Study protocol and preliminary results from a mono-centric cohort within a trial testing stereotactic body radiotherapy and abiraterone (ARTO-NCT03449719)
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Published:2022-06-28
Issue:8
Volume:127
Page:912-918
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ISSN:1826-6983
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Container-title:La radiologia medica
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language:en
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Short-container-title:Radiol med
Author:
Francolini Giulio, Detti BeatriceORCID, Di Cataldo Vanessa, Garlatti Pietro, Aquilano Michele, Allegra Andrea, Lucidi Sara, Cerbai Cecilia, Ciccone Lucia Pia, Salvestrini Viola, Stocchi Giulia, Guerrieri Barbara, Visani Luca, Loi Mauro, Desideri Isacco, Mangoni Monica, Meattini Icro, Livi Lorenzo
Abstract
Abstract
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.
Funder
Università degli Studi di Firenze
Publisher
Springer Science and Business Media LLC
Subject
Radiology, Nuclear Medicine and imaging,General Medicine
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