STHLM3 AS NorDCaP - a Followup Study of Men on Active Surveillance of Prostate Cancer

NCT04627948 | Completed

• 1 other identifier: 2019-02020
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the STHLM3 AS NorDCaP study is to evaluate the Stockholm3 test in an active surveillance cohort to predict upgrading on rebiopsy. The study follows a paired design, evaluating our proposed protocol for follow up men on active surveillance with Stockholm3 versus the standard protocol according to national guidelines with PSA.

Conditions

Prostate Cancer

Keywords

Active Surveillance

Outcome Measures

Primary Outcomes (1)

• Validate if the Stockholm3 test can be used in an AS cohort to predict upgrading

  Number of ISUP ≥ 2 prostate cancer

  Through study completion, an average of 1 year

Interventions

Stockholm3 test DIAGNOSTIC_TEST

Diagnostic test: Stockholm3-test. Men from the study sites, diagnosed with prostate cancer and currently on AS and planned for rebiopsies will be invited to the study.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men diagnosed with low-risk PC, currently on AS and planned for follow-up with biopsies from the different inclusion sites will be invited to the study. Potential participants will be invited to the study by their urologist at their yearly follow up.

You may qualify if:

• Men diagnosed with low-risk PC and currently on AS and planned for follow-up with systematic and/or fusion biopsies as following standard of care.

You may not qualify if:

• History of treatment for prostate cancer; surgery, radiation, chemotherapy or hormonal treatment.
• Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia

Sponsors & Collaborators

• Karolinska Institutet: lead
• Helse Stavanger HF: collaborator
• University of Aarhus: collaborator
• Mehiläinen, Finland: collaborator
• Capio Sankt Görans Hospital: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, Solna, 17177, Sweden

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD Principal Investigator

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 13, 2020
• Study Start: July 1, 2019
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: January 21, 2025

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)