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Generation of circulating tumor cell derived organoids through enrichment by leukapheresis - A novel drug screening system in metastatic prostate cancer

Recruiting
Conditions
prostate cancer
prostate carcinoma
10038364
Registration Number
NL-OMON46104
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
79
Inclusion Criteria

- metastasized prostate cancer
- age * 18 years
- Written informed consent of the patient
- * 2 adequate peripheral veins as access point for leukapheresis

Exclusion Criteria

- CTC count of < 5 CTCs/7.5 mL of blood
- Patients with a known hypersensitivity to the used LA-anticoagulant
- mHSPC patients with current ADT
- Hemorrhage disease and/or coagulation disorder
- Inadequate liver and/or renal function
- Inadequate hematology and coagulation status
- Chronic viral infections

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary endpoint is the success rate of culturing organoids from CTCs<br /><br>obtained by LA. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary endpoints include the fraction of metastatic PCa patients who have *<br /><br>300 viable CTCs obtained by LA and the exploratory analysis comparing drug<br /><br>sensitivity in organoids to therapy response of the matching patient in the<br /><br>clinic.</p><br>
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