Testing Whether the Addition of Carboplatin Chemotherapy to Cabazitaxel Chemotherapy Will Improve Outcomes Compared to Cabazitaxel Alone in People With Castrate-Resistant Prostate Cancer That Has Spread Beyond the Prostate to Other Parts of the Body
NCT Number: NCT06470243
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Castration-Resistant Prostate Carcinoma|Stage IVB Prostate Cancer AJCC v8
Interventions: PROCEDURE: Biospecimen Collection|PROCEDURE: Bone Scan|DRUG: Cabazitaxel|DRUG: Carboplatin|PROCEDURE: Chest Radiography|PROCEDURE: Computed Tomography|PROCEDURE: Magnetic Resonance Imaging|PROCEDURE: Positron Emission Tomography|DRUG: Prednisone
Sponsor: SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI)
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 528
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12-12
Completion Date: 2032-04

Summary:
This phase III trial compares the effect of adding carboplatin to the standard of care chemotherapy drug cabazitaxel versus cabazitaxel alone in treating prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castrate-resistant) and that has spread from where it first started (primary site) to other places in the body (metastatic). Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Chemotherapy drugs, such as cabazitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Prednisone is often given together with chemotherapy drugs. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs and to help the chemotherapy work. Giving carboplatin with the standard of care chemotherapy drug cabazitaxel may be better at treating metastatic castrate-resistant prostate cancer.

Primary Outcome Measures: Radiographic progression-free survival (rPFS), Will be assessed using response evaluation criteria in solid tumors (RECIST 1.1), progression of bone lesions using Prostate Cancer Working Group 2 (PCWG2) criteria, or occurrence of death due to any cause. RECIST 1.1 progression requires at least a 20% increase in the sum of diameters of target lesions and/or unequivocal progression of existing non-target lesions. PCWG2 bone lesion progression requires appearance of two or more new lesions seen on bone scan compared with bone scan at randomization., From date of randomization to the first documentation of rPFS event, assessed up to 5 years
Secondary Outcome Measures: Prostate specific antigen (PSA) response, Percentage of the subset of participants with a randomization PSA level of at least 5.0 ng/ml with a greater than 50% decrease in measurable values of PSA during treatment from the value measured at randomization., From study entry to first occurrence of rPFS or clinical progression, assessed up to 5 years|Alkaline phosphatase response, Percentage of participants with a greater than 50% decrease in measurable values of alkaline phosphatase during treatment from their value at randomization., From study entry to first occurrence of rPFS or clinical progression, assessed up to 5 years|RECIST response, Percentage of the subset of participants with measurable disease with an overall objective tumor response defined as a partial response (PR) or complete response (CR) according to RECIST version 1.1., From study entry to first occurrence of rPFS or clinical progression, assessed up to 5 years|Progression-free survival, Will be descriptively characterized between the two treatment arms. Survival curves will be estimated by the Kaplan-Meier method and a log-rank test will be used to compare both overall survival (OS) and PFS between the treatment arms, stratified by aggressive variant prostate cancer - molecular-pathologic signature (AVPC-MS) status., From study entry to first occurrence of rPFS or clinical progression, assessed up to 5 years|OS, Participants known to be alive are censored at date of last contact. Will be descriptively characterized between the two treatment arms. Survival curves will be estimated by the Kaplan-Meier method and a log-rank test will be used to compare both OS and PFS between the treatment arms, stratified by AVPC-MS status., From date of randomization to date of death due to any cause, assessed up to 5 years