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Clinical Trials/NCT03694483
NCT03694483
Suspended
N/A

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

Hackensack Meridian Health1 site in 1 country600 target enrollmentOctober 3, 2018
ConditionsProstate Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Hackensack Meridian Health
Enrollment
600
Locations
1
Primary Endpoint
sensitivity of the prostasome purification methodology
Status
Suspended
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 3, 2018
End Date
October 1, 2026
Last Updated
8 months ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Outcomes

Primary Outcomes

sensitivity of the prostasome purification methodology

Time Frame: 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

Time Frame: 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 Outcomes

  • 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)

Study Sites (1)

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