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Prosper: A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled, Efficacy And Safety Study Of Enzalutamide in Patients With Non-metastatic Castration-resistant Prostate Cancer
Primary Objective:
The primary objective is to determine the efficacy of enzalutamide compared with placebo as
assessed by MFS.
Secondary Objectives:
To evaluate the benefit of enzalutamide compared with placebo as measured by the
following:
Overall survival;
Time to pain progression;
Time to opiate use for prostate cancer pain;
Time to pain progression or opiate use for prostate cancer pain;
Time to first use of cytotoxic chemotherapy;
Time to first use of new antineoplastic therapy;
Time to PSA progression;
PSA response rates;
Time to functional status deterioration as assessed by the Functional Assessment
of Cancer Therapy-Prostate (FACT-P) global score;
Quality of life as assessed by the European Quality of
Life-5 Dimensions-5 Levels (EQ-5D-5L) health questionnaire and Quality of Life
Questionnaire-Prostate 25 (QLQ-PR25) module.
To evaluate safety.
Primary Objective:
The primary objective is to determine the efficacy of enzalutamide compared with placebo as
assessed by MFS.
Secondary Objectives:
To evaluate the benefit of enzalutamide compared with placebo as measured by the
following:
Overall survival;
Time to pain progression;
Time to opiate use for prostate cancer pain;
Time to pain progression or opiate use for prostate cancer pain;
Time to first use of cytotoxic chemotherapy;
Time to first use of new antineoplastic therapy;
Time to PSA progression;
PSA response rates;
Time to functional status deterioration as assessed by the Functional Assessment
of Cancer Therapy-Prostate (FACT-P) global score;
Quality of life as assessed by the European Quality of
Life-5 Dimensions-5 Levels (EQ-5D-5L) health questionnaire and Quality of Life
Questionnaire-Prostate 25 (QLQ-PR25) module.
To evaluate safety.
Recruitment Status
Past Studies