Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance

Overview

• PCM301 randomised 413 men with low-risk, Gleason pattern 3 localised prostate cancer at 47 European university centres and community hospitals between 8 March 2011 and 30 April 2013. Treatment was 4 mg/kg padeliporfin intravenously over 10 minutes with optical fibres inserted into the prostate and activated by 753 nm laser light at a fixed 150 mW/cm for 22 minutes 15 seconds. Active surveillance followed best practice at the time of design: biopsy at 12-month intervals with PSA and digital rectal examination every 3 months. Median follow-up was 24 months. The commonest grade 3 to 4 adverse events after treatment were prostatitis (three men, 2 percent, against one under surveillance), acute urinary retention (three, 2 percent, against one) and erectile dysfunction (two, 1 percent, against three). The commonest serious adverse event after treatment was urinary retention in 15 men, severe in three, resolving within 2 months in all (Lancet Oncology 2017).
• NICE TA546 does not recommend padeliporfin within its marketing authorisation for untreated, unilateral, low-risk prostate cancer. The committee's stated reasoning was that long-term studies show men with low-risk disease live as long under active surveillance, that radical therapies carry long-term severe side effects, and that better diagnostics now identify low-risk disease more accurately.