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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05437679
Recruitment Status : Recruiting
First Posted : June 29, 2022
Last Update Posted : July 1, 2022
Sponsor:
Collaborator:
MidLantic Urology, LLC
Information provided by (Responsible Party):
Angle plc

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.

Condition or disease Intervention/treatment
High Risk Prostate Carcinoma Biochemically Recurrent Prostate Carcinoma Castration-resistant Prostate Cancer Prostate Cancer Other: Blood collection

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : June 29, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : July 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
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
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.
Other Name: Data 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
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.
Other Name: Data 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
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.
Other Name: Data 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
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.
Other Name: Data collection




Primary Outcome Measures :
  1. CTC number and phenotype [ Time Frame: Baseline ]
    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).

  2. CTC genotype [ Time Frame: Baseline ]
    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).


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05437679


Contacts
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Contact: Michael C Miller, BS 215-872-2982 c.miller@angleplc.com
Contact: Cheryl Zinar, RN, BSN 610-632-4137 czinar@midlanticurology.com

Locations
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United States, Pennsylvania
MidLantic Urology Recruiting
Bala-Cynwyd, Pennsylvania, United States, 19004
Contact: Cheryl Zinar, RN, BSN    610-632-4137    czinar@midlanticurology.com   
Principal Investigator: Jose G Moreno, MD         
MidLantic Urology Recruiting
Pottstown, Pennsylvania, United States, 19464
Contact: Cheryl Zinar, RN, BSN    610-632-4137    czinar@midlanticurology.com   
Principal Investigator: Jose G Moreno, MD         
Sponsors and Collaborators
Angle plc
MidLantic Urology, LLC
Investigators
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Principal Investigator: Jose G Moreno, MD MidLantic Urology, LLC
Additional Information:
Publications:
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Responsible Party: Angle plc
ClinicalTrials.gov Identifier: NCT05437679    
Other Study ID Numbers: ANG-015 / MLU-3
First Posted: June 29, 2022    Key Record Dates
Last Update Posted: July 1, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data from this study will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Angle plc:
surveillance
circulating tumor cells
PETCT
PSMA
Axumin
Parsortix
next generation imaging
Additional relevant MeSH terms:
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Carcinoma
Prostatic Neoplasms
Neoplastic Cells, Circulating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes