Multicentric trial evaluating the correlation between early PSMA-PET change and response to systemic treatment for first-line metastatic clear cell Renal Carcinoma Cell.
interventional
N/A
1 country
3
To evaluate the value of early change in the PSMA expression (highlighted by 68Ga) in the PET/CT in the prediction of anticancer treatment efficacy response in metastatic renal cancer patients, as defined by the Disease Control Rate (DCR) assessed at 6-month.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 12, 2024
Actual (reported)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.
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.
Grand Hopital De Charleroi
Charleroi, 6060, Belgium
Cliniques Universitaires Saint-Luc
Sint-Lambrechts-Woluwe, 1200, Belgium
CHU Helora
La Louviere, 7100, Belgium
Dr Emmanuel Seront
First Submitted
December 12, 2024
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