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Completed

NCT Number: NCT04627948

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

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.

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Key information

Age range

40 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

Karolinska Institutet

Stockholm, Solna, 17177, Sweden

About this study

STHLM3 AS NorDCaP is a cross-sectional multi-center study, evaluating the predictive value of Stockholm3 test in a prostate cancer cohort on AS for upgrading on rebiopsy. Men from the study sites, diagnosed with prostate cancer and currently on AS and planned for rebiopsies will be invited to the study. Eligible individuals have to be alive without any severe comorbidity and without a history of initiating treatment; surgery, radiation, hormone therapy or chemotherapy. To avoid the need for additional investigations, sampling will be synchronized with timing for planned follow-up within the AS program for each individual.

At baseline blood will be drawn for Stockholm3 analyses. The patient will be asked to fill out an informed consent. For each man the following data will be collected: Stockholm3 Risk Score, Stockholm3 Prostate Volume cut-off, total PSA, DRE status, MRI results (PI-RADS, optional, only if MRI is conducted within 3 months before biopsy), prostate volume, biopsy results (ISUP, cancer length, number of positive cores, total number of cores and stage).

Main outcome measurement will be number of upgrading, i.e. number of detected ISUP ≥ 2 cancers.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Through study completion, an average of 1 year

    Number of ISUP ≥ 2 prostate cancer

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Capio Sankt Görans Hospital
  • Helse Stavanger HF
  • Mehiläinen, Finland
  • University of Aarhus

Registry information

Acronym: NorDCaP AS

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Nov 13, 2020
Registry last updated
Jan 21, 2025

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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