SPCG-17 Prostate Cancer Active Surveillance Threshold Study (PCASTS): A multicenter randomized trial
Widespread PSA testing of asymptomatic men has dramatically increased the recorded incidence of prostate cancer in many western countries. It is now widely accepted that a large proportion of these men are over-diagnosed – because they have non-lethal disease – and over-treated with substantial side effects. To reduce overtreatment and adverse effects, active surveillance has emerged as a viable option that should be offered to patients with low risk prostate cancer.
By monitoring disease progression – or lack thereof – and keeping the option to recommend radical local treatment open for a certain period of time, active surveillance might convey substantial benefits compared with routine initial prostatectomy. This management strategy is, however, complicated by the lack of randomized evidence for when disease progression should trigger radical treatment with a curative intent. The decision to switch from active surveillance to aggressive therapeutic intervention is therefore in the clinical practice of today triggered by evidence of progression chosen rather arbitrarily.
To fill this problematic knowledge gap, the Scandinavian Prostatic Cancer Group has promoted a large multicenter randomized trial – SPCG-17 Prostate Cancer Active Surveillance Trigger Trial (PCASTT). With the primary endpoint set to progression-free survival, the aim of this trial is to test the safety of an active surveillance protocol that uses standardized triggers for initiation of curative treatment. The study hypothesis is that standardized triggers will reduce overtreatment without increasing disease progression and prostate cancer mortality, compared with current practice. Both trial arms are followed-up every six months with PSA test and with an annual clinical check-up (including PSA test). Every second year, the participants will be examined with MRI with targeted biopsies at suspicious lesions.
The study is based on a protocol evolved – in consultation with SPCG and all participating centers – by Hans-Olov Adami, Anna Bill-Axelson and Lars Holmberg. Enrollment begun in October 2016 in Uppsala and around ten Swedish hospitals are involved in the study. In addition, several centres in Denmark, Norway, Finland, and the UK, will join.
Other projects in which Hans-Olov Adami is deeply involved are based at the University of Oslo and can be found the Norwegian website http://www.med.uio.no/helsam/english/research/groups/clinical-effectiveness/
Participants: Anna Bill-Axelson (PI), Hans-Olov Adami, Lars Holmberg
Financing: The Swedish Research Council