Clinical trial NCT06469710: A Trial to Evaluate the Effect of Applying Leukapheresis to Enrich CTCs in mPCa Patients
Official title: A Trial to Evaluate the Effect of Applying Leukapheresis to Enrich CTCs in Patients With Metastatic Prostate Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostate Cancer
Circulating Tumor Cell
Leukapheresis
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
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.

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. 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.


Eligibility criteria: 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;

Primary outcomes:
measure: Number of circulating tumor cells
timeFrame: The leukapheresis takes about 2 hours, and CTCs number will be measured in 24 hours after sampling.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University
Study officials:
References: