“ViP Study,” The Effects of Rofecoxib (Trade Name Vioxx) in Reducing the Risk of Prostate Cancer   Sponsor     Merck   Berman Center Site Investigators     PI: Richard Grimm, MD, MPH, PhD Co-Investigator: Philip M. Sweetser, MD, Hennepin Faculty Associates, Division of Urology   Berman Center Site Coordinator     Sandra Graham, RN 612-341-7923   Description     ViP study is a double-blinded, randomized, placebo-controlled trial evaluating the effects of rofecoxib 25mg compared with placebo in decreasing the risk incidence of capsular and extracapsular prostate cancer in men with initially elevated risk.   Role of the Berman Center     Through September 2004, the Berman Center will enroll and follow 25 ViP participants. Berman Center doctors, research nurses, and the collaborating Urologist will complete all study procedures during participants’ clinic visits and also collect study data through telephone call follow-up. Some procedures will be performed at the Hennepin Faculty Associates Radiology facilities.   Basic enrollment information     Participants must be males 50 years of age or older with a Prostate Specific Antigen (PSA) greater than 2.5 ng/mL and less than 10 ng/mL.   Abstract     The ViP study is a double-blinded, randomized, placebo-controlled trial evaluating the effects of rofecoxib 25mg compared with placebo in decreasing the future incidence of prostate cancer among men at initially elevated risk. Approximately 15,000 male patients, aged 50 years or older with a PSA greater than 2.5 ng/mL and less than 10 ng/mL may be eligible to enroll. The study will continue for 6 years after an individual is enrolled. Eligible participants will be randomized to one of the two treatments. Prior to the start of treatment, and then at six-month intervals throughout the 6-year follow-up period, participants will visit the clinical center for a physical examination, laboratory tests, and determination of vital signs. Telephone followup will occur between each six-month visit.