Indian Journal of Urology
: 2014  |  Volume : 30  |  Issue : 1  |  Page : 123--124

Use of dutasteride in carcinoma prostate

RP Shrinivas 

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Shrinivas R P. Use of dutasteride in carcinoma prostate.Indian J Urol 2014;30:123-124

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Shrinivas R P. Use of dutasteride in carcinoma prostate. Indian J Urol [serial online] 2014 [cited 2021 Sep 24 ];30:123-124
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This is a multi-centric randomized, placebo controlled trial with 294 patients with a rising prostate specific antigen (PSA), following radical radiotherapy (RT), radical prostatectomy (RP) with or without salvage radiotherapy, or primary radiotherapy alone for clinically localized prostate carcinoma (PCa) with curative intent, being randomized 1:1 between placebo and dutasteride 0.5 mg once daily for 2 year. The inclusion criteria for the trial was < 85 year and asymptomatic PSA failure. Additional entry criteria included serum PSA levels of 2-20 ng/ml for primary RT group or 0.4-10 ng/ml for primary RP group and other criteria such as PSA doubling time (PSADT), clinical stage, non-metastatic PCa, performance status, etc. The subjects were followed-up with serial PSA measurements and for evidence of any clinical recurrence as and when indicated. 107 patients discontinued therapy primarily because of disease progression (71 [48%] in the placebo group, 36 [24%] in the dutasteride group).

The primary efficacy assessment was the number of days between the start of treatment and the first instance of PSA value being at least twice the last PSA value before the start of treatment. Although the demographics and baseline characteristics were generally similar in the two treatment groups, 15% of patients (43 of 294) had received previous hormonal therapy (15% in the dutasteride group, 14% in the placebo group).

The incidence of PSA doubling reported over the 2 year treatment period was 57% (82 of 144) in the placebo arm and 28% (41 of 146) in the dutasteride arm. The relative risk (RR) for PSA doubling was higher for patients with Gleason score > 7 compared with those with Gleason score < 7 and for those with tumor stage >T1c compared with those with < T1c. They also note that the RR was lower for primary RT subjects compared with RP subjects and for those who used hormonal therapy prior to screening compared with those who did not. Another significant finding noted was the lower incidence of disease progression in the dutasteride group (17%; 25 of 146) compared with the placebo (34%; 49 of 144) in terms of incidence of PSA related progression like PSADT < 3 mo, Absolute high PSA and clinical progression such as positive biopsy, bone metastasis and the need for rescue therapy like anti-androgens or luteinizing hormone-releasing hormone therapy. The incidence of adverse effects was similar between the two groups.


The observation that there is a lower incidence of bone metastasis in the dutasteride group is very significant. As the number of patients in this subgroup was small, it is not sufficiently powered to make a strong conclusion. However, the study suggests the role of safer drug like dutasteride in management of biochemical recurrence after definitive local therapy for localized PCa.

The potential beneficial role of 5-alpha reductase inhibitors (5-ARI) like finasteride in a primary preventive setting as shown by the prostate cancer prevention trial is partly nullified by the increased incidence of sexual adverse effects compared with placebo. [1] Despite a 25% reduction in the incidence of newly diagnosed prostate cancer over a 7-year period, they report an increased risk of high grade Prostate cancer. The role of dutasteride is more acceptable in the secondary preventive setting. Fleshner et al.- reported a randomized double-blind, placebo-controlled multi-centric trial with 302 patients of low volume Gleason 5-6 localized prostate cancers followed with active surveillance, dutasteride and placebo were administered randomly on a 1:1 basis . [2] By 3 years, 54 (38%) of 144 men in the dutasteride group and 70 (48%) of 145 controls had prostate cancer progression. They concluded that dutasteride is a very useful adjunct to active surveillance in the management of low-risk Prostate cancer. Given these facts, the role of dutasteride in the tertiary preventive setting as in the present study looks even more relevant. This has been in conformation with a few other studies (n = 35). [3] However, in a retrospective review of 1315 men who underwent RP, Murtola et al. evaluated the past usage of 5-ARI and alpha-blockers. [4] They noted that 5-ARI usage of 4 years or more was associated with an increased incidence of high grade prostate cancers and also worse progression-free survival, which is in contrast to the present study.

Management of biochemical recurrence following radical therapy for localized prostate cancer is controversial. As the present study tries to address a pertinent question like this, it is imperative to verify how safe a 5-ARI like dutasteride is. This is with specific relevance of 5-ARI to prostate carcinogenesis other than its general adverse effect profile.


1Thompson IM, Goodman PJ, Tangen CM, Lucia MS, Miller GJ, Ford LG, et al. The influence of finasteride on the development of prostate cancer. N Engl J Med 2003;349:215-24.
2Fleshner NE, Lucia MS, Egerdie B, Aaron L, Eure G, Nandy I, et al. Dutasteride in localised prostate cancer management: The REDEEM randomised, double-blind, placebo-controlled trial. Lancet 2012;379:1103-11.
3Perrotti M, Jain R, Abriel LM, Baroni TE, Corbett AB, Tenenbaum SA. Dutasteride monotherapy in men with serologic relapse following radical therapy for adenocarcinoma of the prostate: A pilot study. Urol Oncol 2012;30:133-8.
4Murtola TJ, Kujala PM, Tammela TL. High-grade prostate cancer and biochemical recurrence after radical prostatectomy among men using 5α-reductase inhibitors and alpha-blockers. Prostate 2013;73:923-31.