Trials / Terminated
TerminatedNCT02685267
Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer
A Phase II Randomized Prospective Trial of Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer (CRPC) Patients Progressing on Enzalutamide
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Prostate Cancer Clinical Trials Consortium · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective randomized phase II clinical trial where patients who are receiving enzalutamide in the pre-chemotherapy space are randomized upon objective progression (radiographic and/or clinical per PCWG2 criteria) to docetaxel/prednisone alone or the same combination plus enzalutamide. The primary aim is to evaluate whether continuing enzalutamide in combination with docetaxel in patients who failed or progressed while on enzalutamide would increase progression-free survival (PFS) by 4 months. The secondary end points are PSA responses, percent of patients alive at 1 and 2 years, decline in circulating tumor cells (CTCs), and quality of life (QOL) using validated scales.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Docetaxel | |
| DRUG | Enzalutamide | |
| DRUG | Prednisone |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2017-08-01
- Completion
- 2017-08-01
- First posted
- 2016-02-18
- Last updated
- 2021-04-09
- Results posted
- 2021-03-12
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02685267. Inclusion in this directory is not an endorsement.