Clinical trial NCT03381105: From PSA to Stockholm3: Study Part 1
Official title: From PSA to Stockholm3, a Naturalistic Effectiveness Multipart Research Program: Study Part 1
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Keywords: Diagnostics, over-diagnosis
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2017-12-21
Enrollment: 13431
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All men at risk of prostate cancer in the 18 municipalities covered by Stavanger University Hospital

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of prostate cancer with Gleason score ≥ 7 / Gleason score ≤ 6
timeFrame: 9 to 12 months from september 2017 compared with a corresponding period one year earlier
Secondary outcomes:
measure: Rate of prostate biopsies among patients tested with PSA and Stockholm3
timeFrame: 9 to 12 months from september 2017 compared with a corresponding period one year earlier
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: Helse Stavanger HF
name: Svein Kjosavik, MS PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gronberg H, Adolfsson J, Aly M, Nordstrom T, Wiklund P, Brandberg Y, Thompson J, Wiklund F, Lindberg J, Clements M, Egevad L, Eklund M. Prostate cancer screening in men aged 50-69 years (STHLM3): a prospective population-based diagnostic study. Lancet Oncol. 2015 Dec;16(16):1667-76. doi: 10.1016/S1470-2045(15)00361-7. Epub 2015 Nov 10.