TY - JOUR
T1 - Effect of dutasteride in men receiving intermittent androgen ablation therapy
T2 - The AVIAS trial
AU - Klotz, Laurence
AU - Nabid, Abdenour
AU - Higano, Celestia
AU - Ryanm, Chris
AU - Kebabdjian, Marlene
AU - Chin, Joseph
N1 - Publisher Copyright:
© 2014 Canadian Urological Association.
PY - 2014/11/1
Y1 - 2014/11/1
N2 - 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 prostatespecific 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.
AB - 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 prostatespecific 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.
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U2 - 10.5489/cuaj.2332
DO - 10.5489/cuaj.2332
M3 - Article
AN - SCOPUS:84912526351
SN - 1911-6470
VL - 8
SP - e789-e794
JO - Journal of the Canadian Urological Association
JF - Journal of the Canadian Urological Association
IS - 11-12
ER -