Dutasteride as a single agent for low-risk prostate cancer

According to data just reported in The Lancet, some men with low-volume, low-risk prostate cancer may be able to delay progression of their disease if treated only with the 5α-reductase inhibitor dutasteride (Avodart®).

AUA comments on FDA guidance on safe use of 5-ARIs

The American Urological Association (AUA) has written to the U.S. Food & Drug Administration (FDA) seeking modification of the FDA’s recent guidance on the use of 5α-reductase inhibitors like dutasteride and finasteride in the management of urologic conditions.

5α-Reductase inhibitors and risk for high-grade prostate cancer

Yesterday the US Food & Drug Administration (FDA) updated its guidance on the use of 5α-reductase inhibitors with specific reference to the risk that use of these products may be able to induce high-grade (and therefore high-risk) prostate cancer in a small subset of men treated with these agents.

What’s hot at the AUA annual meeting (Monday afternoon)?

It is becoming increasingly clear that the prevention, treatment, and management of prostate cancer is at an intellectual as well as a practical, clinical crossroads.

Screening + chemoprevention in the diagnosis of clinically significant prostate cancer

Monique Roobol and her colleagues continue to mine data from the ERSPC and other major trials in a serious attempt to describe processes that would allow us to identify the vast majority of clinically significant prostate cancers while avoiding the unnecessary diagnosis and over-treatment of indolent disease.

A “last word” from the Genitourinary Cancers Symposium

Over 200 posters and other presentations of new data, as well as many other discussions and lectures, were offered yesterday in the prostate cancer sessions at the Genitourinary Cancers Symposium in Orlando.

The short-term, potential future of prostate cancer prevention

A recent article in the Journal of General Internal Medicine argues that using 5α-reductase (5-ARI) therapy (i.e., with dutasteride or finasteride) to prevent the early onset of prostate cancer is not justified by the available data. … And we entirely agree,

Dutasteride delays progression of prostate cancer in REDEEM trial

The abstract for the presentation of the resulsts of the REDEEM trial (to be presented on Thursday at the Gentourinary Cancer Symposium in Orlando) was published this evening on the ASCO web site. The data show that dutasteride delayed progression of prostate cancer in a well-defined group of patients compared to placebo therapy.

5-ARIs, active surveillance, and prostate cancer progression

We will presumably be at least a little wiser about this issue when data from the REDEEM trial are presented at the Genitourinary Cancers Symposium in Orlando on Thursday; however, data from Canada already suggest that 5α-reductase inhibitors (5-ARIs) affect progression of low-risk forms of prostate cancer.

FDA says no to dutasteride for prostate cancer prevention

Based on the 14 to 2 “against” vote of an Oncology Drugs Advisory Committee meeting late last year, the U.S. Food & Drug Administration has rejected the application to approve dutasteride (Avodart) for prevention of prostate cancer in men at potentially elevated risk for a future postive biopsy.

PSA and risk for prostate cancer in men taking dutasteride

According to further analysis of data from the REDUCE trial, “… men who are taking dutasteride can be confident that the drug does not weaken the ability of PSA to find cancer if it develops. Rather, the drug enhances the ability to find cancer if PSA levels are rising.”

ODAC rejects approval of dutasteride for prostate cancer prevention

Unfortunately — but far from unexpectedly — the Oncology Drugs Advisory Committee (ODAC) to the US Food & Drug Administration today voted against the approval of durasteride for the prevention of prostate cancer in men known to be at elevated risk.

FDA advisory committee to review dutasteride as chemopreventive agent

An FDA advisory committee will meet today to review data on the potential use of dutasteride for the prevention of prostate cancer. The Prostate Cancer Roundtable (including Prostate Cancer International) issued the following media release yesterday.

Approval of dutasteride for reduction in risk for prostate cancer?

On December 1 this year the US Food & Drug Administration’s Oncologic Drug Advisory Committee (ODAC) will meet to hear arguments in favor of — and probably some against — the approval of dutasteride (Avodart) for “the reduction in the risk of prostate cancer in men at increased risk of developing the disease.”

5-ARIs in prevention of prostate cancer — an update

The recent publication of an article on trends in the prescription of finasteride has re-stimulated the debate on the use of 5α-reductase inhibitors (5-ARIs) like finasteride and dutasteride in the prevention of prostate cancer.

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