A Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone

Summary

Participation Requirements

Description

The study will be conducted in consecutive periods of open label treatment with enzalutamide followed by randomized double-blind treatment with continued enzalutamide or placebo, in combination with docetaxel and prednisolone. Open Label (Period 1) Participants will receive open label treatment with...

The study will be conducted in consecutive periods of open label treatment with enzalutamide followed by randomized double-blind treatment with continued enzalutamide or placebo, in combination with docetaxel and prednisolone. Open Label (Period 1) Participants will receive open label treatment with enzalutamide. At week 13, all participants will be assessed by prostate-specific antigen (PSA) and imaging. Participants with no confirmed PSA response or evidence of radiographic progression will be ineligible for participation in Period 2 and will typically have safety follow up; however, Period 1 treatment may continue for some participants as long as the investigator considers it to be of clinical benefit (stopping on initiation of any new antineoplastic therapy). Participants with confirmed PSA response will continue Period 1 until disease progression. Enrollment to Period 2 will cease after approximately 274 participants have been enrolled or 182 primary endpoint events have been reached, whichever occurs first. Participants who are not randomized into period 2 at this time may continue receiving open label treatment in an extension period. Randomization (Double Blind) (Period 2) Participants with confirmed disease progression on enzalutamide alone who continue to meet all eligibility criteria may proceed to randomization. Treatment allocation will be in a 1:1 ratio, stratified by disease progression in Period 1 to the following treatments: Enzalutamide with docetaxel and prednisolone Placebo with docetaxel and prednisolone Any ongoing participants in Period 2 at the point of unblinding in the enzalutamide+docetaxel arm that are still receiving and benefitting from enzalutamide treatment , will have the option to continue treatment via an extension period.

Tracking Information