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