Characterization of Circulating Tumor Cells (CTCs) in High Risk and Early Metastatic Prostate Cancer Patients Using Parsortix® System

Inclusion Criteria

• •Males ≥ 18 years of age;
• •ECOG status of 0 - 2;
• •Signed informed consent;
• •HRLPC cohort (n=25):
• •* Clinical diagnosis of HRLPC, defined as stage pT3a or Gleason score \>8 and/or pre-prostatectomy PSA \>20 ng/mL;
• •* 2-5 months post-radical prostatectomy;
• •* Treatment naïve (i.e. have not received any systemic and/or hormonal therapy since the time of their radical prostatectomy).
• •BCRLPC cohort (n=25):
• •* Patients with localized prostate cancer (pathological stages pT2, pT3a, pT3b or pT4 with TNM N0 or N1 and M0 disease) who have clinical suspicion of biochemical recurrence following a radical prostatectomy;
• •* Have been pre-authorized by insurance to undergo next generation imaging (NGI, such as Axumin® or PSMA PETCT) within the next 45 days or have already undergone NGI within the past 45 days;
• •* Treatment naïve (i.e. have not received any systemic and/or hormonal therapy since the time of their radical prostatectomy).
• •NMCRPC cohort (n=25):
• •* Patients with evidence of non-metastatic castration-resistant prostate cancer (i.e. localized prostate cancer patients with clinical symptoms of disease progression and/or evidence of a rising PSA following hormone therapy);
• •* Have been pre-authorized by insurance to undergo NGI (i.e. Axumin® or PSMA PETCT) within the next 45 days or have already undergone NGI within the past 45 days;
• •* Have not started a new therapy for the treatment of their castration-resistant prostate cancer.
• •Control cohort (n=25):
• •* Patients with low or very low risk prostate cancer who have been on active surveillance (AS) for 5 or more years with a stable PSA or on active surveillance for 2 or more years with negative multiparametric magnetic resonance imaging (mpMRI) or mpMRI with a fusion biopsy confirming low risk disease.