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Short-Term Chemoprevention Trial in Men With Prostatic Intraepithelial Neoplasia Using Flutamide as an Androgen Deprivation Agent

18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Short-Term Chemoprevention Trial in Men With Prostatic Intraepithelial Neoplasia Using Flutamide as an Androgen Deprivation Agent

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.

Inclusion Criteria

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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Prevention

Principal Investigator

Steven R. Alberts, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

August 2000

Completion Date:

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • Neoplasms
  • Prostatic Neoplasms
  • Prostatic Intraepithelial Neoplasia



Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Duluth Duluth, Minnesota  55805
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
Siouxland Hematology-Oncology Sioux City, Iowa  51101-1733
CCOP - Ochsner New Orleans, Louisiana  70121
CentraCare Clinic Saint Cloud, Minnesota  56303
Quain & Ramstad Clinic, P.C. Bismarck, North Dakota  58501
CCOP - Merit Care Hospital Fargo, North Dakota  58122
Altru Health Systems Grand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology Program Toledo, Ohio  43623-3456
CCOP - Geisinger Clinical and Medical Center Danville, Pennsylvania  17822-2001
Rapid City Regional Hospital Rapid City, South Dakota  57709
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
Penn State Geisinger Medical Center Danville, Pennsylvania  17822-2001