Randomized phase-II trial of abiraterone acetate plus LHRH

Randomized phase-II trial of abiraterone acetate plus LHRH

08.03.2013
Randomized phase-II trial of abiraterone acetate plus LHRHtherapy versus abiraterone acetate sparing LHRH-therapy in
patients with progressive chemotherapy-naïve castrationresistant
prostate
cancer
(SPARE).
AUO
Carsten‐H. Ohlmann
67/11
Hormone therapy of PCa
LHRH-Analoga/
Antagonisten
ZNS
Hoden
Testosteron
Testosteron
Tumorzelle
Hormone therapy of PCa
LHRH-Analoga/
Antagonisten
ZNS
Abirateron
Abirateron
Nebenniere
Hoden
Testosteron
Testosteron
Abirateron
Testosteron
Tumorzelle
Testosterone-independent effects of LH
LHRH-Analoga/
Antagonisten
ZNS
Abirateron
LH
Abirateron
LH
Nebenniere
Hoden
Testosteron
Testosteron
Abirateron
Testosteron
Tumorzelle
LH/LH‐receptor expression in PCA cells
Pinski et al. The Prostate 71:892‐898 (2011) LH stimulation of LNCaP cells
Pinski et al. The Prostate 71:892‐898 (2011) Randomized phase-II trial of abiraterone acetate plus LHRH-therapy
versus abiraterone acetate sparing LHRH-therapy in patients with
progressive chemotherapy-naïve castration-resistant prostate cancer
(SPARE)
Abiraterone 1000mg
Prednisone 2x5mg
LHRH-Therapie
Progressive
chemotherapy naive
CRPC
(70 Pts, 12 Zentren)
Randomisation 1:1
Abiraterone 1000mg
Prednisone 2x5mg
Primärer Endpunkt: radiographisch progressions-freies Überleben (rPFS)
Sekundäre Endpunkte: PSA-Ansprechen, PSA-progressions-freies Überleben,
Toxizität, Effekt auf Hypophysen-Gonaden-Achse
Randomized phase-II trial of abiraterone acetate plus LHRH-therapy
versus abiraterone acetate sparing LHRH-therapy in patients with
progressive chemotherapy-naïve castration-resistant prostate cancer
(SPARE)
Bewertung durch die EK:
First patient first visit:
Last patient enrolled:
Last patient last visit:
Interimsanalyse nach 35 Patienten:
Abschlussbericht:
April 2013
Mai 2013
Mai 2014
Sep 2015
Nov 2014
Jan 2016
Weitere Projekte...?
[email protected]
08.03.2013
Danke!
Carsten‐H. Ohlmann