metastatic castration-resistant prostate cancer
Conditions
Brief summary
The main study endpoint is progression free survival, which is defined as time from randomization to radiologic, biochemical or pain progression or death from any cause, whichever occurs first, according to PCWG3 (Appendix C).
Detailed description
Overall survival, defined as time from randomization to death from any cause., Time to progression, defined as time from randomization to radiologic, biochemical or pain progression, whichever occurs first., The time to PSA progression, defined as time from randomization to biochemical progression., The time to pain progression, defined as time from randomization to pain progression., The number and severity of adverse events, Cell-free DNA aneuploidy scores and somatic aberrations in circulating tumor DNA, Differential expression of relevant genes, as measured in tissue and liquid biopsies. (comparing tissue and liquid biopsies at baseline and on-treatmen, Immune subset phenotyping and subtyping as measured in tissue and whole blood
Interventions
Sponsors
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is progression free survival, which is defined as time from randomization to radiologic, biochemical or pain progression or death from any cause, whichever occurs first, according to PCWG3 (Appendix C). | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, defined as time from randomization to death from any cause., Time to progression, defined as time from randomization to radiologic, biochemical or pain progression, whichever occurs first., The time to PSA progression, defined as time from randomization to biochemical progression., The time to pain progression, defined as time from randomization to pain progression., The number and severity of adverse events, Cell-free DNA aneuploidy scores and somatic aberrations in circulating tumor DNA, Differential expression of relevant genes, as measured in tissue and liquid biopsies. (comparing tissue and liquid biopsies at baseline and on-treatmen, Immune subset phenotyping and subtyping as measured in tissue and whole blood | — |
Countries
Netherlands
Outcome results
None listed