Prostasomes as Diagnostic Tool for Prostate Cancer Detection
- Conditions
- Prostate Cancer
- Interventions
- Diagnostic Test: Genetic analysis for the detection of prostasomes
- Registration Number
- NCT03694483
- Lead Sponsor
- Hackensack Meridian Health
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- Male
- Target Recruitment
- 600
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patient population Genetic analysis for the detection of prostasomes Male individuals with elevated PSA and a positive MRI-driven biopsy AND male individuals with diagnosed prostate cancer (but prior to any treatment) Control Population Genetic analysis for the detection of prostasomes Male individuals with elevated PSA and a negative MRI-driven biopsy
- Primary Outcome Measures
Name Time Method sensitivity of the prostasome purification methodology through study completion - up to 24 months true positive rate of the prostasomes purification methodology using the prostasome detection results for each of the patient specimens (cases and controls)
specificity of the prostasome purification methodology through study completion - up to 24 months true negative rate of the prostasomes purification methodology using the prostasome detection results for each of the patient specimens (cases and controls)
- Secondary Outcome Measures
Name Time Method Time to disease progression(in patient cohort only) Up to 24 months Time to disease relapse (in patient cohort only) Up to 24 months Overall survival (in patient cohort only) Up to 24 months Quantification of the miRNA expression profiles of the purified protostomes both before and after treatment (in patients cohort only) through study completion - up to 24 months identify the top 20 most frequently expressed miRNA markers and their level of expression in each of the case patient specimens
Trial Locations
- Locations (1)
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States