NCT03639649

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58,818

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

August 16, 2018

Last Update Submit

August 19, 2018

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of biopsies

    Recorded directly after biopsy

Secondary Outcomes (3)

  • Number of Gleason Score ≥ 7

    Recorded directly after biopsy

  • Number of Gleason Score 6

    Recorded directly after biopsy

  • Number of benign

    Recorded directly after biopsy

Study Arms (2)

STHLM3

EXPERIMENTAL
Diagnostic Test: STHLM3

PSA

ACTIVE COMPARATOR
Diagnostic Test: STHLM3

Interventions

STHLM3DIAGNOSTIC_TEST
PSASTHLM3

Eligibility Criteria

Age50 Years - 69 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50-69
  • Residential address in Stockholm County

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 17177, Sweden

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 16, 2018

First Posted

August 21, 2018

Study Start

August 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

August 21, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)