Prostate Cancer, Castrate Resistant Prostate Cancer
Conditions
Keywords
chemotherapy, Enzalutamide, Abiraterone
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.
Interventions
Adding Enzalutamide to Docetaxel chemotherapy
DRUGDocetaxel injection
Docetaxel chemotherapy
Sponsors
Zhongnan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* adenocarcinoma * mCRPC * Eastern Cooperative Oncology Group(ECOG) 0-1 * prior Abiraterone treatment
Exclusion criteria
* prior Enzalutamide or Docetaxel treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| overall survival (OS) | up to 16 months | Time from the beginning of randomization to death due to any reason. |
Countries
China
Outcome results
None listed