Prostasomes as Diagnostic Tool for Prostate Cancer Detection

Hackensack Meridian Health

Status

Suspended

Conditions

Prostate Cancer

Treatments

Diagnostic Test: Genetic analysis for the detection of prostasomes

Study type

Observational

Funder types

Other

Identifiers

NCT03694483

Pro2018-0517

Details and patient eligibility

About

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.

We will collaborate with Dr. Masood Kamali-Moghaddam at the Uppsala University (Department of Immunology, Genetics and Pathology) for molecular assay processing.

Enrollment

600 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male
With elevated PSA or patients with diagnosed prostate cancer
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.