SPCG-17: När aktiv monitorering bör övergå i botande behandling vid prostatacancer - en randomiserad studie jämförande dagens praxis med standardiserade kriterier för behandling

Tidsperiod: 2017-01-01 till 2019-12-31

Projektledare: Anna Bill-Axelson

Medarbetare: Lars Holmberg, Hans-Olov Adami

Finansiär: Vetenskapsrådet

Bidragstyp: Stöd till forskningsmiljö

Budget: 9 853 021 SEK

BackgroundA large proportion of men with prostate cancer are overdiagnosed and overtreated with substantial side effects, mainly due to widespread prostate-specific antigen (PSA) testing. Active surveillance (AS) aims to reduce these harms by recommending curative treatment only when and if signs of tumour progression occur. There are however some uncertainties with AS, the most important being the lack of evidence from randomized studies for when disease progression should trigger curative treatment.PopulationScandinavian and British men with untreated low-risk or favourable intermediate-risk prostate cancer eligible for AS with at least 10 years expected survival. InterventionStandardized triggers (by magnetic resonance imaging or pathological progression) for curative treatment. ComparatorCurrent practicePrimary endpointProgression-free survivalSecondary endpointsCumulative incidence of curative treatment, cumulative incidence of switch to watchful waiting, quality of life (by questionnaire), and health-related costsFinal endpoint at 10 yearsCumulative incidence of prostate cancer mortalitySignificanceThe trial aims to reduce overtreatment and improve the quality of life for men who are on AS, without increasing disease progression or prostate cancer mortality. Standardized triggers will also enable follow-up by nurses (which gives a better continuity for the patient), equalize prostate cancer care, and make AS a safe alternative to immediate treatment.