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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
684
Risvutatug rezetecan (Ris-Rez) will be administered.
Enzalutamide will be administered.
Abiraterone will be administered.
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.
Time frame: Up to approximately 169 weeks
Overall Survival (OS)
OS is defined as the time from randomization to date of death by any cause.
Time frame: Up to approximately 169 weeks
Time to Pain Progression (TTPP)
Time frame: Up to approximately 169 weeks
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.
Time frame: Up to approximately 169 weeks
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.
Time frame: Up to approximately 169 weeks
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.
Time frame: Up to approximately 169 weeks
Time to Prostate-specific antigen (PSA) progression
Time to PSA progression is defined as the time from randomization to PSA progression according to PCWG3 criteria.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Prednisone will be administered along with Abiraterone.
Prednisolone will be administered along with Abiraterone.
Time frame: Up to approximately 169 weeks
Prostate-specific antigen 50 (PSA50) response
PSA50 is defined as the proportion of participants having a ≥50% post-baseline PSA reduction from baseline with a consecutive confirmation assessment at least 3 weeks later.
Time frame: Up to approximately 169 weeks
Time to first Symptomatic Skeletal-Related Event (SSRE)
Time to first SSRE is defined as the time from randomization to first occurrence of any of the following symptomatic skeletal-related events: * Use of EBRT to prevent or relieve skeletal symptoms . * New symptomatic pathological bone fracture (vertebral or non-vertebral). * New symptomatic spinal cord compression. * Tumor-related orthopedic surgical intervention
Time frame: Up to approximately 169 weeks
Number of participants with adverse event (AEs), serious adverse event (SAEs), Adverse event of special interest (AESIs) by severity
Time frame: Up to approximately 169 weeks
Number of participants with AEs leading to dose modifications or study intervention discontinuation
Time frame: Up to approximately 169 weeks
Serum concentration of Ris-Rez (conjugated antibody and payload)
Time frame: Up to approximately 84 days
Number of participants with Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Ris-Rez
Time frame: Up to approximately 169 weeks
Titers of ADA against Ris-Rez
Time frame: Up to approximately 169 weeks
Participant-reported experience on study treatment
Number of participants who reported their experience with study treatment using validated questionnaires will be measured
Time frame: Up to approximately 169 weeks