Stockholm3 Use Prior to MRI for Prostate Cancer Detection... | NCT06573736

Studies
Stockholm3 Use Prior to MRI for Prostate Cancer Detection in a Clinical Care Pathway: a Multi-centered Validation

NCT06573736

Sponsor

Karolinska Institutet

Status

Not yet recruiting

Last Update Posted

Aug 27, 2024Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Stockholm3

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2024Estimated

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Aug 21, 2024

First Submission Date that Met QC Criteria

Aug 23, 2024

First Posted Date

Aug 27, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2024

Last Update Posted Date

Aug 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Men meeting local clinical standard of care to undergo a prostate MRI for suspicion of prostate cancer will be included. Blood sample will be drawn on the day of MRI or immediately prior to MRI for measurement of the prostate cancer biomarker Stockholm3. Specifically, the Stockholm3 test will be performed in a retrospective manner and no clinical decisions will be made based on the results. The patients will not receive the results of the Stockholm3 assay. A Stockholm3 score will be reported for each patient.

The primary aim is to show superior specificity of Stockholm3 (at different thresholds) for MRI selection compared to PSA (at different thresholds) (I.e., the proportion of men with a negative Stockholm3 test or a negative PSA test among those with a normal MRI).

Additional aims:

To show non-inferior relative sensitivity in detection of csPC of Stockholm3 compared to PSA (The proportion of men with a positive Stockholm3 test (at different thresholds) or a positive PSA test (at different thresholds) among those diagnosed with csPC will be calculated).
To evaluate Stockholm3 risk thresholds to determine if it can be used to further reduce MRI, biopsy and Gleason grade group 1 cancers without reducing sensitivity of csPC detection.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stockholm3	Diagnostic Test	Stockholm3 combines protein markers tPSA, fPSA, KLK2, PSP94 and GDF15, genetic markers and clinical data to estimate risk for clinically significant prostate cancer.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Abnormal MRI	PIRADS ≥3	From enrollment up to 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Clinically significant prostate cancer	Grade group ≥2 prostate cancer	From enrollment up to 24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men with age range (40.0 - 80.0 years)
Already scheduled to undergo MRI for prostate cancer screening (both negative and positive MRI included).

Exclusion Criteria:

PSA < 1.5 ng/mL
Any known diagnosis of prostate cancer (patient on active surveillance)
Men that have undergone digital rectal exam (DRE) immediately before blood draw (DRE within 5 days of study blood draw are excluded).
Men who in the three (3) months prior to study participation received any invasive urologic procedure such as thermotherapy, microwave therapy, laser therapy, transurethral resection of the prostate (TURP), urethral catheterization, and lower genitourinary tract endoscopy (cystoscopy)
No history of new treatment for BPH in three (3) months prior to study participation.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Men meeting local standard of care to undergo prostate MRI for suspicion of prostate cancer

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

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Browse Branches

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