Zusammenfassung
Die intraprostatische Injektionstherapie stellt ein minimal-invasives Verfahren zur Behandlung des benignen Prostatasyndroms (BPS) dar und könnte bei zunehmend älteren und komorbiden Patienten eine Therapiealternative zu den klassischen Prostataoperationen sein. Als Applikationssubstanzen sind derzeit Botulinumneurotoxin A (BoNT/A), dehydriertes Ethanol, NX-1207 und PRX302 von Bedeutung. Für keine der Substanzen besteht eine Zulassung („off-label use“). Für BoNT/A existieren nur drei randomisierte, placebokontrollierte Studien (RCT), für dehydriertes Ethanol existiert keine RCT. Bisherige Ergebnisse für beide Substanzen sind widersprüchlich und ohne deutlichen Wirksamkeitsbeleg. NX-1207 ist ein Protein mit selektiven proapoptotischen Eigenschaften. Eine Nicht-Unterlegenheit zu Finasterid konnte gezeigt werden. PRX302 ist ein modifiziertes Proaerolysin, welches durch prostataspezifisches Antigen (PSA) aktiviert wird. PRX302 ist somit zellspezifisch. Sicherheit und Effektivität wurden belegt. Intraprostatische Injektionstherapien sollten derzeit, unabhängig von der verwendeten Substanz, ausschließlich im Rahmen klinischer Studien erfolgen.
Abstract
Intraprostatic injection therapy is a minimally invasive treatment of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia and could be a therapeutic alternative in increasingly older and co-morbid patients. Nowadays only botulinum neurotoxin A (BoNT/A), absolute ethanol, NX-1207 and PRX302 are of relevance but none of these substances has yet been authorized for treatment use (off-label use). There have been only three randomized, placebo-controlled trials (RCTs) for BoNT/A, whereas none exist for ethanol and the results of existing studies are inconsistent and without convincing proof of efficacy. NX-1207 is a protein with selective pro-apoptotic properties and non-inferiority compared to finasteride has been demonstrated. PRX302 is a modified proaerolysin that can be activated by prostate-specific antigen and is therefore (prostate) cell-specific. Safety and efficacy are well documented; however, intraprostatic injection therapy should presently only be performed in clinical trials, irrespective of the substance used.
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Interessenkonflikt
Der korrespondierende Autor weist auf folgende Beziehungen hin: T. Bschleipfer: Vorträge/Beraterfunktion für die Firmen Astellas Pharma GmbH, Pfizer Pharma GmbH, Bayer Health Care/Bayer Vital GmbH, Dr. R. Pfleger GmbH. Wissenschaftliche Kooperation mit Pharm Allergan GmbH. T. Bach: Vorträge für die Firma GlaxoSmithKline. C. Gratzke: Vorträge/Beraterfunktion für die Firmen Astellas Pharma GmbH, GlaxoSmithKline, Bayer Health Care/Bayer Vital GmbH, Lilly und Rottapharm Madaus GmbH. S. Madersbacher: Vorträge/Beraterfunktion für die Firmen Pharm Allergan GmbH, Astellas Pharma GmbH, Rottapharm Madaus GmbH, Pfizer Pharma GmbH. M. Oelke: Vorträge/Beraterfunktion und klinische Studien für die Firmen Apogepha, Astellas, Dr. Schwabe GmbH, GlaxoSmithKline, Ferring, Lilly, Pfizer, Sophiris und Recordati.
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Bschleipfer, T., Bach, T., Gratzke, C. et al. Intraprostatische Injektionstherapien beim benignen Prostatasyndrom. Urologe 52, 354–358 (2013). https://doi.org/10.1007/s00120-012-3091-3
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DOI: https://doi.org/10.1007/s00120-012-3091-3
Schlüsselwörter
- Botulinumneurotoxin A
- Ethanol, dehydriertes
- Injektion, intraprostatische
- Prostatasyndrom, benignes
- Symptome des unteren Harntrakts