Condition | Intervention |
|
Prostate Cancer |
Drug: flutamide |
| MedlinePlus related topics: | Cancer Prostate Cancer |
| ChemIDplus related topics: | Flutamide |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized |
| Official Title: | Short-Term Chemoprevention Trial in Men With Prostatic Intraepithelial Neoplasia Using Flutamide as an Androgen Deprivation Agent |
| Study Start Date: | August 2000 |
| Primary Completion Date: | September 2000 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Determine the ability of flutamide to reduce the incidence of prostate cancer in patients with high grade prostatic intraepithelial neoplasia. II. Determine the effect of this regimen on a series of endpoint biomarkers in these patients. III. Assess the quality of life of these patients.
OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to age (under 65 versus 65 and over), PSA (0-2.5 versus 2.6-4.0 versus 4.1-10 versus greater than 10 ng/mL), PIN (on one biopsy versus on two biopsies), and family history (prostate cancer in brother, father, or uncle versus no prostate cancer in these relatives). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral flutamide once daily. Arm II: Patients receive an oral placebo once daily. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before study, at 1, 6, and 12 months, and then annually therafter. Patients are followed annually for up to 10 years.
PROJECTED ACCRUAL: A total of 212 patients (106 per arm) will be accrued for this study in approximately 2 years.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed high grade prostatic intraepithelial neoplasia Confirmed by second prostate biopsy within 180 days of first biopsy No prior or concurrent prostatic carcinoma No prior hormonal replacement or antiandrogen therapy
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Greater than 5 years Hematopoietic: Not specified Hepatic: SGOT and alkaline phosphatase no greater than 2 times upper limit of normal No hepatitis B or C or liver cirrhosis Renal: Not specified Other: Fertile patients must use effective contraception No other prior malignancy in past 5 years except carcinoma in situ or nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics Radiotherapy: No prior radiotherapy Surgery: Not specified
Contacts and Locations| United States, Arizona | |||||
| CCOP - Scottsdale Oncology Program | |||||
| Scottsdale, Arizona, United States, 85259-5404 | |||||
| United States, Illinois | |||||
| CCOP - Carle Cancer Center | |||||
| Urbana, Illinois, United States, 61801 | |||||
| CCOP - Illinois Oncology Research Association | |||||
| Peoria, Illinois, United States, 61602 | |||||
| United States, Iowa | |||||
| CCOP - Cedar Rapids Oncology Project | |||||
| Cedar Rapids, Iowa, United States, 52403-1206 | |||||
| CCOP - Iowa Oncology Research Association | |||||
| Des Moines, Iowa, United States, 50309-1016 | |||||
| Siouxland Hematology-Oncology | |||||
| Sioux City, Iowa, United States, 51101-1733 | |||||
| United States, Kansas | |||||
| CCOP - Wichita | |||||
| Wichita, Kansas, United States, 67214-3882 | |||||
| United States, Louisiana | |||||
| CCOP - Ochsner | |||||
| New Orleans, Louisiana, United States, 70121 | |||||
| United States, Michigan | |||||
| CCOP - Ann Arbor Regional | |||||
| Ann Arbor, Michigan, United States, 48106 | |||||
| United States, Minnesota | |||||
| CCOP - Duluth | |||||
| Duluth, Minnesota, United States, 55805 | |||||
| CCOP - Metro-Minnesota | |||||
| Saint Louis Park, Minnesota, United States, 55416 | |||||
| CentraCare Clinic | |||||
| Saint Cloud, Minnesota, United States, 56303 | |||||
| Mayo Clinic Cancer Center | |||||
| Rochester, Minnesota, United States, 55905 | |||||
| United States, Nebraska | |||||
| CCOP - Missouri Valley Cancer Consortium | |||||
| Omaha, Nebraska, United States, 68131 | |||||
| United States, North Dakota | |||||
| Altru Health Systems | |||||
| Grand Forks, North Dakota, United States, 58201 | |||||
| CCOP - Merit Care Hospital | |||||
| Fargo, North Dakota, United States, 58122 | |||||
| Quain & Ramstad Clinic, P.C. | |||||
| Bismarck, North Dakota, United States, 58501 | |||||
| United States, Ohio | |||||
| CCOP - Toledo Community Hospital Oncology Program | |||||
| Toledo, Ohio, United States, 43623-3456 | |||||
| United States, Pennsylvania | |||||
| CCOP - Geisinger Clinical and Medical Center | |||||
| Danville, Pennsylvania, United States, 17822-2001 | |||||
| Penn State Geisinger Medical Center | |||||
| Danville, Pennsylvania, United States, 17822-2001 | |||||
| United States, South Dakota | |||||
| CCOP - Sioux Community Cancer Consortium | |||||
| Sioux Falls, South Dakota, United States, 57105-1080 | |||||
| Rapid City Regional Hospital | |||||
| Rapid City, South Dakota, United States, 57709 | |||||
| Canada, Saskatchewan | |||||
| Saskatchewan Cancer Agency | |||||
| Regina, Saskatchewan, Canada, S4S 6X3 | |||||
| North Central Cancer Treatment Group |
| National Cancer Institute (NCI) |
| Study Chair: | Steven R. Alberts, MD | Mayo Clinic |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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| Study ID Numbers: | CDR0000067929, NCCTG-959257, MAYO-959257, MAYO-IRB-921-97, NCI-P00-0156 |
| First Received: | September 11, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006214 |
| Health Authority: | United States: Federal Government |
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