STHLM3 - Prostate Cancer Diagnostic Trial

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: STHLM3

• Registration Number: NCT03639649
• Lead Sponsor: Karolinska Institutet

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2018-08
• Study First Submitted: 2018-08-16
• Study First Submitted QC: 2018-08-19
• Last Update Submitted: 2018-08-19
• Study First Posted: 2018-08-21
• Last Update Posted: 2018-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 58818

Inclusion Criteria

• Age 50-69
• Residential address in Stockholm County

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Exclusion Criteria

• Previous Prostate Cancer Diagnosis
• Not able to comprehend inform consent material

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PSA	STHLM3	-
STHLM3	STHLM3	-

Primary Outcome Measures

Name	Time	Method
Number of biopsies	Recorded directly after biopsy

Secondary Outcome Measures

Name	Time	Method
Number of benign	Recorded directly after biopsy
Number of Gleason Score ≥ 7	Recorded directly after biopsy
Number of Gleason Score 6	Recorded directly after biopsy

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden