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BACKGROUND: The treatment for prostate cancer patients with biochemical failure after local therapy remains controversial. Peripheral androgen blockade using a combination of a 5-alpha reductase inhibitor and an antiandrogen may allow control of the prostate-specific antigen (PSA). Because testosterone levels are not suppressed, this approach may be associated with less morbidity than conventional gonadal androgen suppression. METHODS: All patients had undergone previous definitive local therapy and had evidence of a rising PSA >1ng/mL, with no evidence of recurrent disease. Patients received both finasteride, 5 mg orally per day, and flutamide, 250 mg orally 3× a day. Patients were followed for a PSA response and quality of life assessment. RESULTS: Ninety-nine of 101 accrued patients were eligible. A ≥80% PSA decline was seen in 96 (96%) patients. The median time to PSA progression was 85 months. With a median follow-up of 10 years, the median survival time had not been reached, and the 5-year overall survival rate was 87%. Toxicity was mild, with 18 patients stopping for toxicity; 15 had diarrhea, 4 had gynecomastia, and 3 had transaminase elevation. Baseline Functional Assessment of Cancer Therapy Prostate Module and Treatment Outcome Index scores decreased by 5 points each at 6 months after enrollment. CONCLUSIONS: The use of the finasteride/flutamide combination is feasible, and results in PSA declines of ≥80% in 96% of patients with serologic progression after definitive local therapy. There were no unexpected toxicities, and the change in quality of life was mild. Further evaluation of this or a similar regimen in a controlled clinical trial is warranted. Cancer 2012. © 2011 American Cancer Society. [ABSTRACT FROM AUTHOR]

Abstract: Objective: It is hypothesized that dietary patterns, individual nutrients, and specific prescription and over-the-counter medications may influence prostate carcinogenesis. Little information is available regarding the use of these products among men who are participating in prevention trials targeting prostate cancer. Materials and methods: A total of 92 men (mean age 69 years) participating in the Prostate Cancer Prevention Trial (PCPT) at an academic center were asked to bring all nutritional supplements and medications to regularly scheduled study visits. Results: Data were collected on 86 of 92 men. We found that 85% of men in the PCPT regularly consumed at least 1 nutritional supplement. The mean (±standard deviation) number of dietary supplements consumed per man was 3.3 ± 3.5 (range 0–21). A multivitamin and multimineral (73%) supplement was the most common product consumed. Single-nutrient supplements regularly consumed included: vitamin E (48%), vitamin C (31%), calcium (24%), and selenium (7%). Of men, 36% reported consumption of herbal products. Medications frequently consumed during the study period that may influence prostate carcinogenesis included nonsteroidal antiinflammatory drugs (57%), antihypertensives (49%), lipid lowering agents (27%), and aspirin (64%). Conclusions: Participants in the PCPT at an academic center have a high propensity for dietary supplement use. Many, such as vitamin E and selenium, are hypothesized to influence the risk of prostate cancer. Several of the medications commonly consumed, including aspirin, nonsteroidal antiinflammatory drugs, and statins, are being investigated as chemopreventive agents. Investigators designing prostate cancer chemoprevention trials should consider including detailed documentation of exposure to these products that may influence study outcomes. [Copyright &y& Elsevier]