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NCT Number: NCT03377881

Prostate Cancer Detection Using the Stockholm3 Test and MR/Fusion Biopsies

The STHLM3-MRI trial 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.

The study includes individualised repeat invitations for re-screening to participants not diagnosed with prostate cancer.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year–74 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

C-medical Odenplan Urology, Stockholm, Sweden

Loading trial locations.

About this study

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. STHLM3-MR Phase 2 reported outcomes from the first screening round 2023. Repeated screening with individualised screening intervals will be offered to participants without prostate cancer detected.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI/Fusion biopsies

Procedure

The intervention in the experimental arm is an MRI with targeted biopsies using fusion technique to prostate lesions. Repeat screening is offered after 2-6 years on an individualised basis.

systematic biopsies

Procedure

The intervention in the control arm is traditional systematic biopsies of the prostate.

Primary outcomes

  1. Number of detected cancers characterized as Gleason Score ≥7 on evaluation of biopsy specimen

    Time frame: At 2 months after completing first screening round (included biopsy procedure). At two months after completing repeat screening rounds ( year 3, 6, 9, 12 and 15).

    Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm

Secondary outcomes

  1. Number of detected cancer with Gleason Score 6

    Time frame: At 2 months after completing first screening round (last included biopsy procedure). At two months after completing repeat screening rounds ( year 3, 6, 9, 12 and 15).

    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 completing first screening round (last included biopsy procedure). At two months after completing repeat screening rounds ( year 3, 6, 9, 12 and 15).

    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 completing first screening round (last included biopsy procedure). At two months after completing repeat screening rounds ( year 3, 6, 9, 12 and 15).

    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

  5. Distribution of MRI findings in men positive for Stockholm3 and/or PSA

    Time frame: At 2 months after completing first screening round (last included biopsy procedure). At two months after completing repeat screening rounds ( year 3, 6, 9, 12 and 15).

    Distribution of PI-RADS (Prostate Imaging-Reporting and Data System; 1-5; 5=clinically significant cancer is highly likely to be present) scores among men undergoing an MRI

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

STHLM3 MR Phase 2: A New Diagnostic Chain for Prostate Cancer Detection Using the Stockholm3 Test and MR/Fusion Biopsies

Acronym: STHLM3MR-2

Important dates

Study start
2018
Primary completion
2020
Study completion
2030
First posted
Dec 19, 2017
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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