TY - JOUR
T1 - Chemoprevention of prostate cancer in men at high risk
T2 - Rationale and design of the reduction by dutasteride of prostate cancer events (reduce) trial
AU - Andriole, Gerald
AU - Bostwick, David
AU - Brawley, Otis
AU - Gomella, Leonard
AU - Marberger, Michael
AU - Tindall, Donald
AU - Breed, Sharon
AU - Somerville, Matt
AU - Rittmaster, Roger
N1 - Funding Information:
Supported by GlaxoSmithKline.
PY - 2004/10
Y1 - 2004/10
N2 - Purpose: Chemoprevention may significantly impact the natural history of prostate cancer. The most potent intraprostatic androgen, dihydrotestosterone, has a significant role in the pathophysiology of prostate cancer. It represents a biologically plausible target for chemoprevention through the inhibition of 5α-reductase isoenzymes. Materials and Methods: The Reduction by Dutasteride of Prostate Cancer Events clinical trial is an international, multicenter, double-blind, placebo controlled chemoprevention study designed to determine if dutasteride 0.5 mg daily decreases the risk of biopsy detectable prostate cancer. A total of 8,000 men will be randomized to receive dutasteride or placebo for 4 years. Eligible men must be 50 to 75 years old, have a serum prostate specific antigen of 2.5 to 10 ng/ml (ages 50 to 60 years) or 3.0 to 10 ng/ml (older than 60 years). Men must have a negative 6 to 12 core biopsy within 6 months prior to enrollment. Repeat biopsies will be taken at 2 and 4 years. The rates of prostate cancer for each treatment group will be compared. Genetic and protein biomarkers of prostate cancer, and the effect of dutasteride on benign prostatic hyperplasia and prostatitis symptomatology and histopathology will also be assessed. Results: Results remain to be determined. Conclusions: The study will examine the effects of the dual 5α-reductase inhibitor dutasteride on the natural history of prostate cancer in men at increased risk for this malignancy. It affords a unique opportunity to examine biomarkers and genetic linkage for prostate cancer, and assess a range of prostate health outcome measures.
AB - Purpose: Chemoprevention may significantly impact the natural history of prostate cancer. The most potent intraprostatic androgen, dihydrotestosterone, has a significant role in the pathophysiology of prostate cancer. It represents a biologically plausible target for chemoprevention through the inhibition of 5α-reductase isoenzymes. Materials and Methods: The Reduction by Dutasteride of Prostate Cancer Events clinical trial is an international, multicenter, double-blind, placebo controlled chemoprevention study designed to determine if dutasteride 0.5 mg daily decreases the risk of biopsy detectable prostate cancer. A total of 8,000 men will be randomized to receive dutasteride or placebo for 4 years. Eligible men must be 50 to 75 years old, have a serum prostate specific antigen of 2.5 to 10 ng/ml (ages 50 to 60 years) or 3.0 to 10 ng/ml (older than 60 years). Men must have a negative 6 to 12 core biopsy within 6 months prior to enrollment. Repeat biopsies will be taken at 2 and 4 years. The rates of prostate cancer for each treatment group will be compared. Genetic and protein biomarkers of prostate cancer, and the effect of dutasteride on benign prostatic hyperplasia and prostatitis symptomatology and histopathology will also be assessed. Results: Results remain to be determined. Conclusions: The study will examine the effects of the dual 5α-reductase inhibitor dutasteride on the natural history of prostate cancer in men at increased risk for this malignancy. It affords a unique opportunity to examine biomarkers and genetic linkage for prostate cancer, and assess a range of prostate health outcome measures.
KW - Prostate prostatic neoplasms
UR - http://www.scopus.com/inward/record.url?scp=4544248276&partnerID=8YFLogxK
U2 - 10.1097/01.ju.0000139320.78673.2a
DO - 10.1097/01.ju.0000139320.78673.2a
M3 - Article
C2 - 15371831
AN - SCOPUS:4544248276
SN - 0022-5347
VL - 172
SP - 1314
EP - 1317
JO - Journal of Urology
JF - Journal of Urology
IS - 4 I
ER -