Trial reportProstate cancer and prostatic diseases2026
Neoadjuvant pamiparib plus abiraterone and androgen deprivation therapy for high-risk/very high-risk localized prostate cancer: an open-label, single-arm, phase 2 study.
Trial report in Prostate cancer and prostatic diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundAndrogen receptor signaling inhibition (ARPI) increases genomic instability of double-stranded DNA breaks, and co-inhibition of androgen receptor (AR) and poly(ADP-ribose) polymerase (PARP) induces synthetic lethality in multiple preclinical models. This phase II study evaluated the efficacy, safety, and quality-of-life (QoL) impact of neoadjuvant pamiparib plus abiraterone and androgen deprivation therapy (ADT) in patients with high-risk or very high-risk localized prostate cancer (HRPCa/VHRPCa).
methodsIn this single-arm trial, patients with HRPCa/VHRPCa, defined as Gleason score ≥8, and/or cT3-4N0-1, and/or PSA ≥ 20 ng/mL, received pamiparib plus abiraterone and ADT for 4 months before radical prostatectomy (RP). The primary endpoint was pathological complete response (pCR; no residual tumor) or minimal residual disease (MRD; ≤5 mm residual tumor). Secondary endpoints included PSA response, surgical downstaging, 2-year biochemical progression-free survival (bPFS), QoL metrics, and safety.
resultsThirty patients were enrolled; 29 completed therapy and underwent RP. Median age was 65 years, and 9 patients had enlarged pelvic lymph nodes. Homologous recombination repair (HRR) mutations were detected in 7 patients. Overall, 8 patients (28%) achieved pCR or MRD (pCR in 3 [10%], MRD in 5 [17%]), and 18 patients (62%) had surgical downstaging, with no progression events. No significant difference in pCR or MRD rates was observed between patients with HRR mutations and those without HRR mutations. Two-year bPFS was 76%. FACT-P scores improved in 18 patients (62%) during therapy, with 9 of 22 (41%) maintaining improvement postoperatively. At 12 months, mean EPIC-26 urinary incontinence score was 83.2 ± 12.5. No grade 3-4 treatment-related adverse events occurred; common grade 1-2 events were anemia (45%), elevated AST/ALT (34%), and hypertriglyceridemia (45%).
conclusionsNeoadjuvant pamiparib plus abiraterone and ADT demonstrated efficacy, safety, and potential QoL benefits in HRPCa/VHRPCa.
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