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

Prostate Cancer Clinical Trial

— NorDCaP AS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04627948
• Other study ID #: 2019-02020
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Karolinska Institutet
• Contact: Anna Lantz, MD PhD
• Phone: +46735016565
• Email: anna.lantz[@]sll.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Stockholm3 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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm	Solna

Sponsors (5)

Lead Sponsor	Collaborator
Karolinska Institutet	Capio Sankt Görans Hospital, Helse Stavanger HF, Mehiläinen, Finland, University of Aarhus

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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