Probing intercellular heterogeneity in circulating tumor cells of de novo metastatic hormone sensitive prostate cancer patients
- Conditions
- Prostate cancer, Metastatic hormone sensitive prostate cancer, mHSPC
- Registration Number
- NL-OMON25327
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 134
•De novo mHSPC patient, no prior treatment for prostate cancer, including local treatments and ADT
•Intention to start treatment with ADT + docetaxel or ADT + Second Generation Androgen Receptor Targeted therapy
•Age =18 years
•WHO performance status =2.
•= 2 adequate peripheral veins as access point for leukapheresis.
•Known hypersensitivity to the anticoagulant used for apheresis
•Inadequate cardiac function or severe cardiovascular comorbidity
-Heart failure NYHA class III/IV
•Hemoglobin level < 6.0 mmol/L
•Coagulation disorders as defined by one of the following:
-Coagulation disorder in medical history
-Platelet count < 40 x 109/L;
Patients without anticoagulant therapy which affects PT or APTT, when:
-PT > 1.5 x ULN or PT-INR > 1.5 x ULN
-APTT > 1.5 x ULN
Patients with anticoagulant therapy which affects PT or APTT, when:
-PT or APTT > 1.5 x the upper limit of the desired therapeutic window
-Total bilirubin > 2.5 x ULN
•Known chronic viral infections
•Second active malignancy
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of patients from who 30 single viable CTCs can be isolated from the DLA product.
- Secondary Outcome Measures
Name Time Method