Evidence map›Paper›PMID 35763249›Full record

Trial reportLa Radiologia medica2022

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

Giulio Francolini, Beatrice Detti, Vanessa Di Cataldo, Pietro Garlatti, Michele Aquilano, Andrea Allegra, Sara Lucidi, Cecilia Cerbai, Lucia Pia Ciccone, Viola Salvestrini and 8 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in La Radiologia medica, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03449719 (A 2 Arm, Phase II Controlled Randomized Trial Comparing Efficacy and Safety of Abiraterone and Abiraterone Associated With of Ablative Radiation Therapy in Patients With Oligometastatic Castration Resistant Prostate Cancer), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.5field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03449719 naunknown statusnot on this map

A 2 Arm, Phase II Controlled Randomized Trial Comparing Efficacy and Safety of Abiraterone and Abiraterone Associated With of Ablative Radiation Therapy in Patients With Oligometastatic Castration Resistant Prostate Cancer (ARTO Trial)

TypeinterventionalSponsorLorenzo LiviRan2018 to 2022Enrolled174ConditionsRate of PSA Response in Oligometastatic,CRPC Undergoing SBRT in Combination With Abiraterone Acetate (AA), Compared to Patients Treated With AA AloneArmsSBRT - Ablative radiation Therapy, Abiraterone Acetate
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Review
  6. Stereotactic reirradiation with CyberknifeLa Radiologia medica · 2023
    Article
  7. Article
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 2 institutions in 1 country.

Giulio FrancoliniRadiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of Florence, Largo Brambilla 3, 50139, Florence, Italy.
Beatrice DettiRadiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of Florence, Largo Brambilla 3, 50139, Florence, Italy. beatrice.detti@aouc.unifi.it.ORCID http://orcid.org/0000-0001-5799-5924
Vanessa Di CataldoRadiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of Florence, Largo Brambilla 3, 50139, Florence, Italy.
Pietro GarlattiRadiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of Florence, Largo Brambilla 3, 50139, Florence, Italy.
Michele AquilanoDepartment of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy.
Andrea AllegraDepartment of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy.
Sara LucidiDepartment of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy.
Cecilia CerbaiDepartment of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy.
Lucia Pia CicconeDepartment of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy.
Viola SalvestriniDepartment of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy.
Giulia StocchiDepartment of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy.
Barbara GuerrieriDepartment of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy.
Luca VisaniCyberKnife Center, Istituto Fiorentino di Cura ed Assistenza, Florence, Italy.
Mauro LoiRadiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of Florence, Largo Brambilla 3, 50139, Florence, Italy.
Isacco DesideriDepartment of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy.
Monica MangoniDepartment of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy.
Icro MeattiniDepartment of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy.
Lorenzo LiviDepartment of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy.
University of Florence · ITAzienda Ospedaliero-Universitaria Careggi · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundARTO 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.

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

participantsARTO (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%.

conclusionsSBRT + 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.

Indexed as

AndrostenesChemoradiotherapyProstatic Neoplasms, Castration-ResistantRadiosurgeryAbiraterone AcetateClinical Trial Protocols as TopicCohort StudiesHumansMaleProstate-Specific AntigenQuality of LifeTreatment OutcomeabirateroneAbiraterone AcetateAndrostenesProstate-Specific AntigenAbirateronemCRPCOligometastatisProtocolSBRT

Identifiers

PMID35763249
PMCPMC9349091
OpenAlexW4283650292

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.