Flutamide In the Prevention of Prostate Cancer in Patients With Neoplasia of the Prostate

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006214
First received: September 11, 2000
Last updated: July 23, 2008
Last verified: December 2007

September 11, 2000
July 23, 2008
August 2000
September 2000   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00006214 on ClinicalTrials.gov Archive Site
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Flutamide In the Prevention of Prostate Cancer in Patients With Neoplasia of the Prostate
Short-Term Chemoprevention Trial in Men With Prostatic Intraepithelial Neoplasia Using Flutamide as an Androgen Deprivation Agent

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.

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.

Interventional
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Allocation: Randomized
Primary Purpose: Prevention
Prostate Cancer
Drug: flutamide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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September 2000   (final data collection date for primary outcome measure)

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

Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00006214
CDR0000067929, NCCTG-959257, MAYO-959257, MAYO-IRB-921-97, NCI-P00-0156
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North Central Cancer Treatment Group
National Cancer Institute (NCI)
Study Chair: Steven R. Alberts, MD Mayo Clinic
National Cancer Institute (NCI)
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP