Optimal Sequencing of Treatment Options for Poor Risk mCRPC Previously Treated With Docetaxel
Status:
Active, not recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
Rationale:
The aim of this study is to identify the optimal second line treatment option for patients
with a poor prognosis metastasized Castration Resistant Prostate Cancer (mCRPC) with respect
to Clinical Benefit Rate (CBR) rate and quality of life.
Objective:
The primary endpoint is CBR in mCRPC patients with poor prognostic features and previously
treated with docetaxel, randomized between cabazitaxel (Arm A) and novel hormonal agents
(abiraterone OR enzalutamide) as second-line therapy (Arm B).
Intervention:
Patients in Arm A will receive cabazitaxel and prednisone and patients in Arm B will receive
abiraterone and prednisone OR enzalutamide.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness:
Treatment regimens evaluated in this trial are used in common mCRPC treatment practice and
are reimbursed. Risk of side effects or death as a result of treatment is not affected by the
trial design. At baseline, prior to each treatment cycle and at end of treatment, patients
are requested to visit the out-patient clinic, where a physical exam will be performed in
combination with vena puncture for blood analysis. Radiological evaluation will be performed
at base line, after 3 months of treatment and at end of treatment. All above mentioned
interventions can be considered as standard practice. Patients are requested to fill out QoL
and pain/analgesic use questionnaires at base line, prior to each cycle and at end of
treatment.