High-risk localized or locally advanced prostate cancer
Conditions
Brief summary
pCR rate (as defined in the pathology charter and assessed by a pathology blinded independent central review [BICR]), MFS based on conventional or PSMA PET imaging (defined as the time from randomization to the date of the first occurrence of radiographic distant metastasis on conventional [ie, CT/MRI and bone scan] or PSMA PET imaging evaluated by radiology BICR, pathologic finding of distant metastasis, or death from any cause, whichever occurs first).
Interventions
Sponsors
Janssen - Cilag International
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR rate (as defined in the pathology charter and assessed by a pathology blinded independent central review [BICR]), MFS based on conventional or PSMA PET imaging (defined as the time from randomization to the date of the first occurrence of radiographic distant metastasis on conventional [ie, CT/MRI and bone scan] or PSMA PET imaging evaluated by radiology BICR, pathologic finding of distant metastasis, or death from any cause, whichever occurs first). | — |
Countries
Czechia, France, Germany, Italy, Netherlands, Poland, Spain
Outcome results
None listed