Prostate CancerNCT06469710
A Trial to Evaluate the Effect of Applying Leukapheresis to Enrich CTCs in mPCa Patients
An observational study of Prostate Cancer and Circulating Tumor Cell, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer, Circulating Tumor Cell, Leukapheresis
- What is being tested?
- leukapheresis
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, Shanghai Jiao Tong University
Shanghai
Liang Dong, 13601613536
About this study
Official title: 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:
- The advantages and disadvantages of two sampling methods for further diagnosis and treatment;
- How to obtain further information on the tumour biology of CTC;
- 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
- Being tested
- leukapheresis
- Medical subject headings
- Prostatic Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leukapheresisDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of circulating tumor cells
Measurement of the number of CTCs enriched from different samples
Measured: The leukapheresis takes about 2 hours, and CTCs number will be measured in 24 hours after sampling.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start25 Jun 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Dong, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469710
- Sponsor's protocol ID
- LY2024-076-A
- Status last verified
- Aug 2026
- First submitted
- 13 Jun 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Evaluate the Effect of Applying Leukapheresis to Enrich CTCs in Patients With Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT06469710
- Acronym / sponsor ID
- LY2024-076-A
- Conditions
- Prostate Cancer, Circulating Tumor Cell, Leukapheresis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The advantages and disadvantages of two sampling methods for further diagnosis and treatment;
- How to obtain further information on the tumour biology of CTC;
- The mechanisms of prostate cancer invasion and metastasis Participants will have 7.5mL of peripheral blood taken as well as undergo leukapheresis.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| leukapheresisLeukapheresis 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. | Device | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Circulating Tumor Cell, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liang Dong (13601613536, drdongliang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of circulating tumor cells (time frame: The leukapheresis takes about 2 hours, and CTCs number will be measured in 24 hours after sampling.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.