Global Phase III trial of enzalutamide in progressive, high-risk prostate cancer

According to a joint media release from Medivation and Astellas earlier today, the companies will soon be initiating an important and major new trial of enzalutamide in men with progressive prostate cancer after first-line therapy.

According to the media release, the intent is to conduct a three-arm, randomized, multi-national, Phase III clinical trial at about 160 sites around the world. The trial will be designed to evaluate the efficacy and safety of enzalutamide in patients with high-risk, hormone-sensitive, non-metastatic prostate cancer that has biochemically recurred (with a rising PSA) following definitive local therapy with radical prostatectomy and/or radiation therapy.

The trial is designed to enroll approximately 1,860 hormone-sensitive, non-metastatic patients who are at high risk for morbidity and mortality from prostate cancer. Such patients will be randomized two treatment in one of three separate treatment groups:

  • Enzalutamide (160 mg once daily) alone
  • Enzalutamide (160 mg once daily) + leuprolide acetate (22.5 mg once every 12 weeks for a minimum of 3 doses)
  • Placebo plus leuprolide acetate (22.5 mg once every 12 weeks for a minimum of 3 doses)

Treatment with enzalutamide monotherapy will be open-label. Treatment with enzalutamide and with placebo will be double-blind in combination with open-label leuprolide acetate. All patients will be treated for 37 weeks.

Patients who achieve an undetectable PSA level after 37 weeks will have all study drugs suspended. In such patients, if and when the PSA rises again, the original study drug(s) will be restarted. Study drug treatment will then continue until disease progression.

The “New” Prostate Cancer InfoLink is very pleased to see this trial being initiated. It is similar to a trial conducted many years ago now that had led to high-dose bicalutamide (Casodex) being approved as an early treatment for men with high-risk, progressive prostate cancer in Europe (but not in the USA where the FDA concluded that the side effects associated with treatment presented patients with too much risk in light of the limited clinical benefit).

At present it is not clear exactly when this trial will start to enroll patients, and there is no information about the trial on the web site. Hopefully, we will see the trial actually initiated at least by early next year.

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