A Trial to Evaluate the Effect of Applying Leukapheresis to Enrich CTCs in mPCa Patients

Launched by RENJI HOSPITAL · Jun 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called leukapheresis, which is used to collect circulating tumor cells (CTCs) from men with metastatic prostate cancer. The main goal is to compare how many CTCs can be collected using leukapheresis versus a standard blood draw. By doing this, researchers hope to learn about the pros and cons of each method, gather more information about the cancer's behavior, and understand how prostate cancer spreads in the body.

To be eligible for this study, participants need to be men aged 18 to 75 who have been diagnosed with metastatic prostate cancer, meaning the cancer has spread beyond the prostate. They should be in generally good health and able to tolerate the leukapheresis procedure, which involves taking some blood. Participants will undergo a simple blood draw of about 7.5 mL and the leukapheresis procedure. It’s important for potential participants to know that they will need to understand the details of the study and provide consent to participate. The trial is not yet recruiting, so there will be no immediate participation opportunities.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. male, aged 18-75 years; and
• • 2. Evidence of metastasis (positive finding of metastasis on one of the following tests: CT and MRI; whole-body nuclear bone imaging, fluoride PET and PET-CT, cholinergic PET-CT and MRI; prostate-specific membrane antigen-targeted PET-CT); or clinical diagnosis of metastatic prostate cancer (tumour stage of T3 and above) by pathology of aspiration/surgical biopsy;
• • 3. Good general condition, ECOG score 0-1, able to tolerate leukapheresis;
• • 4. Normal haematological analysis, liver and renal function tests at screening;
• • 5. Subjects (or their legal representatives) can understand the informed consent form.
• Exclusion Criteria:
• • 1. those who have received systemic combination therapy for tumours within 5 years;
• • 2. those with poor general condition, severe haemodynamic instability, malignant arrhythmias, cachexia and infections
• • 3. those with coagulation disorders, DIC or reduced platelets;
• • 4. those receiving exogenous plasma at the time of the trial;