{"entity":{"id":"nct01310894","kind":"trial","name":"Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance","aka":["PCM301","CLIN1001 PCM301","TOOKAD Soluble phase 3"],"tldr":"A phase 3 trial of Padeliporfin in Prostate cancer, run by Steba Biotech S.A., completed.","summary":"Efficacy and Safety Study of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance is a phase 3 interventional study registered as NCT01310894 by Steba Biotech S.A., with 413 participants recorded, started 2011-02 and reaching its primary completion in 2015-06. Interventions recorded: TOOKAD® Soluble. Conditions recorded: Prostate Cancer.\n\nLinked to the drug Padeliporfin because the registry names it among its interventions and Prostate cancer among its conditions. Registry record only: no result has been read by an editor.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT01310894","url":"https://clinicaltrials.gov/study/NCT01310894"},{"label":"PCM301 padeliporfin against active surveillance (Lancet Oncology 2017)","url":"https://doi.org/10.1016/S1470-2045(16)30661-1"},{"label":"NICE TA546: padeliporfin for untreated localised prostate cancer, not recommended","url":"https://www.nice.org.uk/guidance/ta546"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","prostate-low-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["padeliporfin"],"companies":["steba-biotech"],"institutions":[],"pathways":[],"terms":["prostate-focal-therapy"],"trials":["protect"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["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.\n\nThe 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."],"nct":"NCT01310894","phase":"3","setting":"A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance","sponsor":"Steba Biotech S.A.","result":"Disease progression at 24 months in 28 percent after padeliporfin vascular-targeted photodynamic therapy against 58 percent under active surveillance (adjusted hazard ratio 0.34, 95 percent confidence interval 0.24 to 0.46); negative biopsy at 24 months in 49 against 14 percent. NICE TA546 does not recommend the treatment in England.","started":"2011-02","yearReported":2017,"enrolled":413,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease progression at 24 months","primary":true,"unit":"%","arms":[{"name":"Padeliporfin vascular-targeted photodynamic therapy","n":206,"value":28,"note":"Adjusted hazard ratio; progression defined as histological progression from low to moderate or high risk, or death."},{"name":"Active surveillance","n":207,"value":58}],"hr":0.34,"ci":[0.24,0.46],"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(16)30661-1"},{"endpoint":"Negative prostate biopsy at 24 months","primary":true,"unit":"%","arms":[{"name":"Padeliporfin vascular-targeted photodynamic therapy","n":206,"value":49,"note":"Adjusted risk ratio 3.67 (95 percent confidence interval 2.53 to 5.33)."},{"name":"Active surveillance","n":207,"value":14}],"p":"<0.0001","source":"https://doi.org/10.1016/S1470-2045(16)30661-1"}],"replication":"No independent randomised replication; it remains the only phase 3 comparison of a focal therapy against active surveillance in prostate cancer."},"route":"/trials/nct01310894/","neighbours":{"cancer":[{"id":"prostate-low-risk","kind":"cancer","name":"Localised prostate cancer, very low and low risk","route":"/cancers/prostate-low-risk/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"drug":[{"id":"padeliporfin","kind":"drug","name":"Padeliporfin","route":"/drugs/padeliporfin/"}],"company":[{"id":"steba-biotech","kind":"company","name":"Steba Biotech","route":"/companies/steba-biotech/"}],"term":[{"id":"prostate-focal-therapy","kind":"term","name":"Focal and tissue-preserving treatment of prostate cancer","route":"/terms/prostate-focal-therapy/"}],"trial":[{"id":"protect","kind":"trial","name":"ProtecT","route":"/trials/protect/"}]}}