Docetaxel Alone or in Combination With Enzalutamide for mCRPC Previously Treated With Abiraterone at mHSPC Stage
NCT ID: NCT05627752
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2024-06-01
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group of Combination
Docetaxel plus Enzalutamide
Enzalutamide 40 MG
Adding Enzalutamide to Docetaxel chemotherapy
Docetaxel injection
Docetaxel chemotherapy
Group of Docetaxel
Docetaxel plus placebo
Docetaxel injection
Docetaxel chemotherapy
Interventions
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Enzalutamide 40 MG
Adding Enzalutamide to Docetaxel chemotherapy
Docetaxel injection
Docetaxel chemotherapy
Eligibility Criteria
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Inclusion Criteria
* mCRPC
* Eastern Cooperative Oncology Group(ECOG) 0-1
* prior Abiraterone treatment
Exclusion Criteria
18 Years
75 Years
MALE
No
Sponsors
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Zhongnan Hospital
OTHER
Responsible Party
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Locations
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Zhonghua Yang
Wuhan, Hubei, China
Zhonghua Yang
Wuhan, Hubei, China
Countries
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Facility Contacts
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Other Identifiers
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ZhongnanH PCa
Identifier Type: -
Identifier Source: org_study_id
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