Prostate Magnetic Resonance Imaging in Patient With Previous Negative Biopsies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Turku University Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy of multiparametric MRI in prostate cancer diagnosis
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Language spoken: Finnish or Swedish
- •Clinical suspicion of prostate cancer and/or previous negative prostate biopsies and MRI target
- •Previous diagnosis of prostate carcinoma and patient on active surveillance
- •Mental status: Patients must be able to understand the meaning of the study
- •Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff
Exclusion Criteria
- •Language spoken: Finnish or Swedish
- •Clinical suspicion of prostate cancer and/or previous negative prostate biopsies and MRI target
- •Previous diagnosis of prostate carcinoma and patient on active surveillance
- •Mental status: Patients must be able to understand the meaning of the study
- •Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff
Arms & Interventions
MRI
Comparison of targeted transrectal ultrasound guided prostate biopsies based on 3T multiparametric MRI findings to systematic non-targeted transrectal ultrasound guided prostate biopsies
Intervention: 3T multiparametric MRI (Device)
MRI
Comparison of targeted transrectal ultrasound guided prostate biopsies based on 3T multiparametric MRI findings to systematic non-targeted transrectal ultrasound guided prostate biopsies
Intervention: Transrectal ultrasound (Device)
Outcomes
Primary Outcomes
Diagnostic accuracy of multiparametric MRI in prostate cancer diagnosis
Time Frame: 3 mounths
Multiparametric MRI is performed in patients with previous negative biopsies with clinical suspicion of prostate cancer (elevated PSA and/or abnormal DRE) or in patients in active surveillance due to low risk prostate carcinoma. The accuracy will be determined using the results from transrectal ultrasound guided biopsies.
Secondary Outcomes
No secondary outcomes reported
Investigators
Peter Boström
Adj. prof.
Turku University Hospital