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

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.

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Key information

Conditions

Prostate Cancer Circulating Tumor Cell Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Leukapheresis Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

Renji Hospital, Shanghai Jiao Tong University

Shanghai, China

Location status: Recruiting

Location contact

Liang Dong

CONTACT

13601613536

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

male, aged 18-75 years; and
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;
Good general condition, ECOG score 0-1, able to tolerate leukapheresis;
Normal haematological analysis, liver and renal function tests at screening;
Subjects (or their legal representatives) can understand the informed consent form.

Exclusion criteria

those who have received systemic combination therapy for tumours within 5 years;
those with poor general condition, severe haemodynamic instability, malignant arrhythmias, cachexia and infections
those with coagulation disorders, DIC or reduced platelets;
those receiving exogenous plasma at the time of the trial;

Treatment and study plan

leukapheresis

Device

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.

Primary outcomes

Number of circulating tumor cells

Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Liang Dong

CONTACT

[email protected]

13601613536

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2028
Study completion: 2028
First posted: Jun 24, 2024
Registry last updated: Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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