Characterization of Circulating Tumor Cells (CTCs) in High Risk and Early Metastatic Prostate Cancer Patients Using Parsortix® System
Stopped early
Conditions studied: High Risk Prostate Carcinoma, Biochemically Recurrent Prostate Carcinoma, Castration-resistant Prostate Cancer, Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT05437679
- Run by
- Angle plc
- People needed
- 9
- Starts
- 2022-07-05
- Expected to finish
- 2023-08-22
- Last updated by the study team
- 2023-09-05
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
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;
- 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.
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.
Where it is running
- MidLantic Urology — Bala-Cynwyd, Pennsylvania, United States
- MidLantic Urology — Pottstown, Pennsylvania, United States
Full record on ClinicalTrials.gov
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