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

NCT06469710 | Not Yet Recruiting FDA Device

• 1 other identifier: LY2024-076-A
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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. 1.The advantages and disadvantages of two sampling methods for further diagnosis and treatment;
2. 2.How to obtain further information on the tumour biology of CTC;
3. 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

Outcome Measures

Primary Outcomes (1)

• Number of circulating tumor cells

  Measurement of the number of CTCs enriched from different samples

  The leukapheresis takes about 2 hours, and CTCs number will be measured in 24 hours after sampling.

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic prostate cancer with the following specific subject recruitment criteria: 1. Clinical diagnosis of metastatic prostate cancer with tumour stage of T3 or above; 2. Metastatic signs on relevant imaging tests, including CT and MRI, whole-body nuclear bone imaging, fluoride PET and PET-CT, cholinergic PET-CT and MRI, and prostate specific membrane antigen (PSMA)-targeted PET-CT; 3. After radical prostatectomy for prostate cancer with indication of biochemical recurrence (PSA\>0.2ng/mL); 4. Those with metastatic prostate cancer diagnosed by puncture or postoperative pathology; 5. Previous medical history and treatment history.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University

Shanghai, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplastic Cells, Circulating

Interventions

Leukapheresis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques

Central Study Contacts

Liang Dong

CONTACT

13601613536; drdongliang@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president of Renji Hospital

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 24, 2024
• Study Start: June 25, 2024
• Primary Completion: July 15, 2024
• Study Completion: December 30, 2025
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

CN (1)