Therapie mit ¹⁷⁷Lu-PSMA: Stand der Dinge

Zusammenfassung

¹⁷⁷Lu-PSMA Radiopharmaka wurden in den letzten Jahren als fester Bestandteil der Behandlung des kastraktionsresistenten, metastasierten, progredienten Prostatakarzinoms etabliert. Zahlreiche deutsche Institutionen hatten hieran maßgeblichen Anteil. Eine retrospektive deutsche Multicenter Studie zeigte, dass die ¹⁷⁷Lu-PSMA-Therapie effektiv und sicher ist. Zwar fand die ¹⁷⁷Lu-PSMA-Therapie Eingang in die S3 Leitlinie zur Behandlung des Prostatakarzinoms, soll jedoch in der letzten Linie nach Ausschöpfen der empfohlenen Therapieoptionen erfolgen. Da keine zugelassenen ¹⁷⁷Lu-PSMA Radiopharmaka verfügbar sind, ist die Behandlung nur in Ausübung der ärztlichen Heilkunde gemäß § 13 2b des Arzneimittelgesetztes möglich. Derzeit laufen mehrere teils globale prospektive, randomisierte Studien, die bei positivem Ergebnis eine Zulassung ermöglichen werden. Es wird ¹⁷⁷Lu-PSMA Monotherapie im Vergleich zu „best supportive care“ (Vision Studie) und im Vergleich zu Carbazitaxel (TheraP Studie) getestet. Zudem werden Kombinationstherapien mit Pembrolizumab (PRINCE Studie) oder Olaparib (LuPARP Studie) in Phase I/II Studien geprüft. Vom Ausgang dieser Studien wird die zukünftige Rolle des ¹⁷⁷Lu-PSMA abhängen.

Abstract

¹⁷⁷Lu-PSMA is novel treatment option for castration resistant, metastasized, progressive prostate cancer. A number of German institutions have played a vital role in establishment of this radiopharmaparmaceutical. A first retrospective multicenter trial showed that ¹⁷⁷Lu-PSMA is effective and safe in treatment of metastasized prostate cancer. ¹⁷⁷Lu-PSMA is recommended by the German guidelines as a last line option for prostate cancer treatment. On the other hand, so far ¹⁷⁷Lu-PSMA is not approved by EMA and German authoriies and its clinical use is restricted to the framework of § 13 2b of the German Pharmaceuticals Act. Currently a number of international, prospective randomized clinical trials are being performed that may lead to a global approval of ¹⁷⁷Lu-PSMA radiopharmaceuticals by EMA and FDA. 177Lu-PSMA monotherapy is tested compared to best supportive care (Vision trial) or Carbazitaxel (TheraP trial). Moreover, combinations with the checkpoint inhibitor Pembrolizumab (PRINCE trial) or Olaparip are currently tested. The results of these trials will shape the future of ¹⁷⁷Lu-PSMA therapy.

Schlüsselwörter

¹⁷⁷Lu-PSMA - Prostatakarzinom - Radiopharmaka

Key Words

¹⁷⁷Lu-PSMA - Prostate Cancer - Radiopharmaceutical

• Literatur

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