This is a phase II clinical trial in patients with metastatic castration sensitive prostate cancer. The objective of the study is to determine the efficacy and further define the safety of the treatment combination. This study will evaluate dose levels of carboplatin AUC 4 with cabazitaxel 20 mg/m2. Patients will be treated with the combination of ADT and carboplatin and cabazitaxel for 6 cycles. After 6 cycles of chemotherapy, they will start abiraterone with ADT. The primary objective is to determine the percent of subjects that have no PSA or radiographic progression at 1 year. Secondary objectives will include determining the progression-free survival, time to PSA nadir and time to PSA progression of carboplatin and cabazitaxel in combination with ADT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
20 mg/m2 Q 21 days
AUC 4 Q21 Days x 6 cycles with ADT
1000 mg PO daily
5 mg PO daily on chemotherapy completion
Mayo Clinic Arizona
Phoenix, Arizona, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Tulane University
New Orleans, Louisiana, United States
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Thomas Jeferson University
Philadelphia, Pennsylvania, United States
Lifespan Cancer Institute
Providence, Rhode Island, United States
Prostate-Specific Antigen (PSA) or Radiographic Progression
Number of patients who have no PSA or radiographic progression as determined by RECIST 1.1 or PCWG3 criteria
Time frame: 1 Year
Progression-Free Survival (PFS)
Percentage of participants achieving Progression Free Survival
Time frame: 1 Year
PSA Nadir
Time to PSA nadir
Time frame: 1 Year
Incidence of Adverse Events
Safety and Tolerability
Time frame: 1 Year
PSA Complete Response Rate
PSA complete response rate (PSA \<=0.2 ng/mL) in patient with mutations in DNA repair genes
Time frame: 1 Year
PSA Complete Response Rate
PSA complete response rate (PSA \<=0.2 ng/ml) in patient without mutations in DNA repair genes
Time frame: 1 Year
PSA Progression
Time to PSA progression
Time frame: 1 Year
Incidence of Homologous Recombination Deficiency (HRD)
Incidence of HRD
Time frame: 1 year
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