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Emerging Treatment Protocols

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  1. Emerging Treatment Protocols Eric Klein, MD

  2. Phase III Chemoprevention Trials RRR = 22.5% RRR = 23.5% PCPT REDUCE

  3. Prevention: What I Tell Patients • Low calorie diet • Exercise • Vitamin E and Selenium don’t work • Data on other dietary changes and supplements not proven • 5-alpha reductase inhibitors are safe and effective, and the only intervention supported by results of Phase III controlled trials

  4. 5ARIs for Biochemical Recurrence Andriole et al, Urology 45:491, 1995

  5. ARTS Study Design Multicenter, randomized, double-blind, placebo-controlled trial (n=276) End of treatment Randomization Treatment period 2 years Placebo Follow-up Screening Avodart (dutasteride) 0.5mg/day • 3 • weeks 15 21 6 12 18 3 9 0 +4 months 24 Months Baseline Negative bone scan PSA nadir

  6. ARTS Endpoints • Time to PSA doubling (primary) • Time to disease progression and percentage of patients with disease progression • Percentage of patients with treatment response (any PSA decrease or an increase 15%) • Changes in PSA including: • Time to PSA rise and percentage of patients with a PSA rise • Time to PSA progression and percentage of patients with PSA progression • Absolute and percentage PSA change from baseline and nadir PSA • Changes in PSA doubling time during treatment • Disease-related patient anxiety (MAX-PC) • Safety outcomes