Biochemically recurrent prostate cancer
Conditions
Brief summary
rPFS by PSMA PET/CT assessed by BICR
Detailed description
MFS by CI assessed by BICR, Time to CRPC, Time to initiation of first subsequent systemic antineoplastic therapy, Time to loco-regional progression by PSMA PET/CT, Time to first SSE, OS, PSA undetectable rates (<0.2 ng/mL) at 12 months, Time to deterioration in the FACT-P total score, Number of participants with TEAEs and TESAEs categorized by severity, Number of participants who discontinue study treatment due to a TEAE, Time to symptomatic progression
Interventions
Sponsors
Bayer Consumer Care AG, Bayer AG
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rPFS by PSMA PET/CT assessed by BICR | — |
Secondary
| Measure | Time frame |
|---|---|
| MFS by CI assessed by BICR, Time to CRPC, Time to initiation of first subsequent systemic antineoplastic therapy, Time to loco-regional progression by PSMA PET/CT, Time to first SSE, OS, PSA undetectable rates (<0.2 ng/mL) at 12 months, Time to deterioration in the FACT-P total score, Number of participants with TEAEs and TESAEs categorized by severity, Number of participants who discontinue study treatment due to a TEAE, Time to symptomatic progression | — |
Countries
Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Spain, Sweden
Outcome results
None listed