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Trial Title:
Docetaxel Alone or in Combination With Enzalutamide for mCRPC Previously Treated With Abiraterone at mHSPC Stage
NCT ID:
NCT05627752
Condition:
Prostate Cancer
Castrate Resistant Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Docetaxel
Conditions: Keywords:
chemotherapy
Enzalutamide
Abiraterone
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Enzalutamide 40 MG
Description:
Adding Enzalutamide to Docetaxel chemotherapy
Arm group label:
Group of Combination
Intervention type:
Drug
Intervention name:
Docetaxel injection
Description:
Docetaxel chemotherapy
Arm group label:
Group of Combination
Arm group label:
Group of Docetaxel
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- adenocarcinoma
- mCRPC
- Eastern Cooperative Oncology Group(ECOG) 0-1
- prior Abiraterone treatment
Exclusion Criteria:
- prior Enzalutamide or Docetaxel treatment
Gender:
Male
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhonghua Yang
Address:
City:
Wuhan
Zip:
430071
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhonghua Yang, Dr.
Phone:
86 18071118052
Email:
yangzhonghua@whu.edu.cn
Facility:
Name:
Zhonghua Yang
Address:
City:
Wuhan
Zip:
430071
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhonghua Yang, Dr.
Phone:
18071118052
Email:
yangzhonghua@whu.edu.cn
Start date:
June 1, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Zhongnan Hospital
Agency class:
Other
Source:
Zhongnan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05627752
