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NCT03694483Suspended

Prostasomes as Diagnostic Tool for Prostate Cancer Detection

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Suspended
Study type
Observational
Enrollment
600 (estimated)
First submitted
25 Sept 2018
Start date
3 Oct 2018
Primary completion date
1 Oct 2027
Lead sponsor
Hackensack Meridian Health
NCT number
NCT03694483

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with confirmed or suspected prostate cancer that have already received any type of treatment

Other illness

  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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SiteCityCountrySite status
Hackensack University Medical Center
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HackensackUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.