936 Tookad ® Soluble (Padeliporfin) Second Generation Vascular Targeted Photodynamic Therapy (Vtp) for Prostate Cancer: Safety and Feasibility

Arumainayagam, Nimalan; Allen, Christopher; Moore, CM; Barber, Nicola; Hindley, Richard; Muir, Gordon; Trachtenberg, John; Cormier, Laurent; Barret, E.; Azzouzi, A.R.; Villers, Arnauld; Emberton, Mark

doi:10.1016/s1569-9056(10)60916-5

Cited by 9 publications

(3 citation statements)

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“…In a study of 40 men with no previous treatment for PCa, early results showed no significant side effects. 31 Recently, a manufacturer-sponsored Phase III RCT comparing VTP with AM in 413 men with very low-risk disease has been published with 2-year follow-up data. 20 It found VTP to be safe and effective, with a 66% reduced risk of treatment failure (adjusted hazard ratio 0.34, 95% confidence interval 0.24 to 0.46) compared with AM; however, the VTP group experienced more frequent and severe side effects, although these were mostly mild and of short duration.…”

Section: Vascular-targeted Photodynamic Therapymentioning

confidence: 99%

Partial ablation versus radical prostatectomy in intermediate-risk prostate cancer: the PART feasibility RCT

Hamdy

Elliott

Conte

et al. 2018

Health Technol Assess

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Background Prostate cancer (PCa) is the most common cancer in men in the UK. Patients with intermediate-risk, clinically localised disease are offered radical treatments such as surgery or radiotherapy, which can result in severe side effects. A number of alternative partial ablation (PA) technologies that may reduce treatment burden are available; however the comparative effectiveness of these techniques has never been evaluated in a randomised controlled trial (RCT). Objectives To assess the feasibility of a RCT of PA using high-intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) for intermediate-risk PCa and to test and optimise methods of data capture. Design We carried out a prospective, multicentre, open-label feasibility study to inform the design and conduct of a future RCT, involving a QuinteT Recruitment Intervention (QRI) to understand barriers to participation. Setting Five NHS hospitals in England. Participants Men with unilateral, intermediate-risk, clinically localised PCa. Interventions Radical prostatectomy compared with HIFU. Primary outcome measure The randomisation of 80 men. Secondary outcome measures Findings of the QRI and assessment of data capture methods. Results Eighty-seven patients consented to participate by 31 March 2017 and 82 men were randomised by 4 May 2017 (41 men to the RP arm and 41 to the HIFU arm). The QRI was conducted in two iterative phases: phase I identified a number of barriers to recruitment, including organisational challenges, lack of recruiter equipoise and difficulties communicating with patients about the study, and phase II comprised the development and delivery of tailored strategies to optimise recruitment, including group training, individual feedback and ‘tips’ documents. At the time of data extraction, on 10 October 2017, treatment data were available for 71 patients. Patient characteristics were similar at baseline and the rate of return of all clinical case report forms (CRFs) was 95%; the return rate of the patient-reported outcome measures (PROMs) questionnaire pack was 90.5%. Centres with specific long-standing expertise in offering HIFU as a routine NHS treatment option had lower recruitment rates (Basingstoke and Southampton) – with University College Hospital failing to enrol any participants – than centres offering HIFU in the trial context only. Conclusions Randomisation of men to a RCT comparing PA with radical treatments of the prostate is feasible. The QRI provided insights into the complexities of recruiting to this surgical trial and has highlighted a number of key lessons that are likely to be important if the study progresses to a main trial. A full RCT comparing clinical effectiveness, cost-effectiveness and quality-of-life outcomes between radical treatments and PA is now warranted. Future work Men recruited to the feasibility study will be followed up for 36 months in accordance with the protocol. We will design a full RCT, taking into account the lessons learnt from this study. CRFs will be streamlined, and the length and frequency of PROMs and resource use diaries will be reviewed to reduce the burden on patients and research nurses and to optimise data completeness. Trial registration Current Controlled Trials ISRCTN99760303. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 52. See the NIHR Journals Library website for further project information.

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Section: Vascular-targeted Photodynamic Therapymentioning

confidence: 99%

Partial ablation versus radical prostatectomy in intermediate-risk prostate cancer: the PART feasibility RCT

Hamdy

Elliott

Conte

et al. 2018

Health Technol Assess

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“…These options include cryotherapy, 5,6 which is currently considered as an alternative option by the European Association of Urology (EAU) and American Urological Association (AUA) guidelines. [7][8][9] Other focal therapy options comprise experimental modalities such as high-intensity focused ultrasound (HIFU), [10][11][12] photodynamic therapy, 13,14 brachytherapy, irreversible electroporation (IRE), and focal laser ablation. 15,16 While the clinical data to date has confirmed the potential for these emerging techniques to provide higher benefit-to-risk ratio in localised PrC, most of these options are thermal options using energy to target cancerous cells, thus possibly generating tissue damage.…”

Section: Introductionmentioning

confidence: 99%

Pushing the Limits with Nanoknife®: A Promising New Technology in Localised Prostate Cancer Management

Charles¹,

Rosette

Emberton

2015

EMJ Allergy Immunol

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“…Necrosis was observed by MRI in 87% of the treated lobe. Regarding complications, two patients had prostatitis, one haematuria, one orchitis, one optic neuropathy, and one urethral stenosis [42]. …”

Section: Current Situationmentioning

confidence: 99%

ecancermedicalscience

Jácome-Pita

Sánchez-Salas

Barret

et al.

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Prostate cancer is one of the most significant pathologies in the field of urology. The adoption of screening strategies and improvements in biopsies have resulted in an increase in early-stage tumour detection.Radical global therapies provide very good oncological results in localised prostate cancer. However, excess treatment in low- and, in some cases, intermediate-risk groups affects the quality of life of these patients.In the case of localised prostate cancer, focal therapies offer a minimally invasive option with good results with respect to established treatments. Although this is currently not a standard treatment, it represents the therapeutic approach with the greatest potential.This literature review has the following objectives: to define selection criteria for patients who are candidates for focal therapy, to assess the current situation and results of the different therapeutic options, and to define procedures in cases of recurrence and for follow-ups.We concluded that focal therapy is a viable therapeutic alternative for localised prostate cancer, specifically cryosurgery and high-intensity targeted ultrasound, which have acceptable oncologic results and a lower comorbidity compared with global treatments. Studies with a high level of scientific evidence are still needed to validate these results.Acquisition of evidenceA search was carried out on the Medline (PubMed), EMBASE, Web of Science and Cochrane databases of all papers published before 31 July 2013. We included clinical studies and literature reviews that evaluated primary focal therapy for prostate cancer confirmed by biopsy and excluded focal rescue therapy studies. The keywords used were focal therapy and prostate cancer.Initially, we found 42 articles; 15 studies were excluded because they did not meet the minimum criteria for inclusion. A total of 1350 cases were treated throughout 27 studies.

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936 Tookad ® Soluble (Padeliporfin) Second Generation Vascular Targeted Photodynamic Therapy (Vtp) for Prostate Cancer: Safety and Feasibility

Cited by 9 publications

References 0 publications

Partial ablation versus radical prostatectomy in intermediate-risk prostate cancer: the PART feasibility RCT

Partial ablation versus radical prostatectomy in intermediate-risk prostate cancer: the PART feasibility RCT

Pushing the Limits with Nanoknife®: A Promising New Technology in Localised Prostate Cancer Management

ecancermedicalscience

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