NCT05437679

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 9 (actual)
• Sponsor: Angle plc · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• High Risk Prostate Carcinoma
• Biochemically Recurrent Prostate Carcinoma
• Castration-resistant Prostate Cancer
• Prostate Cancer

Interventions

Type	Name	Description
OTHER	Blood collection	Peripheral blood will be collected from each subject at a single time point and data will be collected from a review of each subject's medical records.

Timeline

• Start date: 2022-07-05
• Primary completion: 2023-08-22
• Completion: 2023-08-22
• First posted: 2022-06-29
• Last updated: 2023-09-05

Locations

2 sites across 1 country: United States