Evidence map›Paper›PMID 32725443›Full record

Trial reportMedical oncology (Northwood, London, England)2020

Phase II prospective trial "Give Me Five" short-term high precision radiotherapy for early prostate cancer with simultaneous boost to the dominant intraprostatic lesion: the impact of toxicity on quality of life (AIRC IG-13218).

Giulia Marvaso, Simone Giovanni Gugliandolo, Federica Bellerba, Sara Gandini, Giulia Corrao, Stefania Volpe, Damaris Patricia Rojas, Giulia Riva, Dario Zerini, Matteo Pepa and 11 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Medical oncology (Northwood, London, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01913717 (Short-term High Precision Radiotherapy for Early Prostate Cancer With Concomitant Boost on the Dominant Lesion), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.8field-weighted citation impact, top 24% 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.

NCT01913717 naunknown statusnot on this map

Short-term High Precision Radiotherapy for Early Prostate Cancer With Concomitant Boost on the Dominant Lesion

TypeinterventionalSponsorEuropean Institute of OncologyRan2014 to 2023Enrolled65ConditionsAdenocarcinoma of ProstateArmsExternal beam radiotherapy
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 11 citations in OpenAlex.

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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

21 authors at 5 institutions in 1 country.

Giulia MarvasoDivision of Radiotherapy, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy. giulia.marvaso@ieo.it.ORCID http://orcid.org/0000-0002-5339-8038
Simone Giovanni GugliandoloDepartment of Mechanical Engineering, Politecnico di Milano, Via La Masa 1, 20156, Milan, Italy.
Federica BellerbaMolecular and Pharmaco-Epidemiology Unit, Department of Experimental Oncology, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.
Sara GandiniMolecular and Pharmaco-Epidemiology Unit, Department of Experimental Oncology, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.
Giulia CorraoDivision of Radiotherapy, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.
Stefania VolpeDivision of Radiotherapy, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.
Damaris Patricia RojasDivision of Radiotherapy, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.
Giulia RivaClinical Department, National Center for Oncological Hadrontherapy (CNAO), Pavia, Italy.
Dario ZeriniDivision of Radiotherapy, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.
Matteo PepaDivision of Radiotherapy, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.
Cristiana Iuliana FodorDivision of Radiotherapy, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.
Eliana La RoccaDivision of Radiotherapy, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.
Paola PricoloDivision of Radiology, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.
Sarah AlessiDivision of Radiology, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.
Giuseppe PetraliaDepartment of Oncology and Hemato-Oncology, University of Milan, Via Festa del Perdono 7, 20122, Milan, Italy.
Francesco Alessandro MistrettaDepartment of Oncology and Hemato-Oncology, University of Milan, Via Festa del Perdono 7, 20122, Milan, Italy.
Raffaella CambriaMedical Physics Unit, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.
Federica CattaniMedical Physics Unit, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.
Ottavio De CobelliDepartment of Oncology and Hemato-Oncology, University of Milan, Via Festa del Perdono 7, 20122, Milan, Italy.
Roberto OrecchiaScientific Directorate, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.
Barbara Alicja Jereczek-FossaDivision of Radiotherapy, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.
Ripamonti · ITUniversity of Milan · ITIstituti di Ricovero e Cura a Carattere Scientifico · ITNational Center for Oncological Hadrontherapy · ITPolitecnico di Milano · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

As part of the AIRC IG-13218 (NCT01913717), we analyzed data from patients with low- and intermediate-risk prostate cancer treated with extreme hypofractionated radiotherapy (RT) and simultaneous boost to the intraprostatic lesion. The aim of the study is to identify clinically meaningful information through the analysis of validated questionnaires testing gastrointestinal (GI) and genitourinary (GU) RT-related toxicity and their impact on quality of life (QoL). At the end of RT treatment, clinical assessment and prostate-specific antigen (PSA) measurements were performed every 3 months for at least 2 years and GI and GU toxicities were evaluated contextually. QoL of enrolled patients was assessed by International Prostate Symptoms score (IPSS), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), EORTC QLQ prostate specific (QLQ-PR25), and sexual activity by International Index of Erectile Function (IIEF-5). Patients' score changes were calculated at the end of RT, at one month after RT and at 12 and 24 months. Sixty-five prospectively enrolled patients were analyzed. Extensive analysis of different QoL assessments showed that patients' tolerance was satisfactory across all the considered time points, with no statistically significant change of QoL from baseline compared to that before RT. Overall survival and biochemical progression-free survival at 2-years were of 98% and 97%, respectively. Despite the toxicity of extreme hypofractionation was low and tumor control was encouraging, a longer follow-up is necessary to confirm our findings. The increasing dose to the dominant intraprostatic lesion does not worsen the RT toxicity and consequently does not affect patients' QoL, thus questioning the possibility of an even more escalated treatment.

Indexed as

AgedHumansMaleNeoplasm GradingProspective StudiesProstatic NeoplasmsQuality of LifeRadiation Dose HypofractionationRadiation InjuriesRadiotherapy Planning, Computer-AssistedSurveys and QuestionnairesSurvival RateClinical trialDominant intraprostatic lesionExtreme hypofractionationProstate cancerQuality of life

Identifiers

PMID32725443
OpenAlexW3045913926

What OpenQuestion holds

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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.