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Toremifene 80 mg: Cancer Care for Men with Prostate Cancer on ADT

GTx is evaluating toremifene citrate 80 mg, a selective estrogen receptor modulator, or SERM, to reduce the risk of fractures in men with prostate cancer on androgen deprivation therapy (ADT).

ADT is the primary treatment for advanced prostate cancer. ADT works by reducing testosterone to castrate levels, thereby depriving prostate cancer of a primary growth factor, and in many patients, it successfully causes the cancer to go into remission for years. Approximately 100,000 men in the U.S. begin ADT each year, and it is estimated that 700,000 men in the U.S. are currently being treated with ADT.¹

By reducing testosterone, ADT also depletes a man’s estrogen, potentially resulting in multiple estrogen deficiency side effects. These estrogen deficiency side effects can include accelerated bone loss with an increased risk of serious fractures; adverse lipid changes and an increased risk of cardiovascular disease and heart attacks; and common symptomatic side effects such as hot flashes and bothersome gynecomastia.

Estrogen is the primary hormone responsible for bone quality and strength. GTx believes one mechanism to manage multiple estrogen deficiency side effects of ADT, including bone loss, is to replace nonselective estrogen with a selective estrogen receptor modulator.

Phase III Clinical Trial

In 2008, GTx completed a pivotal Phase III clinical trial. The two year, double blind, placebo controlled, randomized clinical trial was the first ever fracture prevention study conducted in men on ADT.

In the study, fewer men treated with toremifene 80 mg experienced a new morphometric vertebral fracture compared with men taking placebo, the primary endpoint of the clinical trial. Among the most common adverse events that occurred in over 2% of all study subjects were joint pain (toremifene 7.3%, placebo 11.8%), dizziness (toremifene 6.3%, placebo 5.0%), back pain (toremifene 5.9%, placebo 5.2%) and extremity pain (toremifene 5.0%, placebo 4.4%).

Reference