NCT03956108

Brief Summary

The STHLM3-AS study will evaluate the specificity of a new proposed protocol for active surveillance using the Stockholm3 test in combination with MRI targeted biopsies for prostate cancer detection in men with diagnosed low-risk prostate cancer undergoing active surveillance in comparison to conventional follow up using PSA and systematic biopsies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Aug 2018

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, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

1.4 years

First QC Date

May 15, 2019

Last Update Submit

September 9, 2020

Conditions

Prostate Cancer

Keywords

Active Surveillance

Outcome Measures

Primary Outcomes (1)

  • Specificity of minimally invasive active surveillance

    Number of biopsies using the Stockholm3 test in combination with MRI/targeted biopsies vs. number of systematic biopsies at equal sensitivity for detecting Gleason Score ≥ 7 disease

    Up to five years

Secondary Outcomes (2)

  • Predictive value of Stockholm3 test velocity

    Up to five years

  • Clinically significant cut off for Stockholm3 test as a monitoring test

    Up to five years

Study Arms (2)

MRI/Fusion biopsies

EXPERIMENTAL

Stockholm3+MRI+targeted biopsies

Diagnostic Test: MRI+targeted biopsies+Stockholm3-test

Systematic biopsies

ACTIVE COMPARATOR

PSA+systematic biopsies

Diagnostic Test: PSA + systematic biopsies

Interventions

MRI+targeted biopsies+Stockholm3-testDIAGNOSTIC_TEST

MRI, evaluation in accordance with PI-RADS v2, and targeted biopsies. Stockholm3-test.

MRI/Fusion biopsies
PSA + systematic biopsiesDIAGNOSTIC_TEST

Systematic biopsies and PSA test

Systematic biopsies

Eligibility Criteria

Age45 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly men present with prostate cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men in the STHLM3 study, diagnosed with a low risk prostate cancer and on AS

You may not qualify if:

  • History of treatment for prostate cancer; surgery, radiation, chemotherapy or hormonal treatment.
  • Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia
  • Contraindications for magnetic resonance imaging (MRI) e.g. pacemaker, magnetic cerebral clips, cochlear implants or severe claustrophobia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, Solna, 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 Officials

  • Anna Lantz, MD PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 15, 2019

First Posted

May 20, 2019

Study Start

August 1, 2018

Primary Completion

December 12, 2019

Study Completion

March 1, 2020

Last Updated

September 10, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Information obtained in the study will be collected in one database. The purpose of the database is to collect study data in a proper and safe way for a long time. All information about the participants will be treated with utmost confidentiality and with strong safeguards to preserve their anonymity. Information that can be used to identify the participant (such as name, address and social security numbers) is always kept separate from other data (such as survey responses and blood tests). All questionnaire data and test results will be treated to prevent unauthorized access to them. The samples will get a unique code so that outsiders cannot identify them. The participants' samples are treated in accordance with the Swedish Biobank Act. Everyone who works with STHLM3 are under confidentiality agreements. Results from the study are presented only as statistics in which individual answers cannot be traced.

Locations

SE(1)