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Predicting Prostate Cancer in Elderly Men

NCT04079699 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2019-09-06

No results posted yet for this study

Summary

We aim to analyze whether the "liquid biopsy" model could increase the specificity of detecting men with an aggressive (defined as Gleason score ≥ 7) prostate cancer and thereby reduce the proportion of men who undergo prostate biopsy, while at the same time maintaining the same sensitivity to detect aggressive prostate cancer as the PSA test alone. Using blood and urine biomarkers together with an algorithm, which incorporates the clinical data, we aim to identify patients who have a high risk of having an aggressive prostate cancer. By performing this non-invasive test we expect that we can reduce need for prostate biopsy and reduce the detection of patients with an indolent prostate cancer (defined by Gleason score ≤ 6). Thereby we aim to reduce the side effects of transrectal ultrasound guided biopsy of the prostate and side-effects of living with an indolent cancer.

Conditions

  • Prostate Cancer (Diagnosis)

Interventions

DIAGNOSTIC_TEST

Liquid Biopsy

Measuring biomarkers in blood and urine samples

DIAGNOSTIC_TEST

Standard biopsy

Histological examination of tissue biopsies

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Lars Lund, MD, DMSci · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2039-10-01
Completion
2039-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04079699 on ClinicalTrials.gov