NCT01864135

Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging and Biomarkers

Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Turku University Hospital · Other Government
• Sex: Male
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Prostate cancer has been the most common cancer 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. Due to the low accuracy of TRUS, a systematic biopsy is usually performed instead of targeted TRUS biopsy. As biopsy carries a risk of increase in complications, there is an increasing interest in developing more accurate non-invasive imaging modalities. This study will enroll 150 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. Multiparametric magnetic resonance imaging (mpMRI) at 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

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	3T MRI (Magnetom Verio 3T, Erlangen, Germany)
DEVICE	Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-02-01
• Completion: 2015-11-01
• First posted: 2013-05-29
• Last updated: 2016-01-21

Locations

1 site across 1 country: Finland