Trials / Completed
CompletedNCT02241122
MRI and Biomarkers in Prostate Cancer
Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging Targeted Biopsies and Biomarkers (Multi-institutional Study)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- Sponsor
- Turku University Hospital · Other Government
- Sex
- Male
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
Prostate cancer has been the most common neoplastic disease in men in Finland over the last ten years. Prostate-specific antigen (PSA) plays an important role in screening of prostate cancer. However, PSA has a limited sensitivity and specificity for prostate cancer detection. Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS) guided biopsy. Because of the low accuracy of TRUS a systematic biopsy is usually performed instead of targeted TRUS biopsy. As biopsy carries a significant risk of complications, there is an increasing interest in developing more accurate non-invasive imaging modalities. This prospective multi-institutional study will enroll 400 men with clinical suspicion of prostate cancer due to higher serum level of PSA than 2.5 ng/ml and/or abnormal digital rectal examination. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 1.5/3 Tesla (T) magnetic field using surface coils will be used to non-invasively predict the presence or absence of prostate cancer. Targeted TRUS guided biopsy based on MRI findings will be performed in addition to routine twelve core TRUS biopsy. Moreover, selected serum and urine biomarkers as well as biomarkers extracted from fresh biopsy sample will be collected and correlated with the presence or absence of prostate cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | prostate biopsy |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2017-11-01
- Completion
- 2018-04-01
- First posted
- 2014-09-16
- Last updated
- 2018-04-18
Locations
5 sites across 1 country: Finland
Source: ClinicalTrials.gov record NCT02241122. Inclusion in this directory is not an endorsement.