Back to resultsDocetaxel Alone or in Combination With Enzalutamide for mCRPC Previously Treated With Abiraterone at mHSPC Stage
Primary Purpose
Prostate Cancer, Castrate Resistant Prostate Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Enzalutamide 40 MG
Docetaxel injection
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring chemotherapy, Enzalutamide, Abiraterone
Eligibility Criteria
Inclusion Criteria: adenocarcinoma mCRPC Eastern Cooperative Oncology Group(ECOG) 0-1 prior Abiraterone treatment Exclusion Criteria: prior Enzalutamide or Docetaxel treatment
Sites / Locations
- Zhonghua YangRecruiting
- Zhonghua YangRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group of Combination
Group of Docetaxel
Arm Description
Docetaxel plus Enzalutamide
Docetaxel plus placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
overall survival (OS)
Time from the beginning of randomization to death due to any reason.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05627752
Brief Title
Docetaxel Alone or in Combination With Enzalutamide for mCRPC Previously Treated With Abiraterone at mHSPC Stage
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongnan Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Castrate Resistant Prostate Cancer
Keywords
chemotherapy, Enzalutamide, Abiraterone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group of Combination
Arm Type
Experimental
Arm Description
Docetaxel plus Enzalutamide
Arm Title
Group of Docetaxel
Arm Type
Placebo Comparator
Arm Description
Docetaxel plus placebo
Intervention Type
Drug
Intervention Name(s)
Enzalutamide 40 MG
Intervention Description
Adding Enzalutamide to Docetaxel chemotherapy
Intervention Type
Drug
Intervention Name(s)
Docetaxel injection
Intervention Description
Docetaxel chemotherapy
Primary Outcome Measure Information:
Title
progression-free survival (PFS)
Description
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.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
overall survival (OS)
Description
Time from the beginning of randomization to death due to any reason.
Time Frame
up to 16 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adenocarcinoma
mCRPC
Eastern Cooperative Oncology Group(ECOG) 0-1
prior Abiraterone treatment
Exclusion Criteria:
prior Enzalutamide or Docetaxel treatment
Facility Information:
Facility Name
Zhonghua Yang
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhonghua Yang, Dr.
Phone
86 18071118052
Email
yangzhonghua@whu.edu.cn
Facility Name
Zhonghua Yang
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhonghua Yang, Dr.
Phone
18071118052
Email
yangzhonghua@whu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Docetaxel Alone or in Combination With Enzalutamide for mCRPC Previously Treated With Abiraterone at mHSPC Stage
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