Dutasteride as a second-line treatment for men failing first-line treatment for localized prostate cancer


New data from the ARTS study, reported in European Urology, suggests that dutateride may have a role in the treatment of men with biochemical failure after radical first-line therapy for prostate cancer.

The ARTS study was a randomized, double-blind, placebo-controlled trial in 294 men recruited at 64 centers in nine European countries. Men showing signs of biochemical failure after first-line therapy for localized prostate cancer were randomized to treatment with either dutasteride (0.5 mg/d) or a placebo.

The primary endpoint of the trial was time to the doubling to a patient’s PSA level from initiation of treatment with dutasteride or the placebo. Secondary endpoints included time to disease progression and the proportion of subjects with disease progression.

As reported by Schröder et al. the core data from this trial are as follows:

  • 147 patients were randomized to dutasteride therapy and another 147 to placebo.
  • 187/294 patients (64 percent) completed 24 months of treatment.
  • 107/294 patients (36 percent) discontinued treatment prematurely.
    • 71/107 patients discontinuing therapy early were in the placebo group.
    • 36/107 patients discontinuing therapy early were in the dutasteride group.
  • A difference in treatment effects between the two groups of patients started to become significant after 6 months
  • After 24 months on treatment,
    • Dutasteride significantly delayed the time to PSA doubling compared with placebo (p < 0.001), and the reduction in relative risk (RR) in favor of dutasteride was 66.1 percent.
    • Dutasteride significantly delayed time to disease progression (including PSA- and non-PSA-related outcomes) compared with placebo (p < 0.001), and  the reduction in the rate of recurrence in favor of dutasteride was 59 percent.
  • The incidence of adverse events (AEs), serious AEs, and AEs leading to study withdrawal were similar between the treatment groups.
  • No fatal AE was considered to be related to study treatment.

A limitation of the study was that the investigators were not blinded to PSA levels during the study.

The authors conclude that dutasteride had delayed the biochemical progression of prostate cancer in patients with biochemical failure after radical therapy for clinically localized disease, and that the safety and tolerability of dutasteride were generally consistent with previous experience.

Now the ARTS study was a relatively small and short-term study, and, as noted by the authors, the investigators were not blinded to the patients PSA levels during the course of the study, which may have introduced investigator bias. Nevertheless, the available data does suggest that treatment with dutasteride has the potential to delay progression of prostate cancer after first-line therapy and initial disease progression in a selected group of men.

The most appropriate form of immediate, second-line treatment of men with relatively low-risk, progressive disease after first-line therapy is not well established. These data from the ARTS study seem to suggest that second-line dutasteride therapy may be an appropriate treatment option for at least some of these patients.

Schröder and his colleagues are clear in their report that a larger study would be helpful in elucidating the potential role of dutasteride in this clinical setting. However, it seems to The “New” Prostate Cancer InfoLink that further study of the role of dutasteride in this setting is probably unlikely, and therefore that clinicians and their patients are going to need to make decisions about the use of dutasteride in this clinical setting based on the (less than completely definitive) data from the current study.

2 Responses

  1. I have taken dutasteride for 6 years and I am convinced it slowed the growth of my cancer. I had a PCA3 of 90, but my 3D mapping biopsy found one core out of 48, 10%, Gleason 3 + 3 = 6.

  2. And, of course, I have always supported the use of dutasteride/Avodart and am another example of this medication definitely slowing the growth of my cancer cells for 2 months short of 6 years while off the ADT LHRH agonist Lupron and antiandrogen bicalutamide. Prior to that, in an earlier off-phase, when not aware of dutasteride/Avodart, my “time off” without dutasteride/Avodart lasted only a year and a half before PSA elevation signaled that time off was over.

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