Primary Objective: To demonstrate the superiority in term of radiographic Progression-Free Survival (rPFS) of cabazitaxel at at 25 milligram per meter square (mg/m\^2) plus prednisone (Arm A) versus either enzalutamide at 160 milligram (mg) once daily or abiraterone acetate at 1000 mg once daily plus prednisone (Arm B) in chemotherapy-naïve participants with metastatic Castration-Resistant Prostate Cancer (mCRPC) who have disease progression while receiving androgen receptor (AR) targeted therapy (abiraterone plus prednisone or enzalutamide) within 12 months of treatment initiation (≤12 months). Secondary Objective: * To compare efficacy for: * Prostate-specific antigen (PSA) response rate and Time to PSA progression (TTPP). * Progression Free Survival (PFS). * Overall Survival (OS). * Tumor response rate in participants with measurable disease (RECIST 1.1) * Pain response and time to pain progression. * Symptomatic skeletal events (SSE) rate and time to occurrence of any SSE. * To analyze messenger ribonucleic acids (mRNAs) including androgen-receptor splice variant 7 messenger RNA (AR-V7) as a biomarker in Circulating Tumor Cells (CTCs). * To evaluate safety in the 2 treatment arms.
The duration of the study per participant was approximately 2 years. Each participant was treated until radiographic disease progression, unacceptable toxicity, or participants refusal of further study treatment, and each participant was followed after completion of study treatment until death, study cutoff date, or withdrawal of participant consent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Investigational Site Number 840030
Muscle Shoals, Alabama, United States
Investigational Site Number 840024
Anchorage, Alaska, United States
Investigational Site Number 840028
Anaheim, California, United States
Investigational Site Number 840004
Sacramento, California, United States
Investigational Site Number 840002
Boca Raton, Florida, United States
Investigational Site Number 840027
Lakeland, Florida, United States
Investigational Site Number 840006
Port Saint Lucie, Florida, United States
Investigational Site Number 840015
Ottawa, Illinois, United States
Investigational Site Number 840001
Covington, Louisiana, United States
Investigational Site Number 840017
Metairie, Louisiana, United States
...and 14 more locations
Radiographic Progression-Free Survival (rPFS)
rPFS was defined as the time from randomization to the first occurrence of radiological tumor progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or progression of bone lesions using prostate cancer working group 2 (PCWG2) criteria or death due to any cause.
Time frame: Baseline until tumor progression or bone lesion progression or death due to any cause (maximum duration: 1059 days)
Number of Participants With Prostate Specific Antigen (PSA) Response
PSA response was defined as decline of serum PSA from baseline by \>= 50 percent (%).
Time frame: Baseline up to PSA progression or death due to any cause (maximum duration: 1059 days)
Progression-free Survival (PFS)
PFS: time interval between date of randomization to first documentation of tumor progression as per RECIST 1.1.
Time frame: Baseline upto progression or death due to any cause (maximum duration: 1059 days)
Overall Survival
Overall Survival was defined as the time interval from the date of randomization to the date of death due to any cause.
Time frame: Baseline until death or study cut-off date, whichever was earlier (maximum duration: 1059 days)
Time to PSA Progression
Time to PSA progression was defined as the time interval between the date of randomization and the date of first documented PSA progression as per PCWG2 criteria.
Time frame: Baseline up to PSA progression or death due to any cause (maximum duration: 1059 days)
Number of Participants Achieving Tumor Response
Tumor response was defined as either a partial response (PR) or complete response (CR) according to the RECIST 1.1.
Time frame: Baseline up to disease progression or death due to any cause (maximum duration: 1059 days)
Duration of Tumor Response
Duration of tumor response was defined as the time between the first evaluation at which the tumor response criteria were met and the first documentation of tumor progression.
Time frame: Baseline up to disease progression or death due to any cause (maximum duration: 1059 days)
Pain Response Using Brief Pain Inventory-Short Form (BPI-SF) for Pain Intensity Score
Pain response was analyzed using the brief pain inventory-short form (BPI-SF).
Time frame: Baseline until the end of study (maximum duration: 1059 days)
Time to Pain Progression
Time to pain progression was defined as the time interval between the date of randomization and the date of the first documented pain progression.
Time frame: Baseline until disease progression, start of another anticancer therapy or study cut off, whichever came first (maximum duration: 1059 days)
Percentage of Participants With Symptomatic Skeletal Event (SSE)
SSE was the occurrence of a new symptomatic pathological fracture, or the use of external beam radiation to relieve bone pain, or the occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention.
Time frame: Baseline until the end of study (maximum duration: 1059 days)
Time to Occurrence of Any Symptomatic Skeletal Events (SSE)
Time to SSE was defined as the time interval between the date of randomization and the date of the occurrence of the first event defining a SSE, whichever is earlier.
Time frame: Baseline up to occurrence of the first event defining a SSE (maximum duration: 1059 days)
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