From PSA to Stockholm3: Study Part 1

Study Overview
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Brief Summary
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This part of the project aims to analyze the effectiveness of the Stockholm3 test in regular clinical practice, both in general practice and in the specialist health care, as a tool for detecting patients who need further diagnostics for prostate cancer.

Detailed Description
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Background: Prostate cancer constitutes about 15 % of new cases of cancer among men globally, but about 27 % of all new cases of cancer in men in Norway. It is also the leading cause of cancer death among men, and nearly 1100 Norwegian men died from prostate cancer in 2014. However, only about 30 percent of new cases have an aggressive form of the disease. Therefore, the challenge is to detect and distinguish patients with aggressive disease from patients who have a low risk cancer. The Prostate-Specific Antigen (PSA) is currently the main test used in primary care to detect and prioritize patients for further diagnostics. PSA is used for screening in many countries, but the Norwegian authorities consider the harms of using PSA for screening purposes (over-diagnosis and overtreatment) to outweigh the benefits (potentially reduced mortality). Nevertheless, it has been documented that a substantial amount of opportunistic PSA screening takes place in Norway. At present, a novel test called the Stockholm3 test has been developed. A large prospective study has shown that the efficacy of the Stockholm3 test is superior to PSA, and both the sensitivity and the specificity are substantially higher for Stockholm3 than for PSA. Aim The aim of this study is to analyze the effectiveness of the Stockholm3 test in regular clinical practice, including both primary care and specialized health care. Study Design From September 2017, the urological department at Stavanger University Hospital requires a Stockholm3 answer in referrals of patients for further diagnostics of possible prostate cancer. Comparable clinical data will be collected for a period before - and from a corresponding period after the Stockholm3 test was taken into use. An analysis will then be carried out where the results from the period where referrals were based primarily on PSA will be compared with the results for the period in which the Stockholm 3 test was used. Power calculation Based on results from the original Stockholm3 study and aggregated figures regarding PSA testing, prostate biopsies and MRI of the prostate in Stockholm and Stavanger, a statistical power has been calculated. Based on a two-sided alpha at 0.05 (i.e., 5%) and a 90% power the study need about 8000 participants to reliably answer the main study questions. An interim analysis will be conducted in the inclusion phase. A new power calculation will be performed based on the registered data, and the need of participants will be adjusted if necessary.

Official Title
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From PSA to Stockholm3, a Naturalistic Effectiveness Multipart Research Program: Study Part 1

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: PSA and Stockholm3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All men where a physicians in regular clinical work finds that there is an indication to take the test Exclusion Criteria: known prostate cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: PSA and Stockholm3|The new Stockholm3 test and traditional PSA test|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of prostate cancer with Gleason score ≥ 7 / Gleason score ≤ 6 | The percentage of patients whose prostate biopsies showed a Gleason score ≤ 6 or ≥7 among those referred for diagnostics based on a PSA test or a Stockholm3 test | 9 to 12 months from september 2017 compared with a corresponding period one year earlier | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of prostate biopsies among patients tested with PSA and Stockholm3 | The percentage of patients referred for further diagnosis of potential prostate cancer with biopsy among those who were tested with PSA over a period of time, compared to those tested with Stockholm3 for a corresponding period of time | 9 to 12 months from september 2017 compared with a corresponding period one year earlier | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnostics, over-diagnosis