C3431004/MDV3100-13: A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513521-23-00

Acronym

C3431004/MDV3100-13

Enrollment

366

Registered

2024-07-19

Start date

2015-08-19

Completion date

Unknown

Last updated

2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief summary

To evaluate efficacy of the combination of enzalutamide plus leuprolide versus placebo plus leuprolide, as measured by MFS.

Detailed description

Time to PSA progression: Time to first use of new antineoplastic therapy; Overall survival., To evaluate efficacy, as measured by MFS between enzalutamide monotherapy versus placebo plus leuprolide.

Interventions

DRUGLEUPRORELIN ACETATE

DRUGXtandi - 40 mg soft capsules

DRUGPlacebo for Enzalutamide 40 mg soft gelatin capsule

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To evaluate efficacy of the combination of enzalutamide plus leuprolide versus placebo plus leuprolide, as measured by MFS.	—

Secondary

Measure	Time frame
Time to PSA progression: Time to first use of new antineoplastic therapy; Overall survival., To evaluate efficacy, as measured by MFS between enzalutamide monotherapy versus placebo plus leuprolide.	—

Countries

Austria, Denmark, Finland, France, Italy, Netherlands, Poland, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026