Early results from a phase II randomized trial testing stereotactic body radiation therapy in patients with oligometastatic castration resistant prostate cancer undergoing I line treatment with abiraterone acetate (ARTO trial-NCT03449719)

Garlatti, Pietro; Detti, Beatrice; Bruni, Antonio; Mantini, Giovanna; Pergolizzi, Stefano; Borghetti, Paolo; D’Angelillo, Rolando Maria; Alongi, Filippo; Jereczek-Fossa, B.A.; Franzese, Ciro; Tagliagambe, A.; Cataldo, V. Di; Aquilano, M.; Mariotti, Matteo; Salvestrini, Viola; Ciccone, L.P.; Stocchi, G.; Livi, Lorenzo

doi:10.1016/s2666-1683(20)36207-8

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“…No adverse events occurred in both arms of treatment. Preliminary results of this cohort were presented at European Multidisciplinary Congress on Urological Cancers (EMUC) in 2020 [ 14 ].…”

Section: Resultsmentioning

confidence: 99%

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

et al. 2022

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Background 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. Objective To present a preliminary overview about population features, clinical outcomes, adverse events, quality of life and explorative translational research. Design, setting, and participants 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. Outcome measurements and statistical analysis 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. Results and limitation 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%. Conclusions 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.

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“…No adverse events occurred in both arms of treatment. Preliminary results of this cohort were presented at European Multidisciplinary Congress on Urological Cancers (EMUC) in 2020 [ 14 ].…”

Section: Resultsmentioning

confidence: 99%