recurrent prostate cancer
Conditions
Brief summary
complete biochemical response defined as a PSA level below limit of detection at week 60 after start of pembrolizumab.
Detailed description
radiographic progression-free survival (rPFS) at week 60 after start of pembrolizumab., PSA-nadir level and time to PSA-nadir (TTN), Pembrolizumab exposure: number of administered pembrolizumab doses, ADT: administered concomitant substances, duration, dosage (in high-risk patients only), Time to initiation of subsequent therapy (secondary ADT or novel hormonal agents [NHA]), Functional assessment of cancer therapy - Prostate: FACT-P ver. 4.0 (www.facit.org)
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
Medical Center - University Of Freiburg
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete biochemical response defined as a PSA level below limit of detection at week 60 after start of pembrolizumab. | — |
Secondary
| Measure | Time frame |
|---|---|
| radiographic progression-free survival (rPFS) at week 60 after start of pembrolizumab., PSA-nadir level and time to PSA-nadir (TTN), Pembrolizumab exposure: number of administered pembrolizumab doses, ADT: administered concomitant substances, duration, dosage (in high-risk patients only), Time to initiation of subsequent therapy (secondary ADT or novel hormonal agents [NHA]), Functional assessment of cancer therapy - Prostate: FACT-P ver. 4.0 (www.facit.org) | — |
Countries
Germany
Outcome results
None listed