Paros-Studie zum Prostatakarzinom

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Zusammenfassung der Studienziele

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Primärer Endpunkt

Verbesserte QoL bezüglich Rektum-assoziierter Symptome durch die Verwendung einer hypofraktionierten Protonen-RT (QLQ PR 25); Differenz 12 Wochen – Baseline. Die Studie ist eine multizentrische, prospektive, dreiarmige Phase-III-Studie.
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Sekundäre Endpunkte

Nicht-Unterlegenheit hinsichtlich bPFS der hypofraktionierten Therapiearme im Vgl. zum Standardarm nach 5 Jahren
OS nach 5 Jahren
Allgemeine Lebensqualität (EORTC QLQ C30) nach 2 und 5 Jahren
Toxizität (CTCAE Version 5.0) nach 2 und 5 Jahren

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Ablauf und Teilnahmevoraussetzungen

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Die PAROS-Studie ist eine Phase III Studie, die insgesamt 897 Patienten an mehrere Zentren in Deutschland einschließen wird. Allen Patienten mit Prostatakarzinomen, bei denen eine Bestrahlung nach erfolgter Operation des Prostatakarzinoms notwendig ist und die gleichzeitig die Studienkriterien erfüllen, wird eine Studienteilnahme angeboten. Unsere Praxis wird Patienten im Münchener Raum rekrutieren, die Koordination der Studie läuft über die Abteilung für Strahlentherapie und Radioonkologie des Universitätsklinikums Heidelberg.

Im Rahmen der PAROS-Studie sollen drei verschiedene Radiotherapieansätze direkt miteinander verglichen werden. Hierbei variieren sowohl die Bestrahlungsdauer (19 oder 35 Bestrahlungstage), die Bestrahlungsdosis pro Tag (2 Gy oder 3 Gy), als auch die Bestrahlungsart (Photonen (Röntgenstrahlen) oder Protonen (Wasserstoffionen)). Die sog. biologische, also wirksame Strahlendosis, welche am Ende im Gewebe ankommt unterscheidet sich jedoch gemäß strahlenbiologischer Rechenmodelle nicht. Im Einzelnen handelt es sich um folgende drei mögliche Therapiearme:

Die leitlinien-gerechte Standardbehandlung mit 35 Bestrahlungstagen mit Photonen in moderner IMRT (intensitätsmodulierte Radiotherapie) Technik = Arm 1
Eine verkürzter Gesamtbehandlungszeit mit 19 Bestrahlungstagen mit Photonen in moderner IMRT Technik = Arm 2
Eine verkürzter Gesamtbehandlungszeit mit 19 Bestrahlungstagen mit Protonen = Arm 3

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Vorherige Arbeiten am Universitätsklinikum Heidelberg konnten bereits in einarmigen Studien zeigen, dass eine Verkürzung der Bestrahlungszeit über 3,5 Wochen mittels Photonen (PRIAMOS-Studie, 18 Bestrahlungstage) oder auch Protonen (PROLOG-Studie, 18 Bestrahlungstage) hinsichtlich der Erfolgsrate und Nebenwirkungsrate vergleichbar ist. Ziel der Studie ist es, Lebensqualität, Effektivität und Nebenwirkungsraten zu vergleichen.

Die Bestrahlung mit Photonen (Arme 1 und 2) würde in unserer Praxis am Maximiliansplatz in München stattfinden. Die Protonenbestrahlung (Arm 3) würde im Heidelberger IonenTherapiezentrum (HIT) erfolgen.

Sollten Sie Interesse an der Teilnahme dieser Studie haben, können Sie sich gerne einen Termin für ein Beratungsgespräch unter 089-552528-50 vereinbaren.
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Einschlusskriterien

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Histologisch gesichertes Prostatakarzinom mit feingeweblicher Einteilung gemäß Gleason-Score und vorliegendem PSA-Wert
Indikation zur Bestrahlung der Prostataloge (adjuvant/ Salvage) nach erfolgter Prostatektomie
Karnofsky-Index ≥ 70%

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Alter ≥ 18 Jahren
Durchgeführte Patientenaufklärung und schriftliche Einwilligung
Einwilligungsfähigkeit des Patienten

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Ausschlusskriterien

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Antihormonelle Therapie
Lymphogene Metastasierung – makroskopischer Tumor / R2
Stadium IV (Fernmetastasen) – vorangegangene Strahlentherapie im Becken

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Hüft-TEP
Gleichzeitige Teilnahme an einer anderen klinischen Studie, die die Ergebnisse der jeweiligen Studie beeinflussen könnte

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Weiterführende Informationen

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