Docetaxel Alone or in Combination With Enzalutamide for mCRPC Previously Treated With Abiraterone at mHSPC Stage

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05627752
• Other study ID #: ZhongnanH PCa
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: Zhongnan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

New androgen pathway targeting agents (ARTA), including Abiraterone acetate, Apalutamide and Enzalutamide, are approved and used in treatment of metastatic hormonal sensitive prostate cancer(mHSPC). However, the development of castration-resistance prostate cancer(CRPC) is only a matter of time. The use of sequential ARTAs in mCRPC showed limited benefit in retrospective series and prospective trials. Therefore this sequence should be avoided because of known cross resistance and the availability of chemotherapy and poly adenosine diphosphate-ribose polymerase(PARP) inhibitors (if a relevant mutation is present). Recently, a randomized controlled trial(RCT), the ABIDO-SOGUG, indicated that compared with docetaxel, maintaining Abiraterone added to docetaxel in chemotherapy-naive patients who have experienced cancer progression to Abiraterone treatment could not improve radiographic progression-free survival or the other endpoints.However, another RCT, the PRESIDE trial, indicated that in patients who had progressed on Enzalutamide, continued Enzalutamide treatment in combination with docetaxel led to a significant improvement of PFS compared with placebo plus docetaxel. The aims of this trial is to assess both the efficacy and safety of docetaxel in combination with Enzalutamide as first-line treatment in mCRPC patients progressed on Abiraterone.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• adenocarcinoma
• mCRPC
• Eastern Cooperative Oncology Group(ECOG) 0-1
• prior Abiraterone treatment

Exclusion Criteria:

• prior Enzalutamide or Docetaxel treatment

Related Conditions & MeSH terms

• Castrate Resistant Prostate Cancer
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Enzalutamide 40 MG
Adding Enzalutamide to Docetaxel chemotherapy
• Docetaxel injection
Docetaxel chemotherapy

Locations

Country	Name	City	State
China	Zhonghua Yang	Wuhan	Hubei
China	Zhonghua Yang	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival (PFS)	The time from the beginning of randomization to the first disease progression (that is, biochemical progression, tumor growth, or the discovery of new lesions) or death due to any reason.	up to 6 months
Secondary	overall survival (OS)	Time from the beginning of randomization to death due to any reason.	up to 16 months