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Posted by on Apr 18, 2013 in Prostate cancer | 0 comments

In a nutshell

This article presents the results of a phase III clinical trial that evaluated the safety and efficacy of Toremifene (Acapodene) for lowering fracture risk in men with prostate cancer receiving androgen deprivation therapy (ADT). The risk of spinal fractures was significantly reduced in patients who received Toremifene.

Some background

Prostate cancer is fueled by the male hormone testosterone and its related hormones together called androgens. Hormone therapy (also called androgen deprivation therapy or ADT) is used to stop the production of male hormones, thus stopping the growth of the cancer. However, men treated with ADT are at increased risk of developing osteoporosis. This leads to brittle bones and a higher risk of fractures, especially in the spine or hips. Toremifene is a new drug that has been proven effective in reducing the risk of fractures in men with prostate cancer treated with ADT.

Methods & findings

This study included 1284 men with prostate cancer who were treated with ADT. Of these, 646 were randomly assigned to receive toremifene and 638 received placebo (a substance that has no medical effect, used as a control in testing new drugs). After 2 years of follow up there was a 50% lower risk of fractures in the spine for the toremifene group compared to placebo. Also, toremifene significantly reduced the risk of osteoporosis and lowered cholesterol levels. The most common side effects in both groups were joint and back pain, constipation and dizziness. Patients treated with toremifene had a higher risk of developing blood clots (venous thrombosis). 

The bottom line

In summary, toremifene significantly reduced the risk of spine fractures in men with prostate cancer treated with ADT. Additionally, toremifene lowered the risk of osteoporosis and cholesterol levels.

The fine print

Toremifene is not yet approved by the FDA for the prevention of bone fractures in men with prostate cancer treated with ADT. 

This clinical trial was funded by GTx, Inc., the manufacturer of toremifene.

Published By :

Journal of Urology

Date :

Jan 01, 2013

Original Title :

Toremifene to Reduce Fracture Risk in Men Receiving Androgen Deprivation Therapy for Prostate Cancer

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