Clinical trial NCT03694483: Prostasomes as Diagnostic Tool for Prostate Cancer Detection
Official title: Quantification and Purification of Circulating Prostasomes as Diagnostic Tool for Prostate Cancer Detection
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Prostate Cancer
Keywords: prostasomes,
prostate cancer,
biomarkers
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
Collaborators: name: Uppsala University, Sweden (Department of Immunology, Genetics and Pathology)
First posted: 2018-10-03
Enrollment: 600
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All male patients with elevated PSA and suspected for prostate cancer or patients with diagnosed prostate cancer but prior to treatment will be invited to participate. Depending on the results from the diagnostic MRI-guided biopsy, participants will be assigned to either the control cohort (if biopsy is negative) or the patient cohort (if biopsy is positive).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: sensitivity of the prostasome purification methodology
timeFrame: through study completion - up to 24 months
measure: specificity of the prostasome purification methodology
timeFrame: through study completion - up to 24 months
Secondary outcomes:
measure: Quantification of the miRNA expression profiles of the purified protostomes both before and after treatment (in patients cohort only)
timeFrame: through study completion - up to 24 months
measure: Time to disease progression(in patient cohort only)
timeFrame: Up to 24 months
measure: Time to disease relapse (in patient cohort only)
timeFrame: Up to 24 months
measure: Overall survival (in patient cohort only)
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
Study officials:
References:
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