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NCT Number: NCT03694483

Prostasomes as Diagnostic Tool for Prostate Cancer Detection

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.

Why the study stopped: Staffing changes, pending funding renewal
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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Genetic analysis for the detection of prostasomes

Diagnostic Test

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.

Primary outcomes

  1. 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)

  2. 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

  1. 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

  2. Time to disease progression(in patient cohort only)

    Time frame: Up to 24 months

  3. Time to disease relapse (in patient cohort only)

    Time frame: Up to 24 months

  4. Overall survival (in patient cohort only)

    Time frame: Up to 24 months

Sponsors and collaborators

Lead sponsor

Hackensack Meridian Health

Other

Collaborators

  • Uppsala University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Oct 3, 2018
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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