Men with prostrate cancer on androgen deprivation therapy (ADT) experienced highly statistically significant increases in bone mineral density (BMD) after one year of treatment with Acapodene (toremifene citrate).
The analysis examined BMD in the first 200 patients to complete one full year of treatment in order to give confidence that Acapodene would deliver at two years the trial’s primary endpoint, a 40% reduction in fractures. This interim analysis is the largest prospective study reported to date of osteoporosis and bone loss in men with hormone sensitive prostate cancer on ADT.
In total 1,394 participants are enrolled at 150 clinical sites in the US and Mexico in the phase III clinical trial. Patients are randomized to receive daily either an 80 mg dose of toremifene citrate or matching placebo for 24 months. The primary endpoint of the trial is the occurrence of radiographic vertebral fractures. Secondary endpoints include reduction of hot flashes and improvement in gynecomastia, lipid profiles, bone mineral density, and quality of life.
Dr Matthew Smith, an associate professor of medicine at Harvard Medical School, said: “I believe Acapodene will fill an important unmet medical need, as there are no other FDA approved treatments available to reduce fractures in men with hormone sensitive prostate cancer on ADT.”