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

NCT ID: NCT06469710

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-25
• Study Completion Date: 2025-12-30

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.

Conditions

Prostate Cancer; Circulating Tumor Cell; Leukapheresis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Interventions

leukapheresis

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.

Intervention Type: DEVICE

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Liang Dong

vice president of Renji Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Renji Hospital, Shanghai Jiao Tong University

Shanghai, , China

Countries

China

Central Contacts

Liang Dong

Role: CONTACT

drdongliang@126.com

13601613536

Facility Contacts

Liang Dong

Role: primary

13601613536

Other Identifiers

LY2024-076-A

Identifier Type: -

Identifier Source: org_study_id