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

Not yet recruiting

• Conditions: Circulating Tumor Cell; Leukapheresis; Prostate Cancer

• Registration Number: NCT06469710
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-06-18
• Last Update Submitted: 2024-06-18
• Study First Posted: 2024-06-24
• Last Update Posted: 2024-06-24
• Study Start: 2024-06-25
• Primary Completion: 2024-07-15
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 50

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of circulating tumor cells	The leukapheresis takes about 2 hours, and CTCs number will be measured in 24 hours after sampling.	Measurement of the number of CTCs enriched from different samples

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiao Tong University; 🇨🇳 Shanghai, China