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A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T-cell-redirecting Agent Targeting Human Kallikrein 2, + Best Supportive Care Versus Best Supportive Care for Metastatic Castration-resistant Prostate Cancer
Status: Recruiting
The purpose of this study is to understand if a new treatment (pasritamig) added to best supportive care (including radiation, steroids, pain medication, or medications to strengthen your bones) for metastatic castration-resistant prostate cancer will work better than the best supportive care alone.
Sex: Male
Age Group: 18 years and over
Inclusion Criteria:
• diagnosis of metastatic castration-resistant prostate cancer (mCRPC): Disease is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs
• PSA greater than or equal to (>=) 2 nanogram per milliliter (ng/mL)
• at least able to walk and so all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:
• blood clot in the last month
• active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications
• significant lung disease
• another cancer
• heart disease in the past six months
• see link to clinicaltrials.gov for complete Exclusion criteria
Interventions:
Drug: Best Supportive Care (BSC), Biological: Pasritamig, Other: Placebo
Conditions:
Cancer
Keywords:
Clinics and Surgery Center (CSC), mCRPC, metastatic castration-resistant prostate cancer
Study Contact: Felicia Lin - lin00808@umn.edu
Principal Investigator: Nicholas Zorko
Phase: PHASE3
IRB Number: STUDY00026133
See this study on ClinicalTrials.gov