Phase II study of Dutasteride for recurrent prostate cancer during androgen deprivation therapy.

Article Details

Citation

Copy to clipboard

Shah SK, Trump DL, Sartor O, Tan W, Wilding GE, Mohler JL

Phase II study of Dutasteride for recurrent prostate cancer during androgen deprivation therapy.

J Urol. 2009 Feb;181(2):621-6. doi: 10.1016/j.juro.2008.10.014. Epub 2008 Dec 16.

PubMed ID

19091347 [ View in PubMed

]

Abstract

PURPOSE: We determined the response rate to and safety of a dual 5alpha-reductase inhibitor, dutasteride, in men with castration recurrent prostate cancer. MATERIALS AND METHODS: A total of 28 men with asymptomatic castration recurrent prostate cancer were treated with 3.5 mg dutasteride daily (luteinizing hormone-releasing hormone treatment continued), and evaluated monthly for response and toxicity. Eligibility included appropriate duration antiandrogen withdrawal, baseline prostate specific antigen 2.0 ng/ml or greater and a new lesion on bone scan, increase in measurable disease using Response Evaluation Criteria in Solid Tumors criteria, or 2 or more consecutive prostate specific antigen measurements increased over baseline. Outcomes were progression, stable disease, partial response (prostate specific antigen less than 50% of enrollment for 4 or more weeks) or complete response. RESULTS: There were 25 evaluable men with a mean age of 70 years (range 57 to 88), a mean prostate specific antigen of 61.9 ng/ml (range 5.0 to 488.9) and mean Gleason score 8 (range 6 to 10), 15 of whom had bone metastases. Eight men had 10 grade 3 or higher adverse events using National Cancer Institute Common Terminology Criteria, all of which were judged to be unrelated to treatment. Of the 25 men 14 had disease progression by 2 months, 9 had stable (2.5, 3, 3, 4, 4, 5, 5, 8.5, 9 months) disease, 2 had a partial response and none had a complete response. Overall median time to progression was 1.87 months (range 1 to 10, 95% CI 1.15-3.91). CONCLUSIONS: Dutasteride rarely produces biochemical responses in men with castration recurrent prostate cancer. However, further study is warranted given its favorable safety profile.

DrugBank Data that Cites this Article

Drugs

Dutasteride

Drug Targets

Drug	Target	Kind	Organism	Pharmacological Action	Actions
Dutasteride	3-oxo-5-alpha-steroid 4-dehydrogenase 1	Protein	Humans	Yes	Inhibitor	Details
Dutasteride	3-oxo-5-alpha-steroid 4-dehydrogenase 2	Protein	Humans	Yes	Inhibitor	Details