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Impact of stereotactic body radiotherapy after progression in castrate resistant prostate cancer patients undergoing first line abiraterone treatment. A subgroup analysis from ARTO trial (NCT03449719)

Abstract

Background

ARTO trial was a phase II randomized trial suggesting the benefit of a concomitant treatment strategy including Abiraterone acetate plus predisone (AAP) and stereotactic body radiotherapy (SBRT) in oligometastatic castrate resistant prostate cancer (omCRPC). The object of the current analysis is to explore whether the benefit provided by SBRT to AAP is maintained at later stages of disease after oligoprogression

Methods

Patients enrolled in ARTO trial in whom a first progression event was reported were divided in two groups according to the treatment approach received, regardless of the initial randomization. After first progression event, Patients in Group A received SBRT on oligoprogressive disease, while patients in group B received second line systemic treatment. Palliative RT was not considered for the purpose of this analysis. Progression-Free survival (PFS) 1 and 2 were defined as time between AAP start and first progression event and time between first and second progression event, death or last follow up, (whichever came first), respectively. Cox regression analysis was performed to compare PFS1 + PFS2 in patients in group A vs Group B. Kaplan–Meier analysis was performed to compare overall survival between the two groups

Results

Median PFS1 + PFS2 was 45.9 months vs. not reached in group A (n = 43) vs Group B (n = 20), respectively (HR 0.63, 95% CI 0.17–2.33, p value 0.489), no significant difference was detected. Median OS was not reached in neither of the two arms of treatment, with a non-significant trend in favour of the experimental arm (HR 0.50, 95% CI 0.14–1.78, p = 0.284)

Conclusions

Results from the present analysis show that SBRT after progression may be a viable and feasible option for omCRPC after progression if compared to second line systemic therapy

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Fig. 1
Fig. 2
Fig. 3
Fig. 4: Swimmer plot summarizing different progression events for each patient.

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Data availability

The data that support the findings of this study are available from the corresponding author, GF, upon reasonable request.

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Acknowledgements

ARTO trial was conducted with a partial unconditional support grant by Janssen Cilag SpA. The authors thank the Fondazione Radioterapia Oncologica (FRO), individuals, and other organizations that have provided support for this scientific research. More specifically, the authors would like to deeply thank Conad, Fondazione Cassa di Risparmio di Pistoia e Pescia, Fabiani, Rinascente, Giorgio Tesi Group, IFCA, Permira.

Funding

The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.

Author information

Authors and Affiliations

Authors

Contributions

GF, NB, VdC, PG, MA, SC contributed to the study conception and design, AB, GI, RmD, LT, MAu, LTr, SP, GT,FA,GM, BAjF,AL,CF, FAl contributed to the material preparation, data collection and analysis, GS, DG, PBo, ML, GFr, LB, ID, IM, RV, LL contributed to the draft of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Giulio Francolini.

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Competing interests

The authors decalare no competing interests.

Ethics approval and consent to participate

This study was performed in accordance with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Area Vasta Centro (approval no. 12855_spe, October 9, 2018). Informed consent was obtained from all individual participants included in the study. Every human participant provided an informed consent.

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Francolini, G., Bertini, N., Di Cataldo, V. et al. Impact of stereotactic body radiotherapy after progression in castrate resistant prostate cancer patients undergoing first line abiraterone treatment. A subgroup analysis from ARTO trial (NCT03449719). Prostate Cancer Prostatic Dis 28, 908–912 (2025). https://doi.org/10.1038/s41391-025-00950-3

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