Prostasomes as Diagnostic Tool for Prostate Cancer Detection
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/9/2018 |
| Start Date: | October 3, 2018 |
| End Date: | October 1, 2023 |
| Contact: | Olivier Loudig, PhD |
| Email: | Olivier.loudig@hackensackmeridian.org |
| Phone: | 5519965302 |
Quantification and Purification of Circulating Prostasomes as Diagnostic Tool for Prostate Cancer Detection
Prostate cancer is the most frequently diagnosed cancer among men over 50 years old in
Western societies, with an incidence that is steadily increasing in most countries. The
current, most commonly used biomarker for prostate cancer is prostate specific antigen (PSA),
which has well known limitations in accuracy and requires additional testing. However,
prostate cancer cells secrete exosomes, also known as prostasomes, which are only detectable
in the blood of prostate cancer patients. The presence of prostasomes in the blood is in
itself a prostate cancer diagnosis. However, the assay that has been designed for the
purification of prostasomes requires additional testing for evaluating its robustness and
usefulness in the clinical setting. Additionally, the evaluation of the cargo of the purified
prostasomes may provide more information on the nature of the prostate cancer, which may help
develop a molecular assay for a prostate cancer liquid biopsy rather than a tissue biopsy.
Therefore, the purpose of this study is two-fold: a validation phase where the purification
of prostasomes will be tested on plasma collected from prostate cancer patients and a
molecular testing phase where the contents of the purified prostasomes will be evaluated on
their ability to determine the grade of the prostate tumors.
Western societies, with an incidence that is steadily increasing in most countries. The
current, most commonly used biomarker for prostate cancer is prostate specific antigen (PSA),
which has well known limitations in accuracy and requires additional testing. However,
prostate cancer cells secrete exosomes, also known as prostasomes, which are only detectable
in the blood of prostate cancer patients. The presence of prostasomes in the blood is in
itself a prostate cancer diagnosis. However, the assay that has been designed for the
purification of prostasomes requires additional testing for evaluating its robustness and
usefulness in the clinical setting. Additionally, the evaluation of the cargo of the purified
prostasomes may provide more information on the nature of the prostate cancer, which may help
develop a molecular assay for a prostate cancer liquid biopsy rather than a tissue biopsy.
Therefore, the purpose of this study is two-fold: a validation phase where the purification
of prostasomes will be tested on plasma collected from prostate cancer patients and a
molecular testing phase where the contents of the purified prostasomes will be evaluated on
their ability to determine the grade of the prostate tumors.
Inclusion Criteria:
- Male
- With elevated PSA
- 18 years and older
- Willingness to participate in the study and compliance with protocol requirements
- Have not received any type of treatment for prostate cancer
Exclusion Criteria:
- Patients with confirmed or suspected prostate cancer that have already received any
type of treatment
- Patients with another primary cancer within the past five years of prostate cancer
diagnosis. However, superficial skin cancers such as basal cell or squamous cell
cancers would not exclude a patient.
We found this trial at
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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