Status:
TERMINATED
Characterization of Circulating Tumor Cells (CTCs) in High Risk and Early Metastatic Prostate Cancer Patients Using Parsortix® System
Lead Sponsor:
Angle plc
Collaborating Sponsors:
MidLantic Urology, LLC
Conditions:
High Risk Prostate Carcinoma
Biochemically Recurrent Prostate Carcinoma
Eligibility:
MALE
18+ years
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...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 5 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 22 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05437679
Start Date
July 5 2022
End Date
August 22 2023
Last Update
September 5 2023
Active Locations (2)
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1
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States, 19004
2
MidLantic Urology
Pottstown, Pennsylvania, United States, 19464