metastatic clear cell Renal Carcinoma Cell
Conditions
Brief summary
Correlation between the change in expression of PSMA expression between baseline and 6-week timepoint and the 6-month Disease Control Rate on anticancer treatment (ICI + TKI or ICI + ICI). The DCR is defined as the number of patients with o Complete response (CR), o Partial response (PR) o Stable disease (SD)) o Patients deceased or lost-of follow-up will be considered as progressive disease (PD). o Patients with a non evaluable assessment will also be categorized as non-responders.
Detailed description
o Correlation between the change in expression of PSMA on PSMA-PET/CT performed 6-weeks after anticancer treatment initiation and Objective Response Rate (ORR, defined as number of patients with CR and PR), o Correlation between baseline 68Ga-PSMA-PET expression and DCR, o Correlation between the change in expression of PSMA on PSMA PET/CT performed 6-weeks after anticancer treatment initiation and Progression-free survival (PFS) calculated as the time from the treatment start to disease progression, death, or last follow-up.
Interventions
DRUGGOZETOTIDE
Sponsors
Cliniques Universitaires Saint-Luc
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation between the change in expression of PSMA expression between baseline and 6-week timepoint and the 6-month Disease Control Rate on anticancer treatment (ICI + TKI or ICI + ICI). The DCR is defined as the number of patients with o Complete response (CR), o Partial response (PR) o Stable disease (SD)) o Patients deceased or lost-of follow-up will be considered as progressive disease (PD). o Patients with a non evaluable assessment will also be categorized as non-responders. | — |
Secondary
| Measure | Time frame |
|---|---|
| o Correlation between the change in expression of PSMA on PSMA-PET/CT performed 6-weeks after anticancer treatment initiation and Objective Response Rate (ORR, defined as number of patients with CR and PR), o Correlation between baseline 68Ga-PSMA-PET expression and DCR, o Correlation between the change in expression of PSMA on PSMA PET/CT performed 6-weeks after anticancer treatment initiation and Progression-free survival (PFS) calculated as the time from the treatment start to disease progression, death, or last follow-up. | — |
Countries
Belgium
Outcome results
None listed