Prostate Magnetic Resonance Imaging in Patient With Previous Negative Biopsies (PROMANEG)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
3T multiparametric MRI
Transrectal ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Turku University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRI
Arm Description
Comparison of targeted transrectal ultrasound guided prostate biopsies based on 3T multiparametric MRI findings to systematic non-targeted transrectal ultrasound guided prostate biopsies
Outcomes
Primary Outcome Measures
Diagnostic accuracy of multiparametric MRI in prostate cancer diagnosis
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 Outcome Measures
Full Information
NCT ID
NCT02388126
First Posted
March 8, 2015
Last Updated
April 16, 2018
Sponsor
Turku University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02388126
Brief Title
Prostate Magnetic Resonance Imaging in Patient With Previous Negative Biopsies
Acronym
PROMANEG
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRI
Arm Type
Experimental
Arm Description
Comparison of targeted transrectal ultrasound guided prostate biopsies based on 3T multiparametric MRI findings to systematic non-targeted transrectal ultrasound guided prostate biopsies
Intervention Type
Device
Intervention Name(s)
3T multiparametric MRI
Intervention Description
Magnetom Verio 3T, Erlangen, Germany
Intervention Type
Device
Intervention Name(s)
Transrectal ultrasound
Intervention Description
Bk Medical Pro Focus Ultraview 2202 system
Primary Outcome Measure Information:
Title
Diagnostic accuracy of multiparametric MRI in prostate cancer diagnosis
Description
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.
Time Frame
3 mounths
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J Boström, Adj. Prof.
Organizational Affiliation
Turku University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20100
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Prostate Magnetic Resonance Imaging in Patient With Previous Negative Biopsies
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