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

February 27, 2024 updated by: Zhongnan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430071

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • prior Enzalutamide or Docetaxel treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival (PFS)
Time Frame: 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.
up to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongnan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 9, 2022

First Submitted That Met QC Criteria

November 23, 2022

First Posted (Actual)

November 28, 2022

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZhongnanH PCa

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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