ASCO GU 2026: ARTO Trial (NCT03449719): Long-Term Overall Survival Analysis from a Randomized Phase II Trial Testing the Benefit of Stereotactic Body Radiotherapy Addition to Abiraterone Acetate in Oligometastatic CRPC Patients

(UroToday.com) At ASCO GU 2026, Dr. Giulio Francolini presented the long-term overall survival (OS) and prostate cancer–specific survival (PCSS) results from the ARTO trial (NCT03449719), a randomized phase II study evaluating the addition of stereotactic body radiotherapy (SBRT) to abiraterone acetate in first-line oligometastatic castration-resistant prostate cancer (omCRPC).

ARTO is a randomized phase II trial testing the benefit of SBRT addition to abiraterone acetate in first-line oligometastatic CRPC (omCRPC). The trial was previously positive for biochemical and radiological progression-free survival (PFS).1 The current report presents an updated and comprehensive evaluation of OS and PCSS.

A total of 157 patients with omCRPC were randomized 1:1 to receive abiraterone acetate ± SBRT delivered to all sites of disease. No previous treatment for mCRPC was allowed.

Cox regression analysis was performed to compare:

  • Biochemical progression-free survival (bPFS)
  • Radiological progression-free survival (rPFS)
  • OS
  • PCSS

At a median follow-up of 53 months (IQR 43–60), previously reported benefits in bPFS and rPFS were confirmed in favor of the experimental arm:

  • bPFS: HR 0.49 (95% CI 0.33–0.73), p<0.001
  • rPFS: HR 0.48 (95% CI 0.32–0.72), p<0.001

Importantly, significant survival benefits were also observed:

  • OS: HR 0.55 (95% CI 0.33–0.92)
  • PCSS: HR 0.37 (95% CI 0.18–0.78)

These hazard ratios indicate a 45% relative reduction in risk of death overall and a 63% relative reduction in prostate cancer–specific mortality with the addition of SBRT.

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Figure 1. Overall Survival

 

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Figure 2. Prostate Cancer-specific Survival

 

Dr. Francolini concluded as follows:

  • Significant OS and PCSS benefit was detected in patients undergoing concomitant SBRT + abiraterone. These results warrant confirmation in phase III trials.
  • The ARTO trial provides some of the strongest long-term randomized evidence supporting metastasis-directed radiotherapy in the oligometastatic CRPC setting

Presented by: Giulio Francolini, MD, Radiation Oncologist, Radiation Oncology Unit, Azienda Ospedaliero Universitaria Careggi, Florence, Italy

Written by: Rashid K. Sayyid, MD, MSc, Assistant Professor, Urologic Oncologist, Department of Urology at The University of Arizona and Banner University Medical Center, Tucson, AZ – @rksayyid on X during the 2026 American Society of Clinical Oncology Genitourinary (ASCO GU) cancers symposium held in San Francisco, CA, between February 26th and 28th, 2026. 

References:

  1. Francolini G, Allegra AG, Detti B, et al. Stereotactic Body Radiation Therapy and Abiraterone Acetate for Patients Affected by Oligometastatic Castrate-Resistant Prostate Cancer: A Randomized Phase II Trial (ARTO). J Clin Oncol. 2023; 41(36):5561-8.