NCT06469710

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

A Trial to Evaluate the Effect of Applying Leukapheresis to Enrich CTCs in Patients With Metastatic Prostate Cancer

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-06-25
• Primary completion: 2024-07-15
• Completion: 2025-12-30
• First posted: 2024-06-24
• Last updated: 2024-06-24

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study