Enrich circulating tumor cells in metastatic prostate cancer by leukapheresis vs blood sampling

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study compares two methods of obtaining circulating tumor cells in men with metastatic prostate cancer: leukapheresis versus conventional peripheral blood collection. Participants will have both a standard blood draw and a leukapheresis procedure to measure and compare CTC counts obtained by each method. The goal is to understand the pros and cons of each sampling approach and to gather information on tumor biology through CTC analysis. Eligibility includes adult men with confirmed metastasis, good overall health status, and adequate organ function. The study is observational and does not specify an intervention beyond leukapheresis for sample enrichment.

Why it matters

Who can join: the full rules

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;

Where it's running

• Renji Hospital, Shanghai Jiao Tong University
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Liang Dong
• Email: drdongliang@126.com
• Phone: 13601613536

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.