Study protocol and preliminary results from a mono-centric cohort within a trial testing stereotactic body radiotherapy and abiraterone (ARTO-NCT03449719).

ARTO trial was designed to evaluate the difference in terms of outcomes between patients affected by oligo metastatic castrate resistant prostate cancer (mCRPC) treated with Abiraterone acetate and randomized to receive or not SBRT on all sites of disease. Here, we present a preliminary analysis conducted on patients enrolled at promoting institution.

To present a preliminary overview about population features, clinical outcomes, adverse events, quality of life and explorative translational research.

ARTO (NCT03449719) is a phase II trial including patients affected by oligo mCRPC, randomized to receive standard of care (GnRH agonist or antagonist plus abiraterone acetate 1000 mg and oral prednisone 10 mg daily) with or without SBRT on all metastatic sites of disease. All subjects have < 3 bone or nodal metastases. All patients are treated in I line mCRPC setting, no previous lines of treatment for mCRPC are allowed.

Data about a mono-centric cohort of 42 patients enrolled are presented in the current analysis, with focus on baseline population features, PSA drop at 3 months, biochemical response, and quality of life outcomes. Descriptive statistics regarding translational research are also presented.

Significant difference in terms of PSA drop at three months was not detected (p = 0.68). Biochemical response (PSA reduction > 50%) was reported in 73.7 versus 76.5% of patients in control vs SBRT arm, respectively (p = 0.84). All patients are alive. Progression occurred in 1 versus 0 patients in the control versus SBRT arm, respectively. After 3 months, an average decrease of 13 points in terms of Global Health Score was reported for the overall population. However, complete recovery was noticed at 6 months. Circulating tumor cells detection rate was 40%.

SBRT + Abiraterone treatment was safe and well tolerated, non-significant trend in terms of PSA drop and biochemical response at 3 months was detected in SBRT arm. Interestingly, CTCs detection in this selected cohort of oligo-mCRPC was lower if compared to historical data of unselected mCRPC patients.

La Radiologia medica. 2022 Jun 28 [Epub ahead of print]

Giulio Francolini, Beatrice Detti, Vanessa Di Cataldo, Pietro Garlatti, Michele Aquilano, Andrea Allegra, Sara Lucidi, Cecilia Cerbai, Lucia Pia Ciccone, Viola Salvestrini, Giulia Stocchi, Barbara Guerrieri, Luca Visani, Mauro Loi, Isacco Desideri, Monica Mangoni, Icro Meattini, Lorenzo Livi

Radiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of Florence, Largo Brambilla 3, 50139, Florence, Italy., Radiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of Florence, Largo Brambilla 3, 50139, Florence, Italy. ., Department of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy., CyberKnife Center, Istituto Fiorentino di Cura ed Assistenza, Florence, Italy.

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