Andrew J Vickers1, Daniel D Sjoberg2. 1. Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY. Electronic address: vickersa@mskcc.org. 2. Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY.
Abstract
OBJECTIVE: To determine whether the additional benefits of improved prostate cancer detection associated with 5α-reductase inhibitors are sufficient to warrant chemoprevention in the case where the degree of prostate cancer risk reduction is deemed inadequate. METHODS: We reanalyzed data from REDUCE, a randomized trial of dutasteride for prostate cancer chemoprevention in men with prior negative biopsy. We evaluated whether statistical models using prostate-specific antigen (PSA) and PSA velocity could help predict the result of repeat prostate biopsy separately for dutasteride and placebo groups. Area under the curve was evaluated by 10-fold cross-validation. RESULTS:PSA velocity improved discrimination at 4 years in the dutasteride group but not at 2 years nor in the placebo group. At 2 years, dutasteride improved discrimination of PSA slightly (0.616 vs. 0.603 for any grade cancer; 0.681 vs. 0.676 for high-grade disease). Between-group differences in cancer rates at 4 years were small. CONCLUSION:Clinicians who are willing to treat at least 23 patients withdutasteride for 2 years to avoid 1 prostate cancer diagnosis should offer dutasteride after initial negative biopsy. Clinicians not willing to do so might consider dutasteride for its additional benefit of reducing unnecessary biopsy, although this benefit is apparent only under very restrictive conditions. It is difficult to justify extending treatment with dutasteride for >2 years.
RCT Entities:
OBJECTIVE: To determine whether the additional benefits of improved prostate cancer detection associated with 5α-reductase inhibitors are sufficient to warrant chemoprevention in the case where the degree of prostate cancer risk reduction is deemed inadequate. METHODS: We reanalyzed data from REDUCE, a randomized trial of dutasteride for prostate cancer chemoprevention in men with prior negative biopsy. We evaluated whether statistical models using prostate-specific antigen (PSA) and PSA velocity could help predict the result of repeat prostate biopsy separately for dutasteride and placebo groups. Area under the curve was evaluated by 10-fold cross-validation. RESULTS:PSA velocity improved discrimination at 4 years in the dutasteride group but not at 2 years nor in the placebo group. At 2 years, dutasteride improved discrimination of PSA slightly (0.616 vs. 0.603 for any grade cancer; 0.681 vs. 0.676 for high-grade disease). Between-group differences in cancer rates at 4 years were small. CONCLUSION: Clinicians who are willing to treat at least 23 patients with dutasteride for 2 years to avoid 1 prostate cancer diagnosis should offer dutasteride after initial negative biopsy. Clinicians not willing to do so might consider dutasteride for its additional benefit of reducing unnecessary biopsy, although this benefit is apparent only under very restrictive conditions. It is difficult to justify extending treatment with dutasteride for >2 years.
Authors: Gerald L Andriole; David Bostwick; Otis W Brawley; Leonard Gomella; Michael Marberger; Francesco Montorsi; Curtis Pettaway; Teuvo L J Tammela; Claudio Teloken; Donald Tindall; Stephen J Freedland; Matthew C Somerville; Timothy H Wilson; Ivy Fowler; Ramiro Castro; Roger S Rittmaster Journal: J Urol Date: 2010-11-12 Impact factor: 7.450
Authors: Gerald L Andriole; David G Bostwick; Otis W Brawley; Leonard G Gomella; Michael Marberger; Francesco Montorsi; Curtis A Pettaway; Teuvo L Tammela; Claudio Teloken; Donald J Tindall; Matthew C Somerville; Timothy H Wilson; Ivy L Fowler; Roger S Rittmaster Journal: N Engl J Med Date: 2010-04-01 Impact factor: 91.245
Authors: Ian M Thompson; Chen Chi; Donna Pauler Ankerst; Phyllis J Goodman; Catherine M Tangen; Scott M Lippman; M Scott Lucia; Howard L Parnes; Charles A Coltman Journal: J Natl Cancer Inst Date: 2006-08-16 Impact factor: 13.506
Authors: Andrew J Vickers; Cathee Till; Catherine M Tangen; Hans Lilja; Ian M Thompson Journal: J Natl Cancer Inst Date: 2011-02-24 Impact factor: 13.506
Authors: Ian M Thompson; Phyllis J Goodman; Catherine M Tangen; M Scott Lucia; Gary J Miller; Leslie G Ford; Michael M Lieber; R Duane Cespedes; James N Atkins; Scott M Lippman; Susie M Carlin; Anne Ryan; Connie M Szczepanek; John J Crowley; Charles A Coltman Journal: N Engl J Med Date: 2003-06-24 Impact factor: 91.245
Authors: M Scott Lucia; Jonathan I Epstein; Phyllis J Goodman; Amy K Darke; Victor E Reuter; Francisco Civantos; Catherine M Tangen; Howard L Parnes; Scott M Lippman; Francisco G La Rosa; Michael W Kattan; E David Crawford; Leslie G Ford; Charles A Coltman; Ian M Thompson Journal: J Natl Cancer Inst Date: 2007-09-11 Impact factor: 13.506
Authors: Ji Eun Heo; Kyo Chul Koo; Sung Joon Hong; Sang Un Park; Byung Ha Chung; Kwang Suk Lee Journal: Yonsei Med J Date: 2018-03 Impact factor: 2.759