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Title [sv]
PCBaSe Xtend; Stigfinnarprojekt för berikning av forskningsdatabas med patientdata från Sveriges regioner
Title [en]
PCBaSe Xtend; Pathfinder project for enrichment of a research database with individual-level healthcare data
Abstract [sv]
Prostatacancer är den vanligaste cancern i Sverige. Screening för prostatacancer  är kontroversiell eftersom effekten på prostatacancerdöd varit måttligt stark i randomiserade studier och tidig behandling ofta medför biverkningar som sänker livskvalité.Män med prostatacancer av lågrisktyp har en mycket lång förväntad överlevnad så det behövs upp till 40 års uppföljning innan den fulla effekten av screening och efterföljande behandling kan värderas med konventionell studiedesign. Därför behövs statistisk modellering för att beräkna långtidsutfall av olika screeningstrategier. Detta kräver longitudinella data från stora populationsbaserade kohorter.I Sverige kan sådana kohorter skapas genom att länka nationella hälsodataregister och kvalitetsregister men tyvärr saknar dessa register flera variabler som är nödvändiga för att kunna studera screening för prostatacancer.Det som behövs i tillägg till de data som finns i hälsoregistren är longitudinella data för prostata-specifikt antigen (PSA) och resultat av magnetresonansundersökning av prostata (som nyligen blivit förstahandsundersökning vid förhöjt PSA) och cancergrad på prostatabiopsi och användning av kemoterapi. Dessa data finns tillgängliga i hälsovårdens IT-system.Sekundäranvändning av hälsodata är ett av Regeringen liksom EU prioriterat område som bedöms ha en stor potential. Därför finns ett behov att undersöka om sekundäranvändning av hälsodata är praktiskt genomförbart och vilken kvalité extraherad data har.I detta stigfinnarprojekt skapar vi PCBaSe Xtend genom att extrahera patientdata från alla svenska regioners IT-system. PCBaSe Xtend kommer att innehålla data från Nationella prostatacancerregistret, andra nationella hälsoregister och demografiska databaser och individdata från regionernas IT-system. I en pilotstudie har vi på ett strukturerat sätt extraherat data från alla IT-system i åtta regioner. Vi fann att data-extraktion är möjlig och att täckning och datakvalité var god.  PCBaSe Xtend kommer att bli en nationell, populationsbaserad kohort med longitudinella data för 250 000 män med prostatacancer och över fyra miljoner män utan prostatacancer. Genom att tillämpa statistisk modellering på data i PCBaSe Xtend kommer vi att undersöka konsekvenser av olika strategier för PSA-testning och behandling på långtidsutfallet för män med prostatacancer.
Abstract [en]
Population-based screening with prostate-specific antigen (PSA) testing for prostate cancer, the most common cancer in Sweden, is not recommended since benefits have not been shown to outweigh adverse effects from overdiagnosis and overtreatment. This balance may now be shifting, by use of magnetic resonance imaging (MRI) of the prostate a new diagnostic tool, and of active surveillance as treatment strategy for low-risk cancer. However, the benefit-risk balance is difficult to evaluate due to the long latency phase before diagnosis and the several decade-long disease course. A very long follow-up with longitudinal data is required to assess all relevant effects of screening and new treatments. Conventional study methods cannot generate timely results to guide public health policy decisions.In Sweden there is a unique possibility to link national health registers, but longitudinal data on laboratory and imaging results (PSA, MRI, biopsy) and hospital medications (hormonal therapy and chemotherapy) are not available in any of these national registers. Such data must be extracted directly from healthcare.The purpose of this project is to extract individual-level patient data from all 21 regions in Sweden on these critical variables. The project is in line with the Government’s efforts to facilitate secondary use of healthcare data and EU initiatives such as the European health data space (EHDS). In our pathfinder project PCBaSe Xtend, individual-level patient data from routine healthcare from all 21 Swedish regions will be combined with data from The National Prostate Cancer Register and other national registers.Project feasibility has been verified in a subset of regions, where we have established a detailed administrative strategy, extracted  targeted data from all IT systems in use, and found good data coverage and quality. Several hurdles, but also their remedies, have already been identified. The project will deliver generalizable strategies for secondary use of healthcare data as well as internationally unique statistical models of prostate cancer screening and long-term outcomes.PCBaSe Xtend will be a nationwide, population-based cohort with comprehensive longitudinal data on 250 000 prostate cancer cases and more than 4 million men not diagnosed with prostate cancer. We will use PCBaSe Xtend for advanced statistical modelling of the effects of various prostate cancer screening and treatment strategies on  long-term disease outcomes.  
Publications (2 of 2) Show all publications
Scilipoti, P., Callenmark, M., Garmo, H., Stattin, P., Gedeborg, R. & Westerberg, M. (2026). Estimation and Prognostic Role of Prostate-specific Antigen (PSA) Doubling Time After Radical Prostatectomy. European Urology Open Science, 89, 1-9
Open this publication in new window or tab >>Estimation and Prognostic Role of Prostate-specific Antigen (PSA) Doubling Time After Radical Prostatectomy
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2026 (English)In: European Urology Open Science, ISSN 2666-1691, E-ISSN 2666-1683, Vol. 89, p. 1-9Article in journal (Refereed) Published
Abstract [en]

Background and objective

There are several methods for estimating prostate-specific antigen (PSA) doubling time (DT), and many men exhibit long periods of undetectable PSA below 0.1 ng/ml after radical prostatectomy (RP). We quantified between-method differences in estimated PSA-DT at PSA relapse after RP and evaluated how these differences affect discrimination of prostate cancer (PCa) death.

Methods

Men who underwent RP in 2007–2024 and subsequently developed a PSA relapse, defined as two consecutive values above 0.2 ng/ml, were included. We estimated PSA-DT from the date of the first undetectable PSA after RP until PSA relapse using four methods: (1) all detectable PSAs only, (2) two most recent detectable PSAs, (3) three most recent PSAs (with the third forced to 0.1 ng/ml if ≤0.1 ng/ml), and (4) all PSAs using a missing data approach. Discrimination of 10-yr PCa death was assessed using concordance index (C-index).

Key findings and limitations

A total of 3826 men were included. Median PSA-DT ranged from 4.4 to 8.6 mo, with a wide range in PSA-DT across different estimation methods. All four methods discriminated PCa death to a similar level, with C-index ranging from 0.70 to 0.74, which was slightly lower than the C-index (0.77) for the absolute PSA level at relapse. This study was restricted to men with PSA relapse after RP and may not be generalizable to other patient categories.

Conclusions and clinical implications

PSA-DT after RP was sensitive to the choice of estimation method, and all methods had comparable prognostic value to the last measured PSA level.

Place, publisher, year, edition, pages
Elsevier, 2026
Keywords
Stats Editor:, Doubling time, Detection limit, Prostate-specific antigen, Prostate cancer, Radical prostatectomy
National Category
Cancer and Oncology
Identifiers
urn:nbn:se:uu:diva-592511 (URN)10.1016/j.euros.2026.05.006 (DOI)001781329900001 ()42222855 (PubMedID)2-s2.0-105039292930 (Scopus ID)
Funder
Swedish Research Council, 2022-00544Swedish Cancer Society, 22 2051Forte, Swedish Research Council for Health, Working Life and Welfare, 2024-01652
Available from: 2026-06-26 Created: 2026-06-26 Last updated: 2026-06-26Bibliographically approved
Galdieri, A., Garmo, H., Gedeborg, R., Ahlberg, M., Wilberg Orrason, A., Ventimiglia, E., . . . Westerberg, M. (2026). Temporal trends in diagnostic work-up, treatment, and mortality in locally advanced prostate cancer in 2016-2024: nationwide, population-based study in Sweden. Acta Oncologica, 65, 282-288
Open this publication in new window or tab >>Temporal trends in diagnostic work-up, treatment, and mortality in locally advanced prostate cancer in 2016-2024: nationwide, population-based study in Sweden
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2026 (English)In: Acta Oncologica, ISSN 0284-186X, E-ISSN 1651-226X, Vol. 65, p. 282-288Article in journal (Refereed) Published
Abstract [en]

Background and purpose: We aimed to describe temporal changes in diagnostic work-up, treatment, and prostate cancer (PCa) mortality in locally advanced PCa in 2016–2024 in Sweden.

Patient/material and methods: Men registered in the National Prostate Cancer Register of Sweden in 2016–2024 with locally advanced PCa; clinical T stage 3–4, no distant metastases, and prostate-specific antigen < 100 ng/ml were included. We computed the proportion of use of prostate magnetic resonance imaging (MRI) before biopsy, radical prostatectomy, radical radiotherapy, androgen deprivation therapy, and abiraterone, and described the trend in PCa mortality across three calendar periods.

Results: During the 9-year study period 7,484 men with locally advanced PCa were identified. Use of MRI before biopsy increased from 3% in 2016 to 73% in 2024. Concomitantly, radical treatment increased from 35% to 48%, entirely due to increased use of radiotherapy. Abiraterone was not used before 2022 but 31% received this treatment in 2024. The 3-year PCa mortality decreased from 8% (95% confidence interval [CI]: 7–9) in 2016–2018 to 6% (95% CI: 4–8) in 2022–2024.

Interpretation: In this nationwide, population-based study of men with locally advanced PCa, the use of MRI before biopsy, radical radiotherapy, and treatment with abiraterone increased over time. These changes coincided with a modest decrease in 3-year PCa mortality.

Place, publisher, year, edition, pages
MJS Publishing, 2026
Keywords
Locally advanced prostate cancer, treatment, mortality, diagnosis, staging
National Category
Cancer and Oncology Urology
Identifiers
urn:nbn:se:uu:diva-591760 (URN)10.2340/ao.v65.45593 (DOI)001786595300001 ()41983270 (PubMedID)
Available from: 2026-06-23 Created: 2026-06-23 Last updated: 2026-06-23Bibliographically approved
Principal InvestigatorStattin, Pär
Gedeborg, Rolf
Westerberg, Marcus
Garmo, Hans
Coordinating organisation
Uppsala University
Funder
Period
2024-12-10 - 2025-11-30
National Category
Cancer and Oncology
Identifiers
DiVA, id: project:9145Project, id: 2024-01652_Forte

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