Therapy reduces hot flashes in men with prostate cancer

March 13, 2008

Treatment with toremifene citrate (Acapodene) appeared to reduce hot flashes in men with prostate cancer receiving androgen deprivation therapy, according to a phase III clinical trial.

Treatment with toremifene citrate (Acapodene) appeared to reduce hot flashes in men with prostate cancer receiving androgen deprivation therapy, according to a phase III clinical trial.

In an analysis of hot flashes in a subset of patients in the phase III ADT clinical trial experiencing six or more hot flashes per day at baseline and not being treated with megestrol acetate (Megace), treatment with toremifene, 80 mg, reduced the number of hot flashes by an average of 4.7 per day compared with placebo patients, who had a reduction of 1.6 hot flashes per day (p=.03). The reduction of hot flashes in patients treated with toremifene was durable for at least 12 months, researchers said.

“Hot flashes are the most common and bothersome symptomatic side effect of [androgen deprivation therapy],” said lead investigator Matthew R. Smith, MD, PhD, of Massachusetts General Hospital Cancer Center, Boston. “Up to 80% of men on ADT report being troubled by hot flashes, which are often cited as a cause of noncompliance with hormone therapy.”

The drug, which is still under investigation for this indication, had a favorable safety profile and was well tolerated. Among the most common adverse events were joint pain, dizziness, back pain, and extremity pain.