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STHLM3-MR: Comparing Standard With Targeted Prostate Biopsies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02788825
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : August 22, 2017
Information provided by (Responsible Party):
Tobias Nordström, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: Targeted biopsies using Magnetic Resonance Imaging guiding Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 687 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : April 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Intervention Details:
  • Procedure: Targeted biopsies using Magnetic Resonance Imaging guiding
    Prostate biopsies targeted by findings on MRI where findings are classified according to PI-RADS v2.

Primary Outcome Measures :
  1. Estimated number of targeted biopsies needed to maintain Gleason sum 7 sensitivity as compared with systematic biopsies. [ Time Frame: Assessed after 500 (paired) biopsies are performed in Stockholm. Timeframe: from April 2016 to April 2017, up to 1 year ]
  2. Total number Gleason sum ≥7 tumours detected by targeted and systematic biopsies, respectively [ Time Frame: Assessed after 500 (paired) biopsies are performed in Stockholm. Timeframe: from April 2016 to April 2017, up to 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02788825

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Aleris Oslo
Oslo, Norway
Karolinska Universitetssjukhuset, Solna
Stockholm, Sweden, 17177
Sponsors and Collaborators
Karolinska Institutet
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Principal Investigator: Tobias Nordström, MD PhD Dpt Medical Epidemiology and Biostatistics, Karolinska Institutet
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Tobias Nordström, MD PhD, Karolinska Institutet Identifier: NCT02788825    
Other Study ID Numbers: STHLM3MR-1
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases