Docetaxel Alone or in Combination With Enzalutamide for mCRPC Previously Treated With Abiraterone at mHSPC Stage
1 other identifier
interventional
120
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Jun 2024
Shorter than P25 for phase_2 prostate-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2022
CompletedFirst Posted
Study publicly available on registry
November 28, 2022
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedFebruary 28, 2024
April 1, 2023
1.6 years
October 9, 2022
February 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
overall survival (OS)
up to 16 months
Study Arms (2)
Group of Combination
EXPERIMENTALDocetaxel plus Enzalutamide
Group of Docetaxel
PLACEBO COMPARATORDocetaxel plus placebo
Interventions
Eligibility Criteria
You may qualify if:
- adenocarcinoma
- mCRPC
- Eastern Cooperative Oncology Group(ECOG) 0-1
- prior Abiraterone treatment
You may not qualify if:
- prior Enzalutamide or Docetaxel treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Zhonghua Yang
Wuhan, Hubei, 430071, China
Zhonghua Yang
Wuhan, Hubei, 430071, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2022
First Posted
November 28, 2022
Study Start
June 1, 2024
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
February 28, 2024
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL