Clinical trial NCT04627948: STHLM3 AS NorDCaP - a Followup Study of Men on Active Surveillance of Prostate Cancer
Official title: STHLM3 AS NorDCaP - a Followup Study of Men on Active Surveillance of Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Active Surveillance
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Helse Stavanger HF
name: University of Aarhus
name: Mehiläinen, Finland
name: Capio Sankt Görans Hospital
First posted: 2020-11-13
Enrollment: 199
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Validate if the Stockholm3 test can be used in an AS cohort to predict upgrading
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
state: Solna
Study officials:
References: