Combining Docetaxel and Enzalutamide for Advanced Prostate Cancer
Docetaxel Alone or in Combination With Enzalutamide as First-line Treatment for Metastatic Castration Resistant Prostate Cancer Previously Treated With Abiraterone: a Single Center, Randomized, Open-label Study
This study is testing if combining two cancer drugs, docetaxel and enzalutamide, can help men with advanced prostate cancer live longer and feel better compared to using docetaxel alone.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Male |
| Sponsor | Zhongnan Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Wuhan, Hubei and 1 other locations) |
| Trial ID | NCT05627752 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining docetaxel with enzalutamide in patients with metastatic castrate-resistant prostate cancer (mCRPC) who have previously been treated with abiraterone. The study aims to evaluate whether this combination can improve patient outcomes compared to docetaxel alone. It is designed as a randomized controlled trial to assess the safety and efficacy of the treatment regimen. Participants will be closely monitored for radiographic progression-free survival and other clinical endpoints.
Who should consider this trial
Good fit: Ideal candidates are men diagnosed with adenocarcinoma mCRPC who have an ECOG performance status of 0-1 and have previously received abiraterone treatment.
Not a fit: Patients who have previously been treated with enzalutamide or docetaxel will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could provide a new effective option for patients with mCRPC who have limited treatment choices.
How similar studies have performed: Previous studies have shown mixed results with similar approaches, indicating the need for further investigation in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adenocarcinoma * mCRPC * Eastern Cooperative Oncology Group(ECOG) 0-1 * prior Abiraterone treatment Exclusion Criteria: * prior Enzalutamide or Docetaxel treatment
Where this trial is running
Wuhan, Hubei and 1 other locations
- Zhonghua Yang — Wuhan, Hubei, China (Recruiting)
- Zhonghua Yang — Wuhan, Hubei, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.