Karolinska Institutet
Stockholm, Solna, 17177, Sweden
NCT Number: NCT04627948
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.
Looking for future studies?
Notify Me40 year–75 year
Male
Observational
Stockholm, Solna, 17177, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Through study completion, an average of 1 year
Number of ISUP ≥ 2 prostate cancer
Karolinska Institutet
Other
Acronym: NorDCaP AS
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.
Published trials that share one or more normalized conditions with this study.
NCT03269422
Genital Diseases, Genital Diseases, Male
Basking Ridge, New Jersey, United States
View Trial DetailsNCT05754658
Breast Cancer, Breast Diseases
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT03606837
Genital Diseases, Genital Diseases, Male
Bordeaux, France
View Trial DetailsNCT06540794
Genital Diseases, Genital Diseases, Male
Istanbul, Turkey (Türkiye)
View Trial Details