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Medline ® Abstract for Reference 23

of 'Rising serum PSA after treatment for localized prostate cancer: Systemic therapy'

Efficacy of peripheral androgen blockade in prostate cancer patients with biochemical failure after definitive local therapy: results of Cancer and Leukemia Group B (CALGB) 9782.
Monk JP, Halabi S, Picus J, Hussain A, Philips G, Kaplan E, Ahles T, Gu L, Vogelzang N, Kelly WK, Small EJ, Cancer and Leukemia Group B
Cancer. 2012;118(17):4139. Epub 2011 Dec 16.
BACKGROUND: The treatment for prostate cancer patients with biochemical failure after local therapy remains controversial. Peripheral androgen blockade using a combination of a 5-alpha reductase inhibitor and an antiandrogen may allow control of the prostate-specific antigen (PSA). Because testosterone levels are not suppressed, this approach may be associated with less morbidity than conventional gonadal androgen suppression.
METHODS: All patients had undergone previous definitive local therapy and had evidence of a rising PSA>1ng/mL, with no evidence of recurrent disease. Patients received both finasteride, 5 mg orally per day, and flutamide, 250 mg orally 3×a day. Patients were followed for a PSA response and quality of life assessment.
RESULTS: Ninety-nine of 101 accrued patients were eligible. A≥80% PSA decline was seen in 96 (96%) patients. The median time to PSA progression was 85 months.With a median follow-up of 10 years, the median survival time had not been reached, and the 5-year overall survival rate was 87%. Toxicity was mild, with 18 patients stopping for toxicity; 15 had diarrhea, 4 had gynecomastia, and 3 had transaminase elevation. Baseline Functional Assessment of Cancer Therapy Prostate Module and Treatment Outcome Index scores decreased by 5 points each at 6 months after enrollment.
CONCLUSIONS: The use of the finasteride/flutamide combination is feasible, and results in PSA declines of≥80% in 96% of patients with serologic progression after definitive local therapy. There were no unexpected toxicities, and the change in quality of life was mild. Further evaluation of this or a similar regimen in a controlled clinical trial is warranted.
Division of Oncology, Department of Medicine, The Ohio State University School of Medicine, Columbus, Ohio, USA. Paul.monk@osumc.edu