SPCG17: Prostate Cancer Active Surveillance Trigger Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

Active surveillance: Active monitoring of prostate cancer and curative treatment if there are signs of tumor progression.

Study summary

A large proportion of men with prostate cancer are overdiagnosed and overtreated mainly due to PSA testing. Active surveillance (AS) aims to reduce these harms by recommending curative treatment only when and if signs of tumor progression occur. There are however a number of uncertainties in AS, the most important being when to initiate treatment. The investigators are therefore starting a large randomized multicenter trial testing the safety of a standardized active surveillance protocol with specified triggers for repeat biopsies and initiation of curative treatment. The standardized protocol is compared with current practice for active surveillance. The primary aim of the study is to reduce overtreatment and subsequent side effects, without increasing the risk of disease progression or prostate cancer mortality.

Eligibility

Primary outcome measure(s)

• Progression-free survival — Median 10 years follow-up
  Disease progression is defined as 1) cumulative incidence of PSA relapse after curative treatment or 2) cumulative incidence of androgen deprivation therapy in untreated men still in active surveillance.

Trial sites (23)

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