STHLM3-MR: Comparing Standard With Targeted Prostate Biopsies
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Targeted biopsies using Magnetic Resonance Imaging guiding
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Men age 45-75 years referred to any of the participating urological centers for prostate biopsies
Exclusion Criteria:
- A prior diagnosis of prostate cancer (ICD-9 C61)
- Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia
- Contraindications for magnetic resonance imaging (MRI) eg pacemaker, magnetic cerebral clips, cochlear implants or severe claustrophobia.
Sites / Locations
- Aleris Oslo
- Karolinska Universitetssjukhuset, Solna
Outcomes
Primary Outcome Measures
Estimated number of targeted biopsies needed to maintain Gleason sum 7 sensitivity as compared with systematic biopsies.
Total number Gleason sum ≥7 tumours detected by targeted and systematic biopsies, respectively
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02788825
Brief Title
STHLM3-MR: Comparing Standard With Targeted Prostate Biopsies
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prostate cancer is a leading cause of cancer death among men in the Western world. Early detection of prostate cancer has been shown to decrease mortality, but has limitations with low specificity leading to unnecessary biopsies and over-diagnosis of low-risk cancers. The STHLM3 trial has paved the way for improved specificity in early detection of prostate cancer using the blood-based STHLM3 test for identifying men at increased risk of harbouring significant prostate cancer.
Targeted prostate biopsies based on MRI images have been shown to increase sensitivity of high-grade cancers compared to the currently used systematic biopsies, but existing evidence are contradictory and not free from methodological flaws.
The primary aim of STHLM3-MR/Fusion is to increase the specificity in early detection of prostate cancer without decreasing the sensitivity of aggressive prostate cancers by introducing targeted prostate biopsies and comparing to traditional prostate biopsies. The primary endpoints are the number of performed biopsies and the number of detected high-grade prostate cancers defined as Gleason 7 or higher. Secondary endpoints include the number of low risk prostate cancers diagnosed and the proportion of patients with up-or downgraded disease after assessment of prostatectomy specimen. Additional aims include to assess the health economic consequences of implementing MRI based prostate cancer diagnostics and to improve the quality and effectiveness of prostate cancer diagnosis in the routine health care in Stockholm.
The STHLM3-MR/Fusion project will be performed in two separate phases, analyzed separately. Based on power calculations, approximately 500 planned for prostate biopsies will be included in the first phase. Men who have previously been diagnosed with prostate cancer may not take part in the study. The study period of Phase 1 is March 2016 to January 2017. The second phase will start in autumn 2016 and end by December 2017.
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
687 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Targeted biopsies using Magnetic Resonance Imaging guiding
Intervention Description
Prostate biopsies targeted by findings on MRI where findings are classified according to PI-RADS v2.
Primary Outcome Measure Information:
Title
Estimated number of targeted biopsies needed to maintain Gleason sum 7 sensitivity as compared with systematic biopsies.
Time Frame
Assessed after 500 (paired) biopsies are performed in Stockholm. Timeframe: from April 2016 to April 2017, up to 1 year
Title
Total number Gleason sum ≥7 tumours detected by targeted and systematic biopsies, respectively
Time Frame
Assessed after 500 (paired) biopsies are performed in Stockholm. Timeframe: from April 2016 to April 2017, up to 1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men age 45-75 years referred to any of the participating urological centers for prostate biopsies
Exclusion Criteria:
A prior diagnosis of prostate cancer (ICD-9 C61)
Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia
Contraindications for magnetic resonance imaging (MRI) eg pacemaker, magnetic cerebral clips, cochlear implants or severe claustrophobia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Nordström, MD PhD
Organizational Affiliation
Dpt Medical Epidemiology and Biostatistics, Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aleris Oslo
City
Oslo
Country
Norway
Facility Name
Karolinska Universitetssjukhuset, Solna
City
Stockholm
ZIP/Postal Code
17177
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32472278
Citation
Lantz A, Haug ES, Picker W, Crippa A, Jaderling F, Mortezavi A, Nordstrom T. Effect of information on prostate biopsy history on biopsy outcomes in the era of MRI-targeted biopsies. World J Urol. 2021 Apr;39(4):1153-1159. doi: 10.1007/s00345-020-03277-x. Epub 2020 May 29.
Results Reference
derived
Links:
URL
http://sthlm3.se
Description
Website STHLM3 projects
Learn more about this trial
STHLM3-MR: Comparing Standard With Targeted Prostate Biopsies
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