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LHRH Sparing Therapy in Patients with Chemotherapy-Naïve, mCRPC Treated with Abiraterone Acetate plus Prednisone: Results of the Randomized Phase II SPARE Trial

BACKGROUND: Although the benefit of androgen deprivation therapy (ADT) continuation in metastatic castration-resistant prostate cancer (mCRPC) remains controversial, clinical evidence is lacking. Recent results indicated that treatment with abiraterone acetate (AA) plus prednisone (P) further suppresses serum testosterone levels over ADT alone, suggesting that continuation of ADT in the treatment of mCRPC may not be necessary.

METHODS: In this exploratory phase 2 study, mCRPC patients were randomized with a 1:1 ratio to receive either continued ADT plus AA + P (Arm A) or AA + P alone (Arm B). The primary endpoint was the rate of radiographic progression-free survival (rPFS) at month 12. Secondary endpoints included PSA-response rate, objective response, time to PSA progression and safety.

RESULTS: A total of 68 patients were equally randomized between the two study arms. Median testosterone-levels remained below castrate-levels throughout treatment in all patients. According to the intention-to-treat analysis the rPFS rate was 0.84 in Arm A and 0.89 in Arm B. Moderate and severe treatment-emergent adverse events were reported for 72% of the patients in Arm A and for 85% of the patients in Arm B.

CONCLUSIONS: AA + P treatment without ADT may be effective in mCRPC patients and ADT may not be necessary in patients receiving AA + P.

Carsten-Henning Ohlmann,1,2 Michelle Jäschke,1 Peter Jaehnig,3 Susanne Krege,4 Jürgen Gschwend,5 Heidrun Rexer,6 Kerstin Junker,1 Roger Zillmann,7 Christoph Rüssel,8 Eva Hellmis,9 Henrik Suttmann,10 Martin Janssen,1,11 Jan Marin,12 Andreas Hübner,13 Michael Mathers,14 Jochen Gleißner,15 Michael Scheffler,16 Susan Feyerabend,17 Jens Telle,18 Jörg Klier,19 and Michael Stöckle1

Department of Urology, Saarland University Medical Center, Homburg/Saar, Germany. 2 Department of Urology, Johanniter-Kliniken Bonn, Bonn, Germany. 3 pj statistics, Berlin, Germany. 4 Department of Urology, Evangelische Kliniken Essen Mitte, Essen, Germany. 5 Department of Urology, Klinikum Rechts der Isar, Technical University Munich, Munich, Germany. 6 Meckevidence, Schwarz, Germany. 7 Urologie Pankow, Berlin, Germany. 8 Urologie Borken, Borken, Germany. 9 Urologicum-Duisburg Fachärztesozietät, Duisburg, Germany. 10Urologikum Hamburg MVW, Hamburg, Germany. 11Department of Urology, University Münster, Münster, Germany. 12Urologie Kempen, Münster, Germany. 13Zentrum für Onkologie und Urologie, Rostock, Germany. 14Pandamed, Remscheid, Germany. 15Uro-Gyn-Praxis Am Wall, Wuppertal, Germany. 16Urologische Gemeinschaftspraxis, Zwickau, Germany. 17Studienpraxis Urologie, Nürtingen, Germany. 18Urologische Praxisgemeinschaft, Wolfsburg, Germany. 19Urologische Partnerschaft, Köln, Germany.

Source: Ohlmann C, Jäschke M, Jaehnig P et al. "LHRH Sparing Therapy in Patients with Chemotherapy-Naïve, mCRPC Treated with Abiraterone Acetate plus Prednisone: Results of the Randomized Phase II SPARE Trial." Prostate Cancer and Prostatic Diseases. 2022. https://doi.org/10.1038/s41391-022-00533-6