PMID- 29661587 OWN - NLM STAT- MEDLINE DCOM- 20201102 LR - 20201102 IS - 2405-4569 (Electronic) IS - 2405-4569 (Linking) VI - 5 IP - 6 DP - 2019 Nov TI - Medium-term Follow-up of Vascular-targeted Photodynamic Therapy of Localized Prostate Cancer Using TOOKAD Soluble WST-11 (Phase II Trials). PG - 1022-1028 LID - S2405-4569(18)30092-0 [pii] LID - 10.1016/j.euf.2018.04.003 [doi] AB - BACKGROUND AND OBJECTIVE: To assess the medium-term tumor control in patients with localized prostate cancer (PCa) treated with vascular-targeted photodynamic (VTP) therapy with TOOKAD Soluble WST11 (VTP) and to assess the medium-term tolerability of the treatment. DESIGN, SETTING, PARTICIPANTS, AND INTERVENTION: During the clinical phase II studies, 68 patients were treated with VTP under optimal treatment conditions (WST11 at 4mg/kg, light energy at 200J/cm, and a light density index >/=1) and have been included in a 3.5-yr follow-up. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Post-interventional visits were scheduled every 6 mo and conducted as per local standard practice in each study center. Cancer-free status was assessed by means of prostate-specific antigen kinetics, multiparametric magnetic resonance imaging and/or prostate biopsies. RESULTS AND LIMITATIONS: At the end of the 3.5-yr follow-up, overall successful focal ablation was achieved for 51 patients (75%). Cancer was identified in the untreated lobe in 17 patients (25%). In total, 34 patients (50%) were cancer-free in both the prostate lobes. In case of recurrent/persistent malignancy, the Gleason score remained consistent or changed at the maximum by one point (upgrading by 1 Gleason point to 3+4 for eight patients and 4+3 for two patients). There were 64 related adverse events (AEs): 48% were Clavien grade I, 47% were grade II, and 5% were grade III. There were no Clavien grade IV and V AEs. Limitations included small sample size and heterogeneity in the follow-up for some centers. CONCLUSIONS: VTP is a safe and efficient treatment and represents an alternative option for localized low-risk PCa management over the medium term. Precise diagnostic methods and imaging tools are thereby essential requirements to ensure safe and complete targeted therapy. PATIENT SUMMARY: In this report, we looked at the medium-term outcomes of focal photodynamic therapy for early-stage prostate cancer. We found that this form of treatment is efficient and might have the potential to become a therapeutic option for low-risk cancer. Effectiveness depends on precise diagnostic methods, such as magnetic resonance imaging and accurate biopsy. CI - Copyright (c) 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved. FAU - Noweski, A AU - Noweski A AD - Department of Urology, Ludwig-Maximilians-University, Munich, Germany. FAU - Roosen, A AU - Roosen A AD - Department of Urology, Ludwig-Maximilians-University, Munich, Germany. Electronic address: a.roosen@augusta-bochum.de. FAU - Lebdai, S AU - Lebdai S AD - Department of Urology, University Hospital of Angers, France. FAU - Barret, E AU - Barret E AD - Department of Urology, Institut Montsouris, Paris, France. FAU - Emberton, M AU - Emberton M AD - Division of Surgery and Interventional Science, University College London, London, UK. FAU - Benzaghou, F AU - Benzaghou F AD - Medical Department, STEBA Biotech, Paris, France. FAU - Apfelbeck, M AU - Apfelbeck M AD - Department of Urology, Ludwig-Maximilians-University, Munich, Germany. FAU - Gaillac, B AU - Gaillac B AD - Medical Department, STEBA Biotech, Paris, France. FAU - Gratzke, C AU - Gratzke C AD - Department of Urology, Ludwig-Maximilians-University, Munich, Germany. FAU - Stief, C AU - Stief C AD - Department of Urology, Ludwig-Maximilians-University, Munich, Germany. FAU - Azzouzi, A R AU - Azzouzi AR AD - Department of Urology, University Hospital of Angers, France. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20180413 PL - Netherlands TA - Eur Urol Focus JT - European urology focus JID - 101665661 RN - 0 (Bacteriochlorophylls) RN - 0 (palladium-bacteriopheophorbide) RN - EC 3.4.21.77 (Prostate-Specific Antigen) RN - EEO29FZT86 (padeliporfin) SB - IM MH - Aged MH - Bacteriochlorophylls/administration & dosage/*therapeutic use MH - Biopsy MH - Combined Modality Therapy/methods MH - Follow-Up Studies MH - Humans MH - Male MH - Middle Aged MH - Molecular Targeted Therapy/methods MH - Multiparametric Magnetic Resonance Imaging/methods MH - Neoplasm Grading/methods MH - Photochemotherapy/adverse effects/*methods MH - Prostate/blood supply/pathology MH - Prostate-Specific Antigen/blood MH - Prostatic Neoplasms/blood supply/pathology/*therapy MH - Risk Assessment MH - Treatment Outcome OTO - NOTNLM OT - Focal therapy OT - Medium term follow-up OT - Padeliporfin OT - Prostate carcinoma OT - TOOKAD OT - Vascular-targeted therapy EDAT- 2018/04/18 06:00 MHDA- 2020/11/03 06:00 CRDT- 2018/04/18 06:00 PHST- 2018/01/29 00:00 [received] PHST- 2018/03/04 00:00 [revised] PHST- 2018/04/01 00:00 [accepted] PHST- 2018/04/18 06:00 [pubmed] PHST- 2020/11/03 06:00 [medline] PHST- 2018/04/18 06:00 [entrez] AID - S2405-4569(18)30092-0 [pii] AID - 10.1016/j.euf.2018.04.003 [doi] PST - ppublish SO - Eur Urol Focus. 2019 Nov;5(6):1022-1028. doi: 10.1016/j.euf.2018.04.003. Epub 2018 Apr 13.