NCT05294627

Brief Summary

The purpose of this study is to collect blood samples to investigate the prognostic performance of the STHLM3 test in a population of Swiss and German men suspected of harbouring prostate cancer based on a combination of elevated PSA levels (e.g. \>2.5 ng/ml) and/or pathological digital rectal examination and/or MRI-findings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

2.8 years

First QC Date

March 14, 2022

Last Update Submit

December 11, 2023

Conditions

Prostate CancerLocalized Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Cancer detection

    Correlation between Stockholm3 and histological diagnosis of prostate cancer

    2020-2022

Secondary Outcomes (1)

  • Disease state

    2020-2022

Interventions

Stockholm3DIAGNOSTIC_TEST

Stockholm3 test prior to prostate biopsy. Prostate biopsy is preformed irrespective of the Stockholm3 score.

Eligibility Criteria

Age18 Years - 99 Years
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Men with suspicion of prostate cancer (usually due to a combination of elevated PSA levels \[e.g. \>2.5 ng/ml\] and/or pathological digital rectal examination and/or MRI-findings)

You may qualify if:

  • Planned prostate biopsy due to suspicion of prostate cancer (usually due to a combination of elevated PSA levels \[e.g. \>2.5 ng/ml\] and/or pathological digital rectal examination and/or MRI-findings)
  • Written informed consent by the participant

You may not qualify if:

  • Severe anemia (Hb \<60g/l)
  • Previously already established diagnosis of prostate cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel, Urology

Basel, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples (2x10ml)

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Ashkan Mortezavi

    Universitätsspital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2022

First Posted

March 24, 2022

Study Start

January 1, 2020

Primary Completion

November 1, 2022

Study Completion

October 1, 2023

Last Updated

December 12, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)