Prostasomes as Diagnostic Tool for Prostate Cancer Detection

Study Overview
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Brief Summary
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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.

Official Title
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Quantification and Purification of Circulating Prostasomes as Diagnostic Tool for Prostate Cancer Detection

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: Genetic analysis for the detection of prostasomes


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient population<br>Male individuals with elevated PSA and a positive MRI-driven biopsy AND male individuals with diagnosed prostate cancer (but prior to any treatment) | Diagnostic Test: Genetic analysis for the detection of prostasomes<br>* Whole blood will be collected and processed within 2 hours. Samples will be brought to Hackensack University Medical Center and will be centrifuged. The plasma samples will be tested for presence of prostasomes using the ExoPLA (Exosome in situ Proximity Ligation Assay) assay and the prostasomes will be purified for further miRNA sequencing.<br>|
| Control Population<br>Male individuals with elevated PSA and a negative MRI-driven biopsy | Diagnostic Test: Genetic analysis for the detection of prostasomes<br>* Whole blood will be collected and processed within 2 hours. Samples will be brought to Hackensack University Medical Center and will be centrifuged. The plasma samples will be tested for presence of prostasomes using the ExoPLA (Exosome in situ Proximity Ligation Assay) assay and the prostasomes will be purified for further miRNA sequencing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity of the prostasome purification methodology | true positive rate of the prostasomes purification methodology using the prostasome detection results for each of the patient specimens (cases and controls) | through study completion - up to 24 months | 
| specificity of the prostasome purification methodology | true negative rate of the prostasomes purification methodology using the prostasome detection results for each of the patient specimens (cases and controls) | through study completion - up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of the miRNA expression profiles of the purified protostomes both before and after treatment (in patients cohort only) | identify the top 20 most frequently expressed miRNA markers and their level of expression in each of the case patient specimens | through study completion - up to 24 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostasomes,, prostate cancer,, biomarkers