Prostate Magnetic Resonance Imaging in Patient With Previous Negative Biopsies

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Device: 3T multiparametric MRI; Device: Transrectal ultrasound

• Registration Number: NCT02388126
• Lead Sponsor: Turku University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-08
• Study First Submitted QC: 2015-03-08
• Study First Posted: 2015-03-13
• Primary Completion: 2016-02
• Study Completion: 2016-09
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI	Transrectal ultrasound	Comparison of targeted transrectal ultrasound guided prostate biopsies based on 3T multiparametric MRI findings to systematic non-targeted transrectal ultrasound guided prostate biopsies
MRI	3T multiparametric MRI	Comparison of targeted transrectal ultrasound guided prostate biopsies based on 3T multiparametric MRI findings to systematic non-targeted transrectal ultrasound guided prostate biopsies

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of multiparametric MRI in prostate cancer diagnosis	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.

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland