NCT03246347

A Trial of Androgen Deprivation, Docetaxel, and Enzalutamide for Metastatic Prostate Cancer

A Phase II Trial of Androgen Deprivation, Docetaxel and Enzalutamide in Patients With Metastatic Hormone Sensitive Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study with the combination of androgen deprivation therapy (ADT) and docetaxel with the addition of enzalutamide in the treatment of subjects with metastatic prostate cancer. The purpose of this study is to assess if ADT + docetaxel + enzalutamide is well tolerated and demonstrates improved efficacy compared to ADT + docetaxel.

Detailed description

This is a single center, single arm, phase II trial designed to evaluate the 12 month PSA complete response rate in patients with metastatic hormone sensitive prostate cancer treated with ADT, docetaxel and enzalutamide. The primary endpoint of this study will be 12-month PSA complete response rate, which will be assessed against a contemporary historical control rate for the combination of ADT and docetaxel alone in the metastatic hormone naive setting. The study will be conducted at all participating sites across North and South Carolina within the Levine Cancer Institute network. Enrollment is anticipated to be completed within 24 months.

Conditions

• Prostate Cancer
• Prostate Adenocarcinoma

Interventions

Type	Name	Description
DRUG	ADT+Docetaxel+Enzalutamide	combination therapy as listed above

Timeline

• Start date: 2017-08-23
• Primary completion: 2022-09-01
• Completion: 2028-03-01
• First posted: 2017-08-11
• Last updated: 2026-01-23
• Results posted: 2023-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study