search
Back to results

STHLM3 - Prostate Cancer Diagnostic Trial (STHLM3)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
STHLM3
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

50 Years - 69 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

First Posted
August 16, 2018
Last Updated
August 19, 2018
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
search

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

We'll reach out to this number within 24 hrs