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Prostate Cancer Detection Using the Stockholm3 Test and MR/Fusion Biopsies (STHLM3MR-2)

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ClinicalTrials.gov Identifier: NCT03377881
Recruitment Status : Completed
First Posted : December 19, 2017
Last Update Posted : December 14, 2020
Sponsor:
Information provided by (Responsible Party):
Tobias Nordström, Karolinska Institutet

Brief Summary:
STHLM3-MR Phase 2 is a study comparing traditional prostate cancer detection using PSA and systematic biopsies with the improved pipeline for prostate cancer detection using the STHLM3 test and targeted biopsies in a screening context.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: MRI/Fusion biopsies Procedure: Systematic biopsies Not Applicable

Detailed Description:

The overarching strategy of the STHLM3-MR/Fusion projects are to study an improved diagnostic pipeline including an improved blood-based test for identification of men with increased risk of prostate cancer and use of MRI to select men for diagnostic workup with targeted prostate biopsies. The aim is to increase the specificity in early detection of prostate cancer without decreasing the sensitivity of aggressive prostate cancers.

The primary endpoints are the number of performed biopsies, the number of performed MRI and the number of detected high-risk prostate cancers. 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 and development of automated image-analysis.

The STHLM3-MR project is performed in two separate phases, analyzed separately. STHLM3-MR Phase 1 closed inclusion 2017-06-01. All participants underwent target and systematic biopsies together with STHLM3 test analysis. The study is constitutes a current practice cohort and levels of the STHLM3 test were not used for selecting participants.

STHLM3-MR Phase 2 is a study comparing traditional prostate cancer detection using PSA and systematic biopsies with the improved pipeline for prostate cancer detection using the STHLM3 test and targeted biopsies in a screening context.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-step design with a first step using paired design for blood-analysis and a second step using randomisation between prostate biopsy strategy.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: STHLM3 MR Phase 2: A New Diagnostic Chain for Prostate Cancer Detection Using the Stockholm3 Test and MR/Fusion Biopsies
Actual Study Start Date : April 4, 2018
Actual Primary Completion Date : December 10, 2020
Actual Study Completion Date : December 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Traditional
The traditional/control arm consists of PSA testing and if PSA>3ng/ml a systematic biopsy of the prostate is performed.
Procedure: Systematic biopsies
The intervention in the control arm is traditional systematic biopsies of the prostate.

Experimental: STHLM3+MRI/Fusion
The experimental arm consists of a Stockholm3 bloodiest and if elevated, an MRI is recommended with targeted biopsies to prostate lesions.
Procedure: MRI/Fusion biopsies
The intervention in the experimental arm is an MRI with targeted biopsies using fusion technique to prostate lesions.




Primary Outcome Measures :
  1. Number of detected cancers characterized as Gleason Score ≥7 on evaluation of biopsy specimen [ Time Frame: At 2 months after study closure (last included biopsy procedure) ]
    Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm


Secondary Outcome Measures :
  1. Number of detected cancer with Gleason Score 6 [ Time Frame: At 2 months after study closure (last included biopsy procedure) ]
    Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm

  2. Number of performed biopsy procedures in the study arms [ Time Frame: At 2 months after study closure (last included biopsy procedure) ]
    Number of performed prostate biopsy procedures counted per study arm

  3. Number of performed MRI in the study arms [ Time Frame: At 2 months after study closure (last included biopsy procedure) ]
    Number of performed prostate MRI procedures counted per study arm

  4. Number of infectious complications [ Time Frame: Questionnaire collection finalised within 2months after last biopsy procedure in study ]
    As assessed by questionnaire within 2 month after biopsy procedure



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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Permanent postal address in Stockholm

Exclusion Criteria:

  • • 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 ClinicalTrials.gov identifier (NCT number): NCT03377881


Locations
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Sweden
Capio St Görans Hospital
Stockholm, Sweden
GHP Odenplan Urology
Stockholm, Sweden
Sophiahemmet Urology
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Tobias Nordström, MD PhD Karolinska Institutet
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tobias Nordström, Urologist PhD Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03377881    
Other Study ID Numbers: STHLM3MR-2
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases