Effect of dutasteride in men receiving intermittent androgen ablation therapy: The AVIAS trial

Laurence Klotz, Abdenour Nabid, Celestia Higano, Chris Ryan, Marlene Kebabdjian, Joseph Chin

    Research output: Contribution to journalArticle

    5 Scopus citations

    Abstract

    Introduction: We studied the effect of dutasteride on the length of the off-treatment period in prostate cancer patients on intermittent androgen deprivation (IAD) therapy.

    Methods: We conducted a randomized, placebo-controlled Phase II trial in men with localized prostate cancer and a rising prostate-specific antigen (PSA) level post-primary treatment. Patients were randomized to dutasteride (0.5 mg/day) or placebo. All patients received androgen deprivation therapy (ADT), which was stopped at month 9 if the PSA level was <1.0 ng/mL. ADT was resumed when PSA increased to ≥5.0 ng/mL. End points included time off treatment, PSA nadir after 9 months of ADT, serum testosterone and dihydrotestosterone levels, and time to castrate-resistant prostate cancer (rising PSA while testosterone levels remain <50 ng/mL).

    Results: There were 87 evaluable patients: 49 dutasteride, 38 placebo. In total, 80 patients completed one treatment cycle: 45 dutasteride, 35 placebo. The median time off treatment for patients reaching ≥5 ng/mL was 18.6 and 16.7 months for dutasteride and placebo, respectively (p = 0.7600). The median PSA nadir at 9 months was 0.1 and 0.075 ng/mL, respectively (p = 0.4486). There were no cases of androgen-independent prostate cancer. Our study limitations include its short duration with only one treatment cycle evaluated.

    Conclusions: This small-scale Phase II randomized controlled trial showed no benefit to the addition of dutasteride to an IAD regimen.

    Original languageEnglish (US)
    Pages (from-to)e789-e794
    JournalJournal of the Canadian Urological Association
    Volume8
    Issue number11-12
    DOIs
    StatePublished - Nov 1 2014

    Keywords

    • 5 ARI
    • Intermittent androgen deprivation
    • Prostate cancer

    ASJC Scopus subject areas

    • Oncology
    • Urology

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