Multicentric study evaluating the usefulness of early PSMA PET scan in metastatic renal cancer requiring standard immunotherapy treatment.
Key facts
- Where
- Charleroi, La Louvière és Sint-Lambrechts-Woluwe, BelgiumSee the 3 sites
- Phase
- 2. fázis
Where in Belgium
- Grand Hopital de CharleroiCharleroi, BelgiumTaking people
- Chu HeloraLa Louvière, BelgiumTaking people
- Cliniques Universitaires Saint-LucSint-Lambrechts-Woluwe, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cliniques Universitaires Saint-Luc
- Trial code
- EU 2024-517098-26-00
- Record updated
- 2026. február 13.
- Original description
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.Read full original descriptionShow less
Multicentric trial evaluating the correlation between early PSMA-PET change and response to systemic treatment for first-line metastatic clear cell Renal Carcinoma Cell.
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.
Inclusion: Adult patients (>18 years), male or female; Histologically proven clear cell Renal Carcinoma Cell (ccRCC). Sarcomatoid component is allowed; Patient eligible for ICI + ICI combination or ICI + TKI combination; Patient with expected survival of at least 6 months; Patients with PSMA positive lesions on PSMA-PET/CT (which is expected to be found in 90% of patients); Patients able to consent; Metastatic ccRCC.
Exclusion: Previous anticancer systemic treatment for metastatic ccRCC; Patient with active uncontrolled or symptomatic central nervous system (CNS metastases). Patients treated previously with radiotherapy and/or surgery resulting in controlled/asymptomatic CNS disease are allowed. Controlled/asymptomatic CNS disease is defined as radiological stable without evidence of progression for at least 4 weeks by repeat imaging performed prior to first dose of 68Ga-gozetotide and clinically stable without requirement of steroid treatment for at least 2 weeks prior to first dose of study treatment; Patients treated with other concomitant anticancer therapy; Patients who received prior radiotherapy within 2 weeks of the first 68Ga-gozetotide dose. Radiation-related toxicities must have resolved; Concurrent malignancy or previous malignancy in the last 3 years prior to start the study (with the exception of a history of adequately treated cervical carcinoma in situ or non-melanoma skin cancer); Patients with a hypersensitivity to the active substance of 68Ga-PSMA-11 or to one of its excipients as described in the SmPC of Locametz; Non-ccRCC; Pregnancy must be excluded and a pregnancy test must be done within 72 hours before each administration of 68Ga-gozetotide for women of childbearing potential; Breastfeeding women are excluded from the trial.