Approval of denosumab for extension of metastasis-free survival in the USA?

According to a media release from Amgen earlier today, the U.S. Food & Drug Administration (FDA) has indicated that a decision will be made by April 26, 2012 about the requested expansion of the indication for denosumab (Xgeva®) to include the prevention of bone metastases in men with non-metastatic, castration-resistant prostate cancer.

FDA publishes analysis of decision not to approve 5-ARIs for prostate cancer prevention

The “New” Prostate Cancer InfoLink is delighted to see Dr. Pazdur and colleagues from the U.S. Food & Drug Administration (FDA) present their reasoning for non-approval of the 5α-reductase inhibitors (5-ARIs) dutasteride and finasteride for prevention of prostate cancer in a new article in the New England Journal of Medicine.

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.

New data suggest that acetaminophen may prevent prostate cancer

Over the years, a variety of studies have demonstrated a possible impact of aspirin and other non-steroidal anti-inflammatory agents or NSAIDs (e.g., ibuprofen, COX-2 inhibitors) on risk for prostate cancer. (See, for example, this report from late in 2010.)

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.

Selenium, vitamin E, soy, and prostate cancer prevention

A new Canadian study just reported in the Journal of Clinical Oncology has failed to find any significant benefit from the use of vitamin E, selenium, and soy protein supplements in the prevention of prostate cancer.

Another update on statins in prostate cancer

Out of the 600+ presentations at the IMPaCT meeting in Orlando last week, your correspondent somehow managed to overlook an interesting poster that offers new evidence in support of the potential benefit of statin therapy in the prevention and management of prostate cancer.

Lancet publishes data on denosumab in men with mCRPC

Full data from the randomized, double-blind, multi-center, Phase III clinical trial comparing denosumab to zoledronic acid in the prevention of skeletal-related events in men with castration-resistant prostate cancer (CRPC) has now been published in The Lancet.

Vitamins, supplements, and prostate cancer-related risk

Many men use vitamins and other supplements to prevent the onset of prostate cancer or to prevent the progression of prostate cancer after diagnosis. However, a new article in Family Practice suggests that there is no really good clinical evidence for either of these practices in the published literature.

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,

The vitamin D saga … another data analysis

Nearly a year ago now we reported data from one relatively large study that suggested there was no direct connection between intake of vitamin D (in its 25-hydroxy vitamin D formulation) and risk for 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.

Could SSRIs be used to manage hot flashes in men on ADT?

There are new data showing that the antidepressant escitalopram (Lexapro/Forest) — a selective serotonin re-uptake inhibitor or SSRI — can significantly reduce hot flashes among women undergoing menopause. If that is the case, one wonders whether drugs of this class might have a similar impact on hot flashes in men on androgen deprivation therapy (ADT).

Denosumab delays onset of bone mets in men with CRPC

According to a media release, issued late yesterday by Amgen, treatment with denosumab can significantly improve bone metastasis-free survival compared to treatment with a placebo in men with castrate-resistant prostate cancer (CRPC), a rising PSA, but no evidence of bone metastases.

It’s enough to make a vegan cry

The full text of a review entitled “Fruit and vegetables and cancer risk” is available on the web site of the British Journal of Cancer, and it is not good news.

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