ARTO trial: Overall survival analysis from a randomized phase II trial testing the benefit of adding stereotactic body radiotherapy to abiraterone acetate in patients with oligometastatic castrate-resistant prostate cancer.

Authors

null

Giulio Francolini

Radiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of Florence, Florence, Italy

Giulio Francolini , Vanessa Di Cataldo , Pietro Garlatti , Beatrice Detti , Saverio Caini , Alessio Bruni , Gianluca Ingrosso , Rolando Maria D'Angelillo , Anna Rita Alitto , Matteo Augugliaro , Luca Triggiani , Silvana Parisi , Gaetano Facchini , Marco Banini , Gabriele Simontacchi , Isacco Desideri , Icro Meattini , Richard K. Valicenti , Lorenzo Livi

Organizations

Radiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of Florence, Florence, Italy, Department of Biomedical, Experimental and Clinical Sciences "Mario Serio", University of Florence, Florence, Italy, Institute for Cancer Research, Prevention and Clinical Network (ISPRO), Firenze, Italy, Radiation Oncology Unit, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy, Radiation Oncology Section, Department of Medicine and Surgery, University of Perugia, Perugia, Italy, Radiation Oncology, Department of Biomedicine and Prevention University of Rome "Tor Vergata", Roma, Italy, UOC di Radioterapia Oncologica, Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy, Unit of Radiotherapy, Azienda USL - IRCCS di Reggio Emilia, Reggio Emilia, Italy, Università degli Studi di Brescia, Department of Radiation Oncology, Brescia University, Brescia, Italy, Radiation Oncology Unit - Department of Biomedical, Dental Science and Morphological and Functional Images, University of Messina, Messina, Italy, Medical Oncology Unit, SM delle Grazie Hospital, Pozzuoli, Italy, University of California, Davis Comprehensive Cancer Center, Sacramento, CA

Research Funding

No funding sources reported

Background: ARTO (NCT03449719) is a multicentre, randomized phase II trial testing the benefit of stereotactic body radiation therapy (SBRT) addition to abiraterone acetate (AA) in oligometastatic Castrate Resistant Prostate Cancer (CRPC) patients. Trial ended in October 2022. Results already showed significant benefit in terms of biochemical response and Progression Free Survival (PFS) in the experimental arm, the trial was positive for its primary endpoint. Here we present an updated overall survival (OS) analysis. Methods: Patients affected by oligometastatic CRPC (< 3 non-visceral metastatic lesions) were enrolled in the trial and randomized 1:1 to receive either AA alone (control arm) or associated with concomitant SBRT on all sites of disease (treatment arm). Kaplan-Meier survival analysis was performed to compare OS in the different arms of treatment. Results: One hundred fifty-seven patients were enrolled in ARTO trial. After a median follow up of 27 months, 29 patients died (9 vs 20 in the experimental vs control arm, respectively). Median OS was not reached in neither of the two arms of treatment, with a non-significant trend in favour of the experimental arm (p=0.07). Conclusions: After an updated follow up analysis, results confirmed good prognosis for this population of oligo-metastatic CRPC patients. First line abiraterone acetate conferred long term OS in a selected cohort of patients affected by oligometastatic disease. A positive, nonsignificant trend was found in favour of experimental arm. Considering the low number of events detected, longer follow up is needed to explore impact of upfront SBRT on OS within this randomized phase II trial. Clinical trial information: NCT03449719.

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Abstract Details

Meeting

2024 ASCO Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Prostate Cancer

Track

Prostate Cancer - Advanced,Prostate Cancer - Localized

Sub Track

Therapeutics

Clinical Trial Registration Number

NCT03449719

Citation

J Clin Oncol 42, 2024 (suppl 4; abstr 132)

DOI

10.1200/JCO.2024.42.4_suppl.132

Abstract #

132

Poster Bd #

F3

Abstract Disclosures