Randomized phase II trial of neoadjuvant androgen deprivation therapy plus abiraterone and apalutamide for patients with high-risk localized prostate cancer: Pathologic response and PSMA imaging correlates.

• DOI: 10.1200/jco.2022.40.16_suppl.5085
• Publication Date: 2022-06-06T16:28:08Z
• Authors: Diogo Assed Bastos; Rafael Coelho; Leonardo Cardili; Felipe Galiza; Eder Nisi Ilario; Públio Viana; Claudio Bovolenta...; Giuliano Guglielm...; Mauricio Cordeiro; Jose Pontes Jr; David Queiroz Bor...; Jamile Almeida Silva; Jose Mauricio Mota; Guilherme Fialho ...; Katia Ramos Morei...; Carlos Alberto Bu...; William Carlos Nahas
• Keywords: Clinical endpoint; Abiraterone acetate; Neoadjuvant Therapy; Biochemical recurrence

5085 Background: Patients (pts) with high-risk localized prostate cancer (HRLPC) have a significant risk of disease recurrence and metastasis after radical prostatectomy (RP). Neoadjuvant therapy remains investigational but there may be role for the next-generation androgen signaling inhibitors. We sought to evaluate pathologic imaging response intense neoadjuvant approach. Methods: This is phase II investigator-initiated randomized trial 3-month goserelin (androgen deprivation therapy, ADT) + abiraterone acetate prednisone (AAP arm) or AAP apalutamide (A-APA before RP pts HRLPC (Gleason ≥ 8 and/or cT3N0-1 PSA 20 ng/mL). The primary endpoint was rate complete (pCR) minimal residual (MRD, tumor ≤ 0.5 cm). secondary endpoints were safety, burden ≤0.25 cm 3 (RCB = volume x cellularity), Gallium 68 prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/magnetic resonance correlates biochemical relapse (BR). Results: Sixty-two A-APA (N 31) 31). Median age 65 (range 47-77) years. NCCN groups included in 19%, very 76% regional (N1) 5% (79% cT3, 65% Gleason 8-10, 57% Outcomes ADT are described Table. There no statistically difference between study arms regarding pCR/MRD RCB 0.25 rates. PSMA-PET (psmaCR) demonstrated 50% compared 7.5% without psmaCR ( P= 0.001). BR 14% versus 38% > 0.118). At current median follow-up 2.6 years, all patients both 0.25cm 11, 18%) free BR. 2 grade (G) 5 adverse events (AEs) arm (pulmonary embolism sudden death, surgery). Nine (14.5%) (6 A-APA; AAP) experienced G3-4 treatment-related AEs. most common AEs hypertension (11.3%), AST/ALT elevations (3.2%) skin rash (1.6%). Conclusions: No pCR MRD observed arms. Although infrequent, proportion achieved favorable . potential surrogate response. Clinical information: NCT02789878. [Table: see text]