NCT07906717
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
StatusRecruiting
PhasePhase 3
Primary completion (estimated)
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Record History
All 2 versions: 2 with changes below.
- Notable Recruitment opened
- Trial sites expanded: 0 → 4 locations
- Start date changed from estimate of Nov 6, 2026 to Oct 29, 2026
- Study First Submitted
- Notable: the plan changed
Endpoints
Primary
Overall Survival (OS)
Timeframe: Up to 21 months
Secondary (8)
Radiographic Progression-Free Survival (rPFS)
Progression-Free Survival (PFS)
Time to Symptomatic Progression (TSP)
Time to Skeletal-Related Events (TSRE)
Time to Pain Progression (TTPP)
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Number of Participants with Treatment-Emergent Adverse Event (TEAE) by Severity
Number of Participants with Abnormalities in Clinical Laboratory Tests
Plasma Concentration of JNJ-101556143
Arms and interventions
JNJ-101556143 + Best Supportive CareExperimental
Participants will receive JNJ-101556143 orally once daily along with Best Supportive Care. Treatment will continue until discontinuation criteria are met.
Placebo + Best Supportive CarePlacebo comparator
Participants will receive matching placebo orally once daily along with Best Supportive Care. Treatment will continue until discontinuation criteria are met.
Drugs: JNJ-101556143, Placebo, Best Supportive Care
Sites
4 sites in 2 countries
United States 3, Israel 1