ClinicalTrials.gg
RecruitingNCT06469710Updated Aug 11, 2026

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

An observational study in Prostate Cancer, Circulating Tumor Cell and Leukapheresis, sponsored by RenJi Hospital. Recruiting at 1 site in China. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by RenJi Hospital · Observational

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
50
Ages
18 Years to 75 Years
Sex
Male
01

Study 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.
02

Conditions studied

  • Prostate Cancer
  • Circulating Tumor Cell
  • Leukapheresis
03

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's planned enrollment of 50 is below the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 550 studies on the registry; 247 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Male
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. male, aged 18-75 years; and
  2. Evidence of (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 ;
  3. Good general condition, 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 form.

Exclusion criteria

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 ;
  4. those receiving exogenous plasma at the time of the trial;
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • Deviceleukapheresis

    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.

06

What researchers measure

Primary outcomes

  1. Number of circulating tumor cells

    Measurement of the number of CTCs enriched from different samples

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

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06469710
Lead sponsor
RenJi Hospital
Responsible party
Liang Dong (vice president of Renji Hospital, RenJi Hospital) — Principal investigator
First posted
Jun 24, 2024
Start date
Jun 25, 2024
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Aug 11, 2026

Study contacts

Liang Dong
Contact
drdongliang@126.com
13601613536

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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