NCT04079699Completed
Predicting Prostate Cancer in Elderly Men
Predicting Prostate Cancer Using a Panel of Plasma and Urine Biomarkers Combined in an Algorithm in Elderly Men Above 70 Years
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 205 (actual)
- First submitted
- 3 Sept 2019
- Start date
- 1 Jan 2020
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- Odense University Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT04079699
What you commit to
- Study type: Interventional
- Participants enrolled: 205
- From 1 Jan 2020 to the primary completion date, 1 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously diagnosed with prostate cancer
- Receiving treatment influencing PSA levels
- Medical conditions that may interfere with the study such as previously cancer-related therapy
Other
- Life expectancy of less than 10 years
- MRI of the prostate within the last 2 years
- Digital rectal examination of the prostate within 24 hours or ejaculation within 24 hours
Who the study is looking for
- Suspicion of prostate cancer due to elevated PSA, and/or palpable tumor in the prostate
- Indication for digital rectal examination and trans-rectal ultrasound with biopsy
- Age: 70 years or above
- PSA: 20 or above
- Able to provide informed written consent (competent adults only)
Age in the registry: 70 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Urology, Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.