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

NCT05437679 | Terminated

• 1 other identifier: ANG-015 / MLU-3
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

surveillance; circulating tumor cells; PETCT; PSMA; Axumin; Parsortix; next generation imaging

Outcome Measures

Primary Outcomes (2)

• CTC number and phenotype

  The population of cells captured from the peripheral blood samples by the Parsortix system will be evaluated using cytological and/or immunofluorescent staining methods to determine the numbers and phenotypes of any rare cells present (e.g., epithelial and/or mesenchymal CTCs, megakaryocytes, etc. alone and/or in clusters). The numbers and phenotypes of any rare cells present will be evaluated for association with the patient disease state (e.g., study group), the presence of metastatic disease as determined by NGI, and disease progression and/or survival (for up to two years following enrollment).

  Baseline

• CTC genotype

  DNA and/or RNA will be isolated from the population of cells captured from the peripheral blood samples by the Parsortix system and will be evaluated using molecular methods (e.g. multiplex gene expression, mutational analysis, sequencing, etc.) to determine the genotype(s) of the harvested cells. The genotype(s) of any rare cells present will be evaluated for association with the patient disease state (e.g., study group), the presence of metastatic disease as determined by NGI, and disease progression and/or survival (for up to two years following enrollment).

  Baseline

Study Arms (4)

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.

Other: Blood collection

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.

Other: Blood collection

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.

Other: Blood collection

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.

Other: Blood collection

Interventions

Blood collection 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.

Also known as: Data collection

Active Surveillance (AS) Controls; Biochemically Recurrent Localized Prostate Cancer (BCRLPC); High Risk Localized Prostate Cancer (HRLPC); Non-Metastatic Castration-Resistant Prostate Cancer (NMCRPC)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients being treated within MidLantic Urology's (MLU's) clinical network (located in southeast Pennsylvania), will be evaluated for eligibility and invited to participate in the study.

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Angle plc: lead
• MidLantic Urology, LLC: collaborator

Study Sites (2)

MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

MidLantic Urology

Pottstown, Pennsylvania, 19464, United States

Location

Related Publications (2)

• 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.

  PMID: 31207303 BACKGROUND

• 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.

  PMID: 30107082 BACKGROUND

Related Links

• MidLantic Urology, LLC
• ANGLE plc

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples will be collected, and the following will be isolated from the whole blood samples: serum, plasma, cells (e.g., CTCs, white blood cells, etc.), circulating cell free DNA, DNA and RNA from isolated cells, etc.

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplastic Cells, Circulating

Interventions

Blood Specimen Collection; Data Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jose G Moreno, MD

  MidLantic Urology, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 29, 2022
• Study Start: July 5, 2022
• Primary Completion: August 22, 2023
• Study Completion: August 22, 2023
• Last Updated: September 5, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)