Emerging Treatment Protocols
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Transcript of Emerging Treatment Protocols
Emerging Treatment Protocols
Eric Klein, MD
Phase III Chemoprevention Trials
RRR = 22.5% RRR = 23.5%
PCPT REDUCEREDUCE
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
5ARIs for Biochemical Recurrence
Andriole et al, Urology 45:491, 1995
ARTS Study DesignMulticenter, randomized, double-blind,
placebo-controlled trial (n=276)
Baseline
Avodart (dutasteride) 0.5mg/day
Placebo
Scr
eeni
ng
Randomization
Fol
low
-up
Treatment period 2 years
-3 weeks
+4 months
Negative bone scan
PSAnadir
End of treatment
3 6 9 12 15 18 21 240Months
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