Study protocol and preliminary results from a mono-centric cohort within a trial testing stereotactic body radiotherapy and abiraterone (ARTO-NCT03449719) Article Swipe
Giulio Francolini
,
Beatrice Detti
,
Vanessa Di Cataldo
,
Pietro Garlatti
,
Michele Aquilano
,
Andrea Gaetano Allegra
,
Sara Lucidi
,
Cecilia Cerbai
,
Lucia Pia Ciccone
,
Viola Salvestrini
,
G. Stocchi
,
B. Guerrieri
,
Luca Visani
,
Mauro Loi
,
Isacco Desideri
,
Monica Mangoni
,
Icro Meattini
,
Lorenzo Livi
·
YOU?
·
· 2022
· Open Access
·
· DOI: https://doi.org/10.1007/s11547-022-01511-7
YOU?
·
· 2022
· Open Access
·
· DOI: https://doi.org/10.1007/s11547-022-01511-7
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.
Related Topics
Concepts
Medicine
Abiraterone acetate
Prostate cancer
Cohort
Prednisone
Internal medicine
Abiraterone
Population
Randomized controlled trial
Adverse effect
Clinical trial
Oncology
Quality of life (healthcare)
Sarcoma
Cancer
Urology
Androgen deprivation therapy
Pathology
Nursing
Androgen receptor
Environmental health
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1007/s11547-022-01511-7
- https://link.springer.com/content/pdf/10.1007/s11547-022-01511-7.pdf
- OA Status
- hybrid
- Cited By
- 10
- References
- 28
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4283650292
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
-
https://openalex.org/W4283650292Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1007/s11547-022-01511-7Digital Object Identifier
- Title
-
Study protocol and preliminary results from a mono-centric cohort within a trial testing stereotactic body radiotherapy and abiraterone (ARTO-NCT03449719)Work title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2022Year of publication
- Publication date
-
2022-06-28Full publication date if available
- Authors
-
Giulio Francolini, Beatrice Detti, Vanessa Di Cataldo, Pietro Garlatti, Michele Aquilano, Andrea Gaetano Allegra, Sara Lucidi, Cecilia Cerbai, Lucia Pia Ciccone, Viola Salvestrini, G. Stocchi, B. Guerrieri, Luca Visani, Mauro Loi, Isacco Desideri, Monica Mangoni, Icro Meattini, Lorenzo LiviList of authors in order
- Landing page
-
https://doi.org/10.1007/s11547-022-01511-7Publisher landing page
- PDF URL
-
https://link.springer.com/content/pdf/10.1007/s11547-022-01511-7.pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
hybridOpen access status per OpenAlex
- OA URL
-
https://link.springer.com/content/pdf/10.1007/s11547-022-01511-7.pdfDirect OA link when available
- Concepts
-
Medicine, Abiraterone acetate, Prostate cancer, Cohort, Prednisone, Internal medicine, Abiraterone, Population, Randomized controlled trial, Adverse effect, Clinical trial, Oncology, Quality of life (healthcare), Sarcoma, Cancer, Urology, Androgen deprivation therapy, Pathology, Nursing, Androgen receptor, Environmental healthTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
10Total citation count in OpenAlex
- Citations by year (recent)
-
2025: 3, 2024: 1, 2023: 6Per-year citation counts (last 5 years)
- References (count)
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28Number of works referenced by this work
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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