A total of 75 participants will be enrolled in the study, with 25 participants allocated per intervention group. In Group 1, participant will take 50 mg cabazitaxel every week for 6 cycles (3 doses per cycle), 10 mg prednisone daily till the end of cycle 6. In Group 2, participant will take 100 mg cabazitaxel every week for 6 cycles (3 doses per cycle), 10 mg prednisone daily till the end of cycle 6. In Group 3, participant will take 200 mg cabazitaxel every 3 weeks for 6 cycles (1 doses per cycle), 10 mg prednisone daily till the end of cycle 6.
The study comprises three phases: a 21-day screening phase, an 18-week intervention phase starting on Day 1 (baseline), and a post-intervention follow-up phase lasting up to 12 months from Day 1. The total duration of participation for each individual will be approximately one year.
Key efficacy assessments include CT scans/MRI, bone scans, PSA, ALP, LDH, symptomatic skeletal events, and pain evaluations. Key safety assessments encompass the monitoring of adverse events (AEs), ECOG performance status, physical examinations, vital sign measurements, clinical laboratory tests, peripheral neuropathy evaluation, 12-lead ECG, and echocardiogram (ECHO) assessments.
Pharmacokinetic parameters will also be evaluated.
Must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study.
Male participant ≥18 years of age at the time of signing the informed consent.
Participant must have histological pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
Evidence of metastatic disease.
Known allergies, hypersensitivity, or intolerance to any of the study interventions, or components/ excipients thereof (refer to the IB), or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study.
Contraindications to the use of prednisone or medical ADT per locally approved prescribing information.
Previous treatment with cabazitaxel in any setting.
Had major surgical procedure or significant traumatic injury requiring general anaesthesia within 4 weeks or will not have fully recovered from surgical procedure prior to first dose of the study intervention; or has surgical procedure planned during the time the participant is expected to participate in the study.