Follow-up to REDUCE Study Shows Low Rate of Prostate Cancer Diagnosis
Analysis of 2 years of additional data on dutasteride treatment reported in The Journal of Urology®
New York, NY, January 22, 2013 – The four-year REDUCE (REduction by DUtasteride of prostate Cancer Events) clinical study evaluated prostate cancer risk reduction in men taking dutasteride, a 5-alpha-reductase inhibitor (5ARI) typically used to treat enlarged prostate. REDUCE results showed that dutasteride decreased the risk of biopsy detectable prostate cancer by 22.8 percent compared to a placebo group, but concerns remained about the drug’seffectiveness. Results from a follow-up study are now published in The Journal of Urology®.
“The REDUCE Follow-up Study was a two-year observational follow-up of men who participated in the four-year REDUCE trial,” says lead investigator Robert L. Grubb III, Associate Professor of Surgery (Urology), Washington University of Medicine in St. Louis, Missouri. “The primary objective was to collect data on the occurrence of new cases of prostate cancer for two years beyond REDUCE.”
Nearly 2,800 men from the REDUCE study participated, representing extension safety and at-risk populations. In the original study, about half were treated with dutasteride and the remainder received a placebo.
Shortly after the REDUCE study’s conclusion, Dr. Grubb and co-investigators followed participants with a clinic visit. They also conducted up to two annual telephone calls, collecting patient data on prostate cancer events, chronic medication use, prostate specific antigen levels, and serious adverse events. No drugs were administered and no additional biopsies were performed except those “for-cause” when clinically indicated.
Results showed that few new prostate cancers were detected during the two-year follow-up in either treatment group and no deaths were reported. However, the former dutasteride group produced double the number of cancers than the former placebo group (14 vs. 7). Investigators hypothesize that any prostate cancer that may have been suppressed by dutasteride during REDUCE was no longer being suppressed for those subjects who did not continue on 5ARI therapy. To some extent, observations during the follow-up study support this concept.
Using Gleason scores, the system used to evaluate the prognosis of prostate cancer, no high grade prostate cancers (Gleason Score 8-10) were detected. No new safety issues surfaced.
More men from the placebo group underwent biopsy (11.6 percent) than men from the dutasteride group (7.9 percent). A higher incidence of prostate cancer (1.3 percent) was observed in men in the dutasteride group who did not continue 5ARI treatment. Overall, men in either group who took a 5ARI during the follow-up study tended to have fewer cancers.
“Although this study provides real-world observational data for subjects who had been randomized to four years of dutasteride therapy, it has limitations,” cautions Dr. Grubb. “Men in the at-risk population had a low risk of prostate cancer diagnosis due to several prior negative biopsies and corresponding conclusions are specific to the population studied. In addition, some men who dropped out of REDUCE early may have been off dutasteride treatment for longer than the two-year observational period.”
The two years of additional study have been useful in demonstrating a low rate of new prostate cancer diagnoses among men from the REDUCE study.
Notes for editors
“The REDUCE Follow-up Study: Low Rate of New Prostate Cancer Diagnoses Observed During a 2-year, Observational, Follow-up Study of Men Who Participated in the REDUCE Trial,” by Robert L. Grubb, Gerald L. Andriole, Matthew C. Somerville, Chrysa Mahoney, Michael J. Manyak, Ramiro Castro (DOI: http://dx.doi.org/10.1016/j.juro.2012.09.099). The Journal of Urology, Volume 189, Issue 3 (March 2013) published by Elsevier.
Full text of the article is available to credentialed journalists upon request; contact Linda Gruner at +1-212-633-3923 or firstname.lastname@example.org to obtain copies. To schedule an interview with the authors contact Sally Wahlbrink at +1-314-362-8213 or email@example.com.
About The Journal of Urology®
Established in 1917, The Journal of Urology (www.jurology.com) is the official journal of the American Urological Association (www.auanet.org). It is the most widely read and highly cited journal in the field. It brings to its readership all the clinically relevant information needed to stay at the forefront of this dynamic field. This top-ranking journal presents investigative studies on critical areas of research and practice, survey articles providing short condensations of the best and most important urology literature worldwide and practice-oriented reports on interesting clinical observations.
Elsevier is a world-leading provider of scientific, technical and medical information products and services. The company works in partnership with the global science and health communities to publish more than 2,000 journals, including The Lancet and Cell, and close to 20,000 book titles, including major reference works from Mosby and Saunders. Elsevier’s online solutions include ScienceDirect, Scopus, Reaxys, ClinicalKey and Mosby’s Suite, which enhance the productivity of science and health professionals, and the SciVal suite and MEDai’s Pinpoint Review, which help research and health care institutions deliver better outcomes more cost-effectively.
A global business headquartered in Amsterdam, Elsevier employs 7,000 people worldwide. The company is part of Reed Elsevier Group plc, a world leading provider of professional information solutions. The group employs more than 30,000 people, including more than 15,000 in North America. Reed Elsevier Group plc is owned equally by two parent companies, Reed Elsevier PLC and Reed Elsevier NV. Their shares are traded on the London, Amsterdam and New York Stock Exchanges using the following ticker symbols: London: REL; Amsterdam: REN; New York: RUK and ENL.