STHLM3 - Prostate Cancer Diagnostic Trial (STHLM3)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
STHLM3
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Age 50-69
- Residential address in Stockholm County
Exclusion Criteria:
- Previous Prostate Cancer Diagnosis
- Not able to comprehend inform consent material
Sites / Locations
- Karolinska Institutet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
STHLM3
PSA
Arm Description
Outcomes
Primary Outcome Measures
Number of biopsies
Secondary Outcome Measures
Number of Gleason Score ≥ 7
Number of Gleason Score 6
Number of benign
Full Information
NCT ID
NCT03639649
First Posted
August 16, 2018
Last Updated
August 19, 2018
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
1. Study Identification
Unique Protocol Identification Number
NCT03639649
Brief Title
STHLM3 - Prostate Cancer Diagnostic Trial
Acronym
STHLM3
Official Title
STHLM3 - Prostate Cancer Diagnostic Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
STHLM3 is a paired diagnostic trial aiming to assess whether a panel of biomarkers for prostate cancer can substantially reduce the proportion of men referred to biopsy whilst maintaining sensitivity for aggressive prostate cancer
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
58818 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STHLM3
Arm Type
Experimental
Arm Title
PSA
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
STHLM3
Primary Outcome Measure Information:
Title
Number of biopsies
Time Frame
Recorded directly after biopsy
Secondary Outcome Measure Information:
Title
Number of Gleason Score ≥ 7
Time Frame
Recorded directly after biopsy
Title
Number of Gleason Score 6
Time Frame
Recorded directly after biopsy
Title
Number of benign
Time Frame
Recorded directly after biopsy
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 50-69
Residential address in Stockholm County
Exclusion Criteria:
Previous Prostate Cancer Diagnosis
Not able to comprehend inform consent material
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
17177
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
STHLM3 - Prostate Cancer Diagnostic Trial
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