This study aims to evaluate how well risvutatug rezetecan (Ris-Rez) works in treating prostate cancer compared to best supportive/standard of care (BSC) which may include a hormone therapy with an androgen receptor pathway inhibitors (ARPI), by checking whether it makes cancers smaller or disappear completely, if it helps participants live longer, and/or feel better. The study is also assessing whether Ris-Rez is safe and tolerated well by participants and aims to provide a better understanding of the side effects of the drug.
Participants ≥18 years of age
Has histologically or cytologically confirmed adenocarcinoma of the prostate.
Has an Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1, with no deterioration in the 2 weeks before randomization.
Has a life expectancy of at least 4 months.
Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, mixed histologies or any histology different from adenocarcinoma.
Participants with known mismatch repair deficient (dMMR)/MSI-H/TMB-H status and eligible for immune checkpoint inhibitor therapy,
Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix] with no evidence of metastatic disease.
Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization,
Parallel
Risvutatug rezetecan (Ris-Rez)
Biological/VaccineRisvutatug rezetecan (Ris-Rez) will be administered.
Enzalutamide
DrugEnzalutamide will be administered.
Abiraterone
DrugAbiraterone will be administered.
Prednisone
DrugPrednisone will be administered along with Abiraterone.
Prednisolone
DrugPrednisolone will be administered along with Abiraterone.
Radiographic Progression-Free Survival (rPFS) per PCWG3 by BICR
rPFS is defined as time from randomization to the first documented radiographic disease progression, per Prostate cancer clinical trials working group 3 (PCWG3) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first.
Overall Survival (OS)
OS is defined as the time from randomization to date of death by any cause.
Time to Pain Progression (TTPP)
rPFS by Investigator assessment
rPFS is defined as time from randomization to the first documented radiographic disease progression per PCWG3 as assessed by Investigator or death due to any cause, whichever occurs first.
Confirmed Objective Response Rate (cORR)
cORR is defined as the percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) per PCWG3 by BICR.
Duration of Response (DoR)
DoR defined as the time from the date of first confirmed response (CR or PR) to the date of first documented PD per PCWG3 as assessed by BICR or death due to any cause, whichever comes first.
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