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Phase II study of dutasteride for recurrent prostate cancer during androgen deprivation therapy
The Journal of Urology, 02/03/09

Shah SK et al. - In a study to determine the response rate to and safety of dutasteride in men with castration recurrent prostate cancer, it was found that dutasteride rarely produces biochemical responses in men with castration recurrent prostate cancer.

• 28 men with asymptomatic castration recurrent prostate cancer were treated with 3.5 mg dutasteride daily, and evaluated monthly for response and toxicity.
• Eligibility included appropriate duration antiandrogen withdrawal, baseline prostate-specific antigen (PSA) 2.0 ng/ml or greater, and a new lesion on bone scan, increase in measurable disease using RECIST criteria, or 2 or more consecutive PSA measurements increased over baseline.
• Outcomes were progression, stable disease, partial response (PSA <50% of enrollment for ≥4 wks) or complete response.

• There were 25 evaluable men with a mean age of 70 yrs, a mean PSA of 61.9 ng/ml and mean Gleason score 8, 15 of whom had bone metastases.
• 8 men had 10 grade 3 or higher adverse events, all of which were unrelated to treatment.
• 14 of 25 men had disease progression by 2 mos, 9 had stable disease, 2 had a partial response, and none had a complete response.
• Overall median time to progression was 1.87 mos.

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