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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prostate Cancer, Castrate Resistant Prostate Cancer

Intervention / Treatment
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* Drug: Enzalutamide 40 MG
* Drug: Docetaxel injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adenocarcinoma mCRPC Eastern Cooperative Oncology Group(ECOG) 0-1 prior Abiraterone treatment Exclusion Criteria: prior Enzalutamide or Docetaxel treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group of Combination<br>Docetaxel plus Enzalutamide | Drug: Enzalutamide 40 MG<br>* Adding Enzalutamide to Docetaxel chemotherapy<br>Drug: Docetaxel injection<br>* Docetaxel chemotherapy<br>|
| Placebo Comparator: Group of Docetaxel<br>Docetaxel plus placebo | Drug: Docetaxel injection<br>* Docetaxel chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) | Time from the beginning of randomization to death due to any reason. | up to 16 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy, Enzalutamide, Abiraterone