REDUCE is an 8,000-patient trial started in 2003 and designed to explore the potential role of dutasteride (Avodart) in reducing the incidence of prostate cancer among men at increased risk for the disease.
The key inclusion criteria for patients to be eligible for this study were:
A single negative prostate biopsy within 6 months prior to enrollment in the study
A PSA (prostate specific antigen) between 2.5 and 10 ng/mL if 50-60 years of age, or a between 3.0 and 10 ng/mL if over age 60
The ability and will to participate in the study for 4 years
The trial is fully enrolled, and the projected trial completed date is not currently known but is unlikely to be earlier that 2012. It is a randomized, double-blind, placebo-controlled trial of the efficacy and safety of dutasteride 0.5 mg administered once daily for 4 years to reduce the risk of biopsy-detectable prostate cancer.
As in the case of the PCPT study, patients who have no diagnosis of prostate cancer during the course of the trial will be required to have a prostate biopsy at the end of the study.
The Physicians Health Study II
This study is a randomized clinical trial with three specific primary goals:
To determine whether vitamin E every other day reduces the risk of developing prostate cancer in older healthy male physicians
To determine whether daily ascorbic acid and/or a multivitamin reduces the risk of total cancer in these participants
To determine whether vitamin E every other day, ascorbic acid daily, or a multivitamin daily reduces the risk of important vascular events in these participants
As with the other two major trials discussed on this page, this trial is already fully enrolled, with over 14,600 participants. All the participants are male physicians of 50 years or older.
The overall goal of this trial is to discover how well vitamin E, ascorbic acid, and/or multivitamins compared to placebos in preventing prostate cancer, other cancers, or cardiovascular disease in healthy older male doctors.
The study is a randomized double-blind, placebo-controlled study and was started in 2005 and has recruited a full complement of 1,590 participants. Participants are randomized to receive either toremifene 20 mg (the study drug) or placebo once daily for 36 months. They will receive regular assessment for effectiveness and safety on a predetermined schedule. It is projected that this trial will be completed some time in 2010.
Key inclusion criteria for eligibility in this trial were:
Being male, and aged ≥ 30 years
Having a diagnosis of high grade PIN from any previous prostate biopsy (as confirmed by the central study pathologist )
Having had a prostate biopsy in the last 6 months that shows no evidence of cancer OR having had two prostate biopsies in the 12 months prior to screening that showed no evidence of cancer with at least one of the biopsies occurring within 6 months prior to the screening visit
Have a serum PSA of ≤ 10 ng/mL
Have adequate bone marrow, liver and renal function according to the trial protocol