Prostate Cancer Detection Using the Stockholm3 Test and MR/Fusion Biopsies (STHLM3MR-2)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
MRI/Fusion biopsies
Systematic biopsies
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Permanent postal address in Stockholm
Exclusion Criteria:
• 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
- Capio St Görans Hospital
- GHP Odenplan Urology
- Sophiahemmet Urology
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Traditional
STHLM3+MRI/Fusion
Arm Description
The traditional/control arm consists of PSA testing and if PSA>3ng/ml a systematic biopsy of the prostate is performed.
The experimental arm consists of a Stockholm3 bloodiest and if elevated, an MRI is recommended with targeted biopsies to prostate lesions.
Outcomes
Primary Outcome Measures
Number of detected cancers characterized as Gleason Score ≥7 on evaluation of biopsy specimen
Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm
Secondary Outcome Measures
Number of detected cancer with Gleason Score 6
Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm
Number of performed biopsy procedures in the study arms
Number of performed prostate biopsy procedures counted per study arm
Number of performed MRI in the study arms
Number of performed prostate MRI procedures counted per study arm
Number of infectious complications
As assessed by questionnaire within 2 month after biopsy procedure
Full Information
NCT ID
NCT03377881
First Posted
November 28, 2017
Last Updated
December 10, 2020
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT03377881
Brief Title
Prostate Cancer Detection Using the Stockholm3 Test and MR/Fusion Biopsies
Acronym
STHLM3MR-2
Official Title
STHLM3 MR Phase 2: A New Diagnostic Chain for Prostate Cancer Detection Using the Stockholm3 Test and MR/Fusion Biopsies
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 4, 2018 (Actual)
Primary Completion Date
December 10, 2020 (Actual)
Study Completion Date
December 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
STHLM3-MR Phase 2 is a study comparing traditional prostate cancer detection using PSA and systematic biopsies with the improved pipeline for prostate cancer detection using the STHLM3 test and targeted biopsies in a screening context.
Detailed Description
The overarching strategy of the STHLM3-MR/Fusion projects are to study an improved diagnostic pipeline including an improved blood-based test for identification of men with increased risk of prostate cancer and use of MRI to select men for diagnostic workup with targeted prostate biopsies. The aim is to increase the specificity in early detection of prostate cancer without decreasing the sensitivity of aggressive prostate cancers.
The primary endpoints are the number of performed biopsies, the number of performed MRI and the number of detected high-risk prostate cancers. 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 and development of automated image-analysis.
The STHLM3-MR project is performed in two separate phases, analyzed separately. STHLM3-MR Phase 1 closed inclusion 2017-06-01. All participants underwent target and systematic biopsies together with STHLM3 test analysis. The study is constitutes a current practice cohort and levels of the STHLM3 test were not used for selecting participants.
STHLM3-MR Phase 2 is a study comparing traditional prostate cancer detection using PSA and systematic biopsies with the improved pipeline for prostate cancer detection using the STHLM3 test and targeted biopsies in a screening context.
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
Parallel Assignment
Model Description
Two-step design with a first step using paired design for blood-analysis and a second step using randomisation between prostate biopsy strategy.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12750 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional
Arm Type
Other
Arm Description
The traditional/control arm consists of PSA testing and if PSA>3ng/ml a systematic biopsy of the prostate is performed.
Arm Title
STHLM3+MRI/Fusion
Arm Type
Experimental
Arm Description
The experimental arm consists of a Stockholm3 bloodiest and if elevated, an MRI is recommended with targeted biopsies to prostate lesions.
Intervention Type
Procedure
Intervention Name(s)
MRI/Fusion biopsies
Intervention Description
The intervention in the experimental arm is an MRI with targeted biopsies using fusion technique to prostate lesions.
Intervention Type
Procedure
Intervention Name(s)
Systematic biopsies
Intervention Description
The intervention in the control arm is traditional systematic biopsies of the prostate.
Primary Outcome Measure Information:
Title
Number of detected cancers characterized as Gleason Score ≥7 on evaluation of biopsy specimen
Description
Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm
Time Frame
At 2 months after study closure (last included biopsy procedure)
Secondary Outcome Measure Information:
Title
Number of detected cancer with Gleason Score 6
Description
Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm
Time Frame
At 2 months after study closure (last included biopsy procedure)
Title
Number of performed biopsy procedures in the study arms
Description
Number of performed prostate biopsy procedures counted per study arm
Time Frame
At 2 months after study closure (last included biopsy procedure)
Title
Number of performed MRI in the study arms
Description
Number of performed prostate MRI procedures counted per study arm
Time Frame
At 2 months after study closure (last included biopsy procedure)
Title
Number of infectious complications
Description
As assessed by questionnaire within 2 month after biopsy procedure
Time Frame
Questionnaire collection finalised within 2months after last biopsy procedure in study
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Permanent postal address in Stockholm
Exclusion Criteria:
• 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
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Capio St Görans Hospital
City
Stockholm
Country
Sweden
Facility Name
GHP Odenplan Urology
City
Stockholm
Country
Sweden
Facility Name
Sophiahemmet Urology
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28753850
Citation
Nordstrom T, Picker W, Aly M, Jaderling F, Adolfsson J, Strom P, Haug ES, Eklund M, Carlsson S, Gronberg H. Detection of Prostate Cancer Using a Multistep Approach with Prostate-specific Antigen, the Stockholm 3 Test, and Targeted Biopsies: The STHLM3 MRI Project. Eur Urol Focus. 2017 Dec;3(6):526-528. doi: 10.1016/j.euf.2017.01.014. Epub 2017 Mar 28.
Results Reference
background
PubMed Identifier
34391509
Citation
Nordstrom T, Discacciati A, Bergman M, Clements M, Aly M, Annerstedt M, Glaessgen A, Carlsson S, Jaderling F, Eklund M, Gronberg H; STHLM3 study group. Prostate cancer screening using a combination of risk-prediction, MRI, and targeted prostate biopsies (STHLM3-MRI): a prospective, population-based, randomised, open-label, non-inferiority trial. Lancet Oncol. 2021 Sep;22(9):1240-1249. doi: 10.1016/S1470-2045(21)00348-X. Epub 2021 Aug 13.
Results Reference
derived
PubMed Identifier
34237810
Citation
Eklund M, Jaderling F, Discacciati A, Bergman M, Annerstedt M, Aly M, Glaessgen A, Carlsson S, Gronberg H, Nordstrom T; STHLM3 consortium. MRI-Targeted or Standard Biopsy in Prostate Cancer Screening. N Engl J Med. 2021 Sep 2;385(10):908-920. doi: 10.1056/NEJMoa2100852. Epub 2021 Jul 9.
Results Reference
derived
PubMed Identifier
31201191
Citation
Nordstrom T, Jaderling F, Carlsson S, Aly M, Gronberg H, Eklund M. Does a novel diagnostic pathway including blood-based risk prediction and MRI-targeted biopsies outperform prostate cancer screening using prostate-specific antigen and systematic prostate biopsies? - protocol of the randomised study STHLM3MRI. BMJ Open. 2019 Jun 14;9(6):e027816. doi: 10.1136/bmjopen-2018-027816.
Results Reference
derived
Links:
URL
http://sthlm3.se
Description
Study homepage
Learn more about this trial
Prostate Cancer Detection Using the Stockholm3 Test and MR/Fusion Biopsies
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