Prostasomes as Diagnostic Tool for Prostate Cancer Detection

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 25, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 15, 2018

Estimated Primary Completion Date

October 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Quantification of the miRNA expression profiles of the purified protostomes both before and after treatment (in patients cohort only)[ Time Frame: 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
Time to disease progression(in patient cohort only)[ Time Frame: Up to 24 months ]
Time to disease relapse (in patient cohort only)[ Time Frame: Up to 24 months ]
Overall survival (in patient cohort only)[ Time Frame: Up to 24 months ]

Descriptive Information

Brief Title ^ICMJE

Prostasomes as Diagnostic Tool for Prostate Cancer Detection

Official Title ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Diagnostic Test: Genetic analysis for the detection of prostasomes
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.

Study Arms

: Patient population
Male individuals with elevated PSA and a positive MRI-driven biopsy
: Control Population
Male individuals with elevated PSA and a negative MRI-driven biopsy

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

600

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 1, 2023

Estimated Primary Completion Date

October 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Male - With elevated PSA - 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.

Sex/Gender

Sexes Eligible for Study:

Male

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Hackensack Meridian Health

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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