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

Sponsor
Zhongnan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05627752
Collaborator
(none)
120
Enrollment
2
Arms
31
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Enzalutamide 40 MG
  • Drug: Docetaxel injection
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group of Combination

Docetaxel plus Enzalutamide

Drug: Enzalutamide 40 MG
Adding Enzalutamide to Docetaxel chemotherapy

Drug: Docetaxel injection
Docetaxel chemotherapy
Placebo Comparator: Group of Docetaxel

Docetaxel plus placebo

Drug: Docetaxel injection
Docetaxel chemotherapy

Outcome Measures

Primary Outcome Measures

  1. 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

  1. overall survival (OS) [up to 16 months]

    Time from the beginning of randomization to death due to any reason.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • adenocarcinoma

  • mCRPC

  • Eastern Cooperative Oncology Group(ECOG) 0-1

  • prior Abiraterone treatment

Exclusion Criteria:
  • prior Enzalutamide or Docetaxel treatment

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Zhongnan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhongnan Hospital
ClinicalTrials.gov Identifier:
NCT05627752
Other Study ID Numbers:
  • ZhongnanH PCa
First Posted:
Nov 28, 2022
Last Update Posted:
Jan 31, 2023
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Zhongnan Hospital
chemotherapy
Enzalutamide
Abiraterone
Additional relevant MeSH terms:
Prostatic Neoplasms
Docetaxel

Study Results

No Results Posted as of Jan 31, 2023