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

Phase 2

Recruiting

• Conditions: Prostate Cancer; Castrate Resistant Prostate Cancer
• Interventions: Drug: Enzalutamide 40 MG; Drug: Docetaxel injection

• Registration Number: NCT05627752
• Lead Sponsor: Zhongnan Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-09
• Study First Submitted QC: 2022-11-23
• Study First Posted: 2022-11-28
• Status Verified: 2023-04
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Study Start: 2024-06-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

• prior Enzalutamide or Docetaxel treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group of Combination	Enzalutamide 40 MG	Docetaxel plus Enzalutamide
Group of Docetaxel	Docetaxel injection	Docetaxel plus placebo
Group of Combination	Docetaxel injection	Docetaxel plus Enzalutamide

Primary Outcome Measures

Name	Time	Method
progression-free survival (PFS)	up to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
overall survival (OS)	up to 16 months	Time from the beginning of randomization to death due to any reason.

Trial Locations

Locations (1)

Zhonghua Yang; 🇨🇳 Wuhan, Hubei, China