NCT02213107

Enzalutamide & Dutasteride/Finasteride as 1st Line Treatment for Patients =/> 65 Years Old With Prostate Cancer.

A Phase II Study of Enzalutamide Plus Dutasteride/Finasteride as First Line Treatment for Vulnerable Patients ≥ 65 Years With Systemic Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 65 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Determine the effect of enzalutamide and dutasteride or finasteride on the time to prostatic-specific antigen level increase in patients age 65 or older.

Detailed description

The primary objective of this study is to determine the effect of enzalutamide and dutasteride or finasteride on the time to prostatic-specific antigen progression in patients aged 65 or older receiving this combination as first line treatment for systemic prostate cancer. To determine the safety and toxicities of the study drug combination. To determine the time to prostatic-specific antigen nadir from the start of study treatment and to evaluate the absolute prostatic-specific antigen nadir as a result of the study drug combination

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Enzalutamide and Dutasteride or finasteride	Use of either two oral drugs together 1. Enzalutamide by mouth daily and dutasteride by mouth daily or 2. Enzalutamide by mouth daily and finasteride by mouth daily

Timeline

• Start date: 2014-09-01
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2014-08-11
• Last updated: 2024-11-13
• Results posted: 2024-11-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study