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Sökning: onr:"swepub:oai:lup.lub.lu.se:1335bb66-c38a-4c61-b1b2-e099af7ada1e" > Padeliporfin vascul...

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

Azzouzi, Abdel Rahmène (författare)
CHU Angers
Vincendeau, Sébastien (författare)
Rennes University Hospital
Barret, Eric (författare)
Paris Descartes University
visa fler...
Cicco, Antony (författare)
Centre d'Urologie et Andrologie
Kleinclauss, François (författare)
Centre Hospitalier Universitaire de Besancon
van der Poel, Henk G. (författare)
Stief, Christian G. (författare)
University Hospital Munich
Rassweiler, Jens (författare)
SLK-Kliniken
Salomon, Georg (författare)
University Medical Center Hamburg-Eppendorf
Solsona, Eduardo (författare)
Instituto Valenciano de Oncologia
Alcaraz, Antonio (författare)
Hospital Clínic of Barcelona
Tammela, Teuvo T. (författare)
Tampere University Hospital
Rosario, Derek J. (författare)
Royal Hallamshire Hospital
Gomez-Veiga, Francisco (författare)
University Hospital la Coruna
Ahlgren, Göran (författare)
Lund University,Lunds universitet,Urologisk cancerforskning, Malmö,Forskargrupper vid Lunds universitet,Urological cancer, Malmö,Lund University Research Groups,Skåne University Hospital
Benzaghou, Fawzi (författare)
Steba Biotech
Gaillac, Bertrand (författare)
Steba Biotech
Amzal, Billy (författare)
LASER Analytica
Debruyne, Frans M J (författare)
Andros Men's Health Institutes
Fromont, Gaëlle (författare)
University Hospital of Tours
Gratzke, Christian (författare)
University Hospital Munich
Emberton, Mark (författare)
Royal Free Hospital
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 (creator_code:org_t)
Elsevier, 2017
2017
Engelska.
Ingår i: The Lancet Oncology. - : Elsevier. - 1470-2045. ; 18:2, s. 181-191
  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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  • 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<0·0001). 101 (49%) men in the vascular-targeted photodynamic therapy group had a negative prostate biopsy result at 24 months post treatment compared with 28 (14%) men in the active surveillance group (adjusted risk ratio 3·67, 95% CI 2·53-5·33; p<0·0001). Vascular-targeted photodynamic therapy was well tolerated. The most common grade 3-4 adverse events were prostatitis (three [2%] in the vascular-targeted photodynamic therapy group . vs one [<1%] in the active surveillance group), acute urinary retention (three [2%] . vs one [<1%]) and erectile dysfunction (two [1%] . vs three [1%]). The most common serious adverse event in the vascular-targeted photodynamic therapy group was retention of urine (15 patients; severe in three); this event resolved within 2 months in all patients. The most common serious adverse event in the active surveillance group was myocardial infarction (three patients). Interpretation: Padeliporfin vascular-targeted photodynamic therapy is a safe, effective treatment for low-risk, localised prostate cancer. This treatment might allow more men to consider a tissue-preserving approach and defer or avoid radical therapy. Funding: Steba Biotech.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine (hsv//eng)

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