metastatic castration-resistant prostate cancer
Conditions
Brief summary
PFS defined as time from randomization to biochemical, clinical, or radiographic progression, or death from any cause, whichever occurs first., QoL until progression measured using the German version of the FACIT-F scale
Detailed description
50% PSA response (PSA50) defined as a PSA decrease of ≥ 50% at any time compared to baseline value, Percentage of change in PSA from baseline to 12 weeks, Maximum decline in PSA that occurs at any point after start of treatment, Symptomatic progression-free survival defined as time from randomization to clinical progression or death from any cause, whichever occurs first., Overall Survival (OS) defined as time from randomization to death from any cause
Interventions
DRUGTestogel Dosiergel 16
DRUG2 mg/g Gel
DRUGBAY 1841788
DRUGABIRATERONE
DRUGDOCETAXEL
DRUGCABAZITAXEL
DRUGENZALUTAMIDE
Sponsors
Universitaet Muenster
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS defined as time from randomization to biochemical, clinical, or radiographic progression, or death from any cause, whichever occurs first., QoL until progression measured using the German version of the FACIT-F scale | — |
Secondary
| Measure | Time frame |
|---|---|
| 50% PSA response (PSA50) defined as a PSA decrease of ≥ 50% at any time compared to baseline value, Percentage of change in PSA from baseline to 12 weeks, Maximum decline in PSA that occurs at any point after start of treatment, Symptomatic progression-free survival defined as time from randomization to clinical progression or death from any cause, whichever occurs first., Overall Survival (OS) defined as time from randomization to death from any cause | — |
Countries
Germany
Outcome results
None listed