Neoadjuvant Cabazitaxel plus Abiraterone/Leuprolide Acetate in Patients with High-Risk Prostate Cancer: ACDC-RP Phase II Trial

Author:

Fleshner Neil E.1ORCID,Sayyid Rashid K.1ORCID,Hansen Aaron R.2ORCID,Chin Joseph L.K.3ORCID,Fernandes Ricardo4ORCID,Winquist Eric4ORCID,van der Kwast Theodorus5ORCID,Sweet Joan5ORCID,Lajkosz Katherine6ORCID,Kenk Miran1ORCID,Hersey Karen1ORCID,Veloso Rosette1ORCID,Berlin Doron1ORCID,Herrera-Caceres Jaime O.1ORCID,Sridhar Srikala2ORCID,Moussa Madeleine7ORCID,Finelli Antonio1ORCID,Hamilton Robert J.1ORCID,Kulkarni Girish S.1ORCID,Zlotta Alexandre R.8ORCID,Joshua Anthony M.9ORCID

Affiliation:

1. 1Division of Urologic Oncology, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.

2. 2Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.

3. 3Department of Surgery, Division of Urology, Western University, London, Ontario, Canada.

4. 4Department of Oncology, Division of Medical Oncology, Schulich School of Medicine and Dentistry, London Health Sciences Centre, Western University, London, Ontario, Canada.

5. 5Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada.

6. 6Department of Biostatistics, University of Toronto, Toronto, Ontario, Canada.

7. 7Department of Pathology and Laboratory Medicine, Western University, London, Ontario, Canada.

8. 8Department of Surgery, Urology, Sinai Health System, Toronto, Ontario, Canada.

9. 9Kinghorn Cancer Centre, St Vincent's Hospital, Garvan Institute of Medical Research, Sydney, Australia.

Abstract

Abstract Purpose: Early treatment intensification with neoadjuvant therapy may improve outcomes in patients with high-risk, localized prostate cancer treated with radical prostatectomy. Our objective was to compare pathologic, oncologic, and safety outcomes of neoadjuvant abiraterone acetate plus leuprolide acetate with or without cabazitaxel prior to radical prostatectomy in patients with localized, high-risk prostate cancer. Patients and Methods: This open-label, multicenter, phase II trial randomized men with clinically localized, D'Amico high-risk prostate cancer to neoadjuvant abiraterone acetate (1,000 mg/day) and leuprolide acetate (22.5 mg every 3 months) with or without cabazitaxel (25 mg/m2) prior to radical prostatectomy. The primary outcome was pathologic complete response (pCR) or minimal residual disease (MRD). Secondary outcomes included surgical margins, lymph node involvement, pathologic stage, 12-month biochemical relapse-free survival (BRFS) rates, and safety profile. Results: The per-protocol population consisted of 70 patients [cabazitaxel arm (Arm A): 37, no cabazitaxel arm (Arm B): 33]. Median patient age and prostate-specific antigen levels were 63.5 years [interquartile range (IQR), 58.0–68.0] and 21.9 ng/mL (IQR, 14.6–42.8), respectively. pCR/MRD occurred in 16 (43.2%) versus 15 patients (45.5%) in arms A and B, respectively (P = 0.85). pCR occurred in two (5.4%) versus three patients (9.1%) in arms A and B, respectively (P = 0.66). Patients with ≤ 25% total biopsy cores positive had increased odds of pCR/MRD (P = 0.04). Patients with pCR/MRD had superior 12-month BRFS rates (96.0% vs. 62.0%, P = 0.03). Grade 3+ adverse events occurred in 42.5% and 23.7% of patients in arms A and B, respectively (P = 0.078). Conclusions: Neoadjuvant cabazitaxel addition to abiraterone acetate/leuprolide acetate prior to radical prostatectomy did not improve pCR/MRD in clinically localized, high-risk prostate cancer.

Funder

Ontario Institute for Cancer Research

Publisher

American Association for Cancer Research (AACR)

Subject

Cancer Research,Oncology

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