NCT02788825

Brief Summary

Prostate cancer is a leading cause of cancer death among men in the Western world. Early detection of prostate cancer has been shown to decrease mortality, but has limitations with low specificity leading to unnecessary biopsies and over-diagnosis of low-risk cancers. The STHLM3 trial has paved the way for improved specificity in early detection of prostate cancer using the blood-based STHLM3 test for identifying men at increased risk of harbouring significant prostate cancer. Targeted prostate biopsies based on MRI images have been shown to increase sensitivity of high-grade cancers compared to the currently used systematic biopsies, but existing evidence are contradictory and not free from methodological flaws. The primary aim of STHLM3-MR/Fusion is to increase the specificity in early detection of prostate cancer without decreasing the sensitivity of aggressive prostate cancers by introducing targeted prostate biopsies and comparing to traditional prostate biopsies. The primary endpoints are the number of performed biopsies and the number of detected high-grade prostate cancers defined as Gleason 7 or higher. Secondary endpoints include the number of low risk prostate cancers diagnosed and the proportion of patients with up-or downgraded disease after assessment of prostatectomy specimen. Additional aims include to assess the health economic consequences of implementing MRI based prostate cancer diagnostics and to improve the quality and effectiveness of prostate cancer diagnosis in the routine health care in Stockholm. The STHLM3-MR/Fusion project will be performed in two separate phases, analyzed separately. Based on power calculations, approximately 500 planned for prostate biopsies will be included in the first phase. Men who have previously been diagnosed with prostate cancer may not take part in the study. The study period of Phase 1 is March 2016 to January 2017. The second phase will start in autumn 2016 and end by December 2017.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
687

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
2 countries

2 active sites

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

April 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

1.3 years

First QC Date

May 11, 2016

Last Update Submit

August 17, 2017

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • Estimated number of targeted biopsies needed to maintain Gleason sum 7 sensitivity as compared with systematic biopsies.

    Assessed after 500 (paired) biopsies are performed in Stockholm. Timeframe: from April 2016 to April 2017, up to 1 year

  • Total number Gleason sum ≥7 tumours detected by targeted and systematic biopsies, respectively

    Assessed after 500 (paired) biopsies are performed in Stockholm. Timeframe: from April 2016 to April 2017, up to 1 year

Interventions

Targeted biopsies using Magnetic Resonance Imaging guidingPROCEDURE

Prostate biopsies targeted by findings on MRI where findings are classified according to PI-RADS v2.

Eligibility Criteria

Age45 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men age 45-75 years referred to any of the participating urological centers for prostate biopsies

You may not qualify if:

  • A prior diagnosis of prostate cancer (ICD-9 C61)
  • Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia
  • Contraindications for magnetic resonance imaging (MRI) eg pacemaker, magnetic cerebral clips, cochlear implants or severe claustrophobia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aleris Oslo

Oslo, Norway

Location

Karolinska Universitetssjukhuset, Solna

Stockholm, 17177, Sweden

Location

Related Publications (1)

  • Lantz A, Haug ES, Picker W, Crippa A, Jaderling F, Mortezavi A, Nordstrom T. Effect of information on prostate biopsy history on biopsy outcomes in the era of MRI-targeted biopsies. World J Urol. 2021 Apr;39(4):1153-1159. doi: 10.1007/s00345-020-03277-x. Epub 2020 May 29.

    PMID: 32472278DERIVED

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Tobias Nordström, MD PhD

    Dpt Medical Epidemiology and Biostatistics, Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

May 11, 2016

First Posted

June 2, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

NO(1)SE(1)