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

ANG-015 / MLU-3 (CHARTER Study): Characterization of Circulating Tumor Cells Isolated Using the Parsortix® System in High Risk and Early Metastatic Prostate Cancer Patients

This study is designed to evaluate the presence and numbers of circulating tumor cells (CTCs) and cancer related gene expression levels in subjects with localized high-risk prostate cancer (HRLPC) and from subjects with non-metastatic disease experiencing biochemical recurrence and castration-resistance (BCRLPC and NMCRPC groups, respectively) who are about to undergo next generation imaging (NGI, such as Axumin® or PSMA PETCT). The investigators will also evaluate subjects with localized indolent prostate cancer who are on active surveillance (AS) as a control population. The CTC and gene expression results will be evaluated for association with disease state and progression and survival.

Patients who meet the eligibility criteria and provide written informed consent will be enrolled into the study. The four (4) groups of patients to be enrolled into the study will consist of: 1) men with low risk localized prostate cancer (LPC) on active surveillance (AS control group), 2) treatment naïve men with high risk LPC (HRLPC) who are 2 - 5 months out after having a radical prostatectomy, 3) treatment naïve men with biochemically recurrent LPC (BCRLPC) who are about to or have recently undergone next generation imaging [NGI] (i.e. Axumin® or PSMA PETCT), and men with non-metastatic castration resistant prostate cancer (NMCRPC) who are about to or have recently undergone NGI (i.e. Axumin® or PSMA PETCT). The goal is to enroll a total of 25 evaluable patients into each study group (HRLPC, BCRLPC, NMCRPC and AS) and collect up to ~29mL of blood from each patient as a single timepoint for evaluation. HRLPC patients will have blood draw 2 - 5 months following their radical prostatectomy procedure, BCRLPC and NMCRPC patients will have their blood drawn within 45 days prior to or after their scheduled NGI study and prior to initiation of a new treatment for their disease, and AS patients will have their blood drawn either after having a stable PSA for greater than 5 years or greater than 2 years after having a biopsy confirming low risk disease. All patients will be followed for up to 2 years after enrollment for disease progression and survival status.

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.

Exclusion Criteria:

• Documented evidence of brain metastases;
• ECOG status of 3 or greater;
• Unable to provide informed consent or a high risk that the patient may not comply with the protocol requirements.