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

NCT ID: NCT05437679

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 9 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-05
• Study Completion Date: 2023-08-22

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] (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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Active Surveillance (AS) Controls

Patients with low or very low risk prostate cancer who have been on active surveillance for 5 or more years with a stable PSA or on active surveillance for 2 or more years with negative multiparametric MRI (mpMRI) or mpMRI with a fusion biopsy(ies) confirming low risk disease.

Blood collection

Intervention Type: OTHER

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.

High Risk Localized Prostate Cancer (HRLPC)

Men with high-risk localized prostate cancer, defined as stage pT3a or Gleason score greater than or equal to 8 and/or pre-prostatectomy PSA of greater than or equal to 20 ng/mL.

Blood collection

Intervention Type: OTHER

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.

Biochemically Recurrent Localized Prostate Cancer (BCRLPC)

Systemic and/or hormonal treatment naive men with localized prostate cancer (pathological stages pT2, pT3a or pT4 with TNM N0 or N1 and M0 disease) who have clinical suspicion of biochemical recurrence 2 - 5 months following radical prostatectomy and are scheduled to undergo NGI (i.e., Axumin® or PSMA PETCT) within the next 45 days or have already undergone NGI within the past 45 days.

Blood collection

Intervention Type: OTHER

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.

Non-Metastatic Castration-Resistant Prostate Cancer (NMCRPC)

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) who are scheduled to undergo NGI (i.e., Axumin® or PSMA PETCT) within the next 45 days or have already undergone NGI within the past 45 days and who have not started a new therapy for treatment of their castration-resistant prostate cancer.

Blood collection

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Data collection

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

MidLantic Urology, LLC

UNKNOWN

Sponsor Role: collaborator

Angle plc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose G Moreno, MD

Role: PRINCIPAL_INVESTIGATOR

MidLantic Urology, LLC

Locations

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States

MidLantic Urology

Pottstown, Pennsylvania, United States

Countries

United States

References

Moreno JG, Gomella LG. Evolution of the Liquid Biopsy in Metastatic Prostate Cancer. Urology. 2019 Oct;132:1-9. doi: 10.1016/j.urology.2019.06.006. Epub 2019 Jun 14.

Reference Type: BACKGROUND

PMID: 31207303 (View on PubMed)

Miller MC, Robinson PS, Wagner C, O'Shannessy DJ. The Parsortix Cell Separation System-A versatile liquid biopsy platform. Cytometry A. 2018 Dec;93(12):1234-1239. doi: 10.1002/cyto.a.23571. Epub 2018 Aug 14.

Reference Type: BACKGROUND

PMID: 30107082 (View on PubMed)

Related Links

https://midlanticurology.com/

MidLantic Urology, LLC

https://angleplc.com/

ANGLE plc

Other Identifiers

ANG-015 / MLU-3

Identifier Type: -

Identifier Source: org_study_id