1. Padeliporfin vascular-targeted photodynamic therapy versus active surveillance in men with low-risk prostate cancer (CLIN1001 PCM301): an open-label, phase 3, randomised controlled trial
- Author
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Antonio Alcaraz, Henk G. van der Poel, Georg Salomon, Eduardo Solsona, Billy Amzal, Christian Gratzke, Derek J. Rosario, Mark Emberton, Francisco Gomez-Veiga, Abdel Rahmene Azzouzi, Frans M.J. Debruyne, F. Benzaghou, Teuvo T. L. Tammela, Antony Cicco, Christian G. Stief, Bertrand Gaillac, Sébastien Vincendeau, Gaëlle Fromont, Eric Barret, Göran Ahlgren, François Kleinclauss, Jens Rassweiler, Service d'urologie, Université d'Angers (UA)-Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Service d'urologie [Rennes] = Urology [Rennes], Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'urologie [Institut Mutualiste Montsouris], Institut Mutualiste de Montsouris (IMM), Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) (RIGHT), Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS BFC)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Service d'urologie, andrologie et transplantation rénale, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Hôpital Saint-Jacques, LA-SER Europe Ltd, Laboratoire d'Anatomo-Pathologie, CHU de Poiters, UCLH/UCL Comprehensive Biomedical Centre, University College London Hospitals (UCLH), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Franche-Comté (UFC), and Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])
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Adult ,Male ,medicine.medical_specialty ,030232 urology & nephrology ,[SDV.CAN]Life Sciences [q-bio]/Cancer ,[SDV.MHEP.UN]Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology ,Risk Assessment ,law.invention ,03 medical and health sciences ,Prostate cancer ,0302 clinical medicine ,Randomized controlled trial ,Prostate ,law ,Internal medicine ,Medicine ,Humans ,Adverse effect ,Bacteriochlorophylls ,Aged ,Neoplasm Staging ,Aged, 80 and over ,Intention-to-treat analysis ,Photosensitizing Agents ,medicine.diagnostic_test ,business.industry ,Hazard ratio ,Cancer ,Prostatic Neoplasms ,Rectal examination ,Middle Aged ,medicine.disease ,Prognosis ,3. Good health ,Surgery ,Survival Rate ,medicine.anatomical_structure ,Oncology ,Photochemotherapy ,030220 oncology & carcinogenesis ,Population Surveillance ,[SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology ,Neoplasm Grading ,business ,Follow-Up Studies - Abstract
International audience; BACKGROUND: Vascular-targeted photodynamic therapy, a novel tissue-preserving treatment for low-risk prostate cancer, has shown favourable safety and efficacy results in single-arm phase 1 and 2 studies. We compared this treatment with the standard of care, active surveillance, in men with low-risk prostate cancer in a phase 3 trial.METHODS: This randomised controlled trial was done in 47 European university centres and community hospitals. Men with low-risk, localised prostate cancer (Gleason pattern 3) who had received no previous treatment were randomly assigned (1:1) to vascular-targeted photodynamic therapy (4 mg/kg padeliporfin intravenously over 10 min and optical fibres inserted into the prostate to cover the desired treatment zone and subsequent activation by laser light 753 nm with a fixed power of 150 mW/cm for 22 min 15 s) or active surveillance. Randomisation was done by a web-based allocation system stratified by centre with balanced blocks of two or four patients. Best practice for active surveillance at the time of study design was followed (ie, biopsy at 12-month intervals and prostate-specific antigen measurement and digital rectal examination at 3-month intervals). The co-primary endpoints were treatment failure (histological progression of cancer from low to moderate or high risk or death during 24 months' follow-up) and absence of definite cancer (absence of any histology result definitely positive for cancer at month 24). Analysis was by intention to treat. Treatment was open-label, but investigators assessing primary efficacy outcomes were masked to treatment allocation. This trial is registered with ClinicalTrials.gov, number NCT01310894.FINDINGS: Between March 8, 2011, and April 30, 2013, we randomly assigned 206 patients to vascular-targeted photodynamic therapy and 207 patients to active surveillance. Median follow-up was 24 months (IQR 24-25). The proportion of participants who had disease progression at month 24 was 58 (28%) of 206 in the vascular-targeted photodynamic therapy group compared with 120 (58%) of 207 in the active surveillance group (adjusted hazard ratio 0·34, 95% CI 0·24-0·46; p
- Published
- 2016
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