Probing Intercellular heterogeneity in Circulating TUmor cells of de novo metastatic Hormone Sensitive Prostate CanceR patiEntS
- Conditions
- Metastatic hormone sensitive prostate cancermetastatic prostate cancer10038588
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 invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method