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Study on the Effectiveness of Early PSMA-PET Scans with Gozetotide in Patients with Metastatic Renal Cancer Undergoing Standard Immunotherapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying metastatic clear cell renal carcinoma, a type of kidney cancer that has spread to other parts of the body. The study will use a special imaging technique called PSMA-PET scan, which involves a tracer known as 68Ga-Gozetotide. This tracer is injected into the body and helps highlight cancer cells during the scan. The purpose of the study is to evaluate how early changes in the PSMA-PET scan can predict the effectiveness of standard cancer treatments in patients with this type of kidney cancer.

Participants in the study will undergo a PSMA-PET scan early in their treatment process. This scan will be repeated six weeks after starting their cancer treatment, which may include combinations of immune checkpoint inhibitors (ICI) and tyrosine kinase inhibitors (TKI). The study aims to see if changes in the scan results can help predict how well the cancer treatment is working, as measured by the Disease Control Rate (DCR) at six months. The DCR is a measure of how many patients have a complete response, partial response, or stable disease after treatment.

The study will also look at other outcomes, such as the Objective Response Rate (ORR), which includes the number of patients with complete or partial responses, and Progression-Free Survival (PFS), which is the time from the start of treatment until the disease progresses, the patient passes away, or the last follow-up. By understanding these correlations, the study hopes to improve the prediction of treatment success in patients with metastatic clear cell renal carcinoma.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of metastatic clear cell renal carcinoma and ensuring the presence of PSMA positive lesions on a PSMA-PET/CT scan.
Eligibility criteria include being an adult over 18 years, having a histologically proven diagnosis, and being able to provide consent.
Step 2
Treatment initiation
Eligible patients begin standard immunotherapy treatment. This involves a combination of immune checkpoint inhibitors (ICI) and may include a tyrosine kinase inhibitor (TKI).
The specific combination of medications is determined based on individual patient needs and medical guidelines.
Step 3
PSMA-PET/CT scan
A PSMA-PET/CT scan is performed at the start of the treatment to establish a baseline for PSMA expression.
This scan uses a tracer highlighted by 68Ga to visualize PSMA expression in the body.
Step 4
Follow-up PSMA-PET/CT scan
A follow-up PSMA-PET/CT scan is conducted 6 weeks after the initiation of treatment.
This scan assesses changes in PSMA expression, which are used to predict the response to the anticancer treatment.
Step 5
Evaluation of treatment response
The primary goal is to evaluate the correlation between changes in PSMA expression and the Disease Control Rate (DCR) at 6 months.
DCR is defined by the number of patients with complete response, partial response, or stable disease.
Step 6
Secondary evaluations
Secondary evaluations include assessing the correlation between PSMA expression changes and the Objective Response Rate (ORR) and Progression-Free Survival (PFS).
ORR is defined by the number of patients with complete or partial response, while PFS measures the time from treatment start to disease progression or death.

Who can join the trial?

7 criteria

Adult patients over 18 years old, both male and female.
Patients must have a confirmed diagnosis of **clear cell Renal Carcinoma Cell (ccRCC)**. This is a type of kidney cancer. A **sarcomatoid component** is allowed, which means a specific type of cell change in the cancer is acceptable.
Patients must be eligible for treatment with either a combination of **ICI + ICI** or **ICI + TKI**. **ICI** stands for immune checkpoint inhibitors, which are drugs that help the immune system fight cancer. **TKI** stands for tyrosine kinase inhibitors, which are drugs that block certain proteins that help cancer cells grow.
Patients should have an expected survival of at least 6 months.
Patients must have **PSMA positive lesions** on a **PSMA-PET/CT** scan. This means that the cancer shows up on a special type of imaging test that looks for a protein called PSMA, which is often found in cancer cells.
Patients must be able to give their consent to participate in the study.
Patients must have **metastatic ccRCC**, meaning the cancer has spread to other parts of the body.

Who cannot join the trial?

3 criteria

Patients who do not have **metastatic clear cell Renal Carcinoma**. This is a type of kidney cancer that has spread to other parts of the body.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
CHU Helora
La Louviere, Belgium
Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Grand Hopital De Charleroi
Charleroi, Belgium

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Investigated drugs

PSMA-PET: This is an imaging technique used in the trial to evaluate changes in PSMA expression. It helps in predicting how well the anticancer treatment is working in patients with metastatic renal cancer. The technique involves using a special tracer, highlighted by 68Ga, to visualize cancer cells in the body through PET/CT scans.

Gozetotide

What is already known about the treatment

68Ga-PSMA – This medication is administered through an intravenous injection and is used in conjunction with PET/CT imaging. It is currently being studied in clinical trials to assess its effectiveness in predicting the response to systemic treatment in patients with metastatic clear cell renal carcinoma. The main therapeutic indication is to evaluate changes in PSMA expression, which may correlate with treatment efficacy. At the molecular level, 68Ga-PSMA binds to the Prostate-Specific Membrane Antigen (PSMA) on cancer cells, allowing for detailed imaging. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Metastatic Clear Cell Renal Carcinoma – This is a type of kidney cancer that originates in the cells lining the small tubes within the kidney. It is characterized by the spread of cancer cells from the kidney to other parts of the body, such as the lungs, bones, or liver. The disease often progresses as cancer cells grow and form new tumors in these distant organs. Symptoms may include blood in the urine, pain in the side or back, and unexplained weight loss. As the disease advances, it can lead to more severe symptoms depending on the organs affected by metastasis. The progression of the disease can vary greatly among individuals.