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

N/ANot Yet RecruitingNCT06469710

RenJi Hospital50 enrolled

Overview

The goal of this observational study is to compare the number of CTCs enriched by both sampling methods, leukapheresis and collection of peripheral blood in metastatic prostate cancer patients. The main questions it aims to answer are: 1. The advantages and disadvantages of two sampling methods for further diagnosis and treatment; 2. How to obtain further information on the tumour biology of CTC; 3. The mechanisms of prostate cancer invasion and metastasis Participants will have 7.5mL of peripheral blood taken as well as undergo leukapheresis.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Prostate Cancer Circulating Tumor Cell Leukapheresis

Interventions

leukapheresisDEVICE

Leukapheresis employs the density differential between leukocytes and other blood components to selectively separate leukocytes and return all other components of the blood to the patient. It can process multiple blood volumes in the body circulation, thereby enabling the concentration of nucleated cells to be significantly increased. The procedure is performed while maintaining no significant change in the patient's circulating blood volume, and it is a routine clinical procedure that is well tolerated and safe. CTC can be greatly enriched in a concentrated sample of leukocytes because it has a similar density to that of leukocytes and other nucleated cells. The density of CTCs is similar to that of nucleated cells, such as leukocytes, which enables their enrichment in single leukocyte concentrate samples.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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;

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts