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.

Journal Article (Clinical Trial;Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • 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,

Published Date

  • September 1, 2012

Published In

Volume / Issue

  • 118 / 17

Start / End Page

  • 4139 - 4147

PubMed ID

  • 22180287

Pubmed Central ID

  • PMC5558439

Electronic International Standard Serial Number (EISSN)

  • 1097-0142

Digital Object Identifier (DOI)

  • 10.1002/cncr.26732


  • eng

Conference Location

  • United States