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

Zhongnan Hospital

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Prostate Cancer; Castrate Resistant Prostate Cancer

Treatments: Drug: Enzalutamide 40 MG; Drug: Docetaxel injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05627752

ZhongnanH PCa

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• prior Enzalutamide or Docetaxel treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

Group of Combination

Experimental group

Description:

Docetaxel plus Enzalutamide

Treatment:

Drug: Docetaxel injection

Drug: Enzalutamide 40 MG

Group of Docetaxel

Placebo Comparator group

Description:

Docetaxel plus placebo

Treatment:

Drug: Docetaxel injection