NCT02388126

Prostate Magnetic Resonance Imaging in Patient With Previous Negative Biopsies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Turku University Hospital · Other Government
• Sex: Male
• Age: 40 Years – 80 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. While, as many as 47% of the ultra-sound guided biopsies may be false negative and biopsies carry 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 previous negative biopsies and clinical suspicion of prostate cancer due to serum level of PSA higher than 2.5 ng/ml or abnormal digital rectal examination (DRE) or patients in active surveillance due to low risk prostate carcinoma. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 3 Tesla (T) magnetic field using surface coils will be used to non-invasively predict the presence or absence of prostate cancer. In addition to routine 12-core TRUS biopsies, targeted TRUS guided biopsy based on MRI findings will be performed.

Conditions

• Prostate Cancer

Interventions

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

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-02-01
• Completion: 2016-09-01
• First posted: 2015-03-13
• Last updated: 2018-04-18

Locations

1 site across 1 country: Finland