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A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator s Choice in Participants with Chemotherapy-naïve Metastatic Castration resistant Prostate Cancer
Status: Recruiting
This research study is being done to learn more about how safe and effective the investigational drug xaluritamig is when given in combination with abiraterone acetate compared to standard care (study doctor’s choice of abiraterone acetate, docetaxel, or cabazitaxel) in people with prostate cancer that has spread to other parts of the body but has not yet been treated with chemotherapy (also known as chemotherapy naïve Metastatic Castration-Resistant Prostate Cancer [mCRPC]).
Sex: Male
Age Group: 18 years and over
Inclusion Criteria:
• diagnosis of metastatic castration-resistant prostate cancer (mCRPC)
• cancer is adenocarcinoma type
• prior orchiectomy and/or ongoing androgen-deprivation therapy (ADT)
• unable to do physically strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:
• history of central nervous system (CNS) metastases
• disease progression on or intolerance to abiraterone
• see link to clinicaltrials.gov for complete exclusion criteria
Interventions:
Drug: Abiraterone acetate, Drug: Cabazitaxel, Drug: Docetaxel, Drug: Xaluritamig
Conditions:
Cancer
Keywords:
Clinics and Surgery Center (CSC), mCRPC, Metastatic Castration-resistant Prostate Cancer
Study Contact: Nicholas Zorko - zorko004@umn.edu
Principal Investigator: Nicholas Zorko
Phase: PHASE3
IRB Number: STUDY00026650
See this study on ClinicalTrials.gov