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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Sweden

Capio St Görans Hospital

Stockholm, Sweden

GHP Odenplan Urology

Stockholm, Sweden

Sophiahemmet Urology

Stockholm, Sweden

Sponsors and Collaborators

Karolinska Institutet

Investigators

• Principal Investigator: Tobias Nordström, MD PhD; Karolinska Institutet

More Information

Additional Information:

Study homepage 

Publications:

Nordstrom T, Picker W, Aly M, Jaderling F, Adolfsson J, Strom P, Haug ES, Eklund M, Carlsson S, Gronberg H. Detection of Prostate Cancer Using a Multistep Approach with Prostate-specific Antigen, the Stockholm 3 Test, and Targeted Biopsies: The STHLM3 MRI Project. Eur Urol Focus. 2017 Dec;3(6):526-528. doi: 10.1016/j.euf.2017.01.014. Epub 2017 Mar 28.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nordstrom T, Discacciati A, Bergman M, Clements M, Aly M, Annerstedt M, Glaessgen A, Carlsson S, Jaderling F, Eklund M, Gronberg H; STHLM3 study group. Prostate cancer screening using a combination of risk-prediction, MRI, and targeted prostate biopsies (STHLM3-MRI): a prospective, population-based, randomised, open-label, non-inferiority trial. Lancet Oncol. 2021 Sep;22(9):1240-1249. doi: 10.1016/S1470-2045(21)00348-X. Epub 2021 Aug 13.

Eklund M, Jaderling F, Discacciati A, Bergman M, Annerstedt M, Aly M, Glaessgen A, Carlsson S, Gronberg H, Nordstrom T; STHLM3 consortium. MRI-Targeted or Standard Biopsy in Prostate Cancer Screening. N Engl J Med. 2021 Sep 2;385(10):908-920. doi: 10.1056/NEJMoa2100852. Epub 2021 Jul 9.

Nordstrom T, Jaderling F, Carlsson S, Aly M, Gronberg H, Eklund M. Does a novel diagnostic pathway including blood-based risk prediction and MRI-targeted biopsies outperform prostate cancer screening using prostate-specific antigen and systematic prostate biopsies? - protocol of the randomised study STHLM3MRI. BMJ Open. 2019 Jun 14;9(6):e027816. doi: 10.1136/bmjopen-2018-027816.

• 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
• Last Update Posted: December 14, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases