Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05437679
Status:
TERMINATED
Last Update Posted:
2023-09-05
First Post:
2022-06-27
Brief Title:
Characterization of Circulating Tumor Cells CTCs in High Risk and Early Metastatic Prostate Cancer Patients Using Parsortix System
Sponsor:
Angle plc
Organization:
Angle plc
Study Overview
Official Title:
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
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Futility slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHARTER
Brief 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 ie Axumin or PSMA PETCT and men with non-metastatic castration resistant prostate cancer NMCRPC who are about to or have recently undergone NGI ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None