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

June 18, 2024 updated by: Liang Dong, RenJi Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Renji Hospital, Shanghai Jiao Tong University
        • Contact:
          • Liang Dong
          • Phone Number: 13601613536

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The leukapheresis takes about 2 hours, and CTCs number will be measured in 24 hours after sampling.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 25, 2024

Primary Completion (Estimated)

July 15, 2024

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

June 13, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2024

Last Update Submitted That Met QC Criteria

June 18, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY2024-076-A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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