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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)

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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.

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Abbreviations

AIRC:

Associazione Italiana per la Ricerca sul Cancro

b-PFS:

Biochemical progression-free survival

CT:

Computed tomography

CTV:

Clinical target volume

DIL:

Dominant intraprostatic lesion

EORTC:

European Organization for Research and Treatment of Cancer

G:

Grade

GEE:

Generalized estimation method

GI:

Gastrointestinal

GU:

Genitourinary

IEO:

European Institute of Oncology IRCCS

IGRT:

Image-guided radiation therapy

IIEF-5:

International index of erectile function

IMRT:

Intensity-modulated radiotherapy

IPSS:

International prostatic symptoms score

IQR:

Interquartile range

MAR:

Missing at random

mpMRI:

Multiparametric resonance imaging

NCCN:

National comprehensive cancer network

OAR:

Organ at risk

OS:

Overall survival

PCa:

Prostate cancer

PET:

Positron emission tomography

PRO:

Patient-reported outcome

PSA:

Prostate-specific antigen

PTV:

Planning target volume

QLQ-C30:

Quality life questionnaire-core 30

QLQ-PR25:

Quality life questionnaire prostate specific

QoL:

Quality of life

RT:

Radiotherapy

RTOG:

Radiation Therapy Oncology Group

SBRT:

Stereotactic body radiotherapy

SIB:

Simultaneous integrated boost

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Acknowledgements

SGG was partially Supported by Associazione Italiana per la Ricerca sul Cancro (AIRC), by Project IG-14300 “Carbon ions boost followed by pelvic photon intensity-modulated radiotherapy for high-risk prostate cancer,” registered at ClinicalTrials.gov (NCT02672449). The study was also supported by Project IG-13218 “Short-term High Precision Radiotherapy for Early Prostate Cancer With Concomitant Boost on the Dominant Lesion,” registered at ClinicalTrials.gov (NCT01913717). The sponsors did not play any role in the study design, collection, analysis, and interpretation of data, nor in the writing of the manuscript, nor in the decision to submit the manuscript for publication.

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Author notes

  1. Giulia Marvaso and Simone Giovanni Gugliandolo have equally contributed.

Authors and Affiliations

  1. Division of Radiotherapy, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy

    Giulia Marvaso, Giulia Corrao, Stefania Volpe, Damaris Patricia Rojas, Dario Zerini, Matteo Pepa, Cristiana Iuliana Fodor, Eliana La Rocca & Barbara Alicja Jereczek-Fossa

  2. Department of Oncology and Hemato-Oncology, University of Milan, Via Festa del Perdono 7, 20122, Milan, Italy

    Giulia Marvaso, Giulia Corrao, Stefania Volpe, Eliana La Rocca, Giuseppe Petralia, Francesco Alessandro Mistretta, Ottavio De Cobelli & Barbara Alicja Jereczek-Fossa

  3. Department of Mechanical Engineering, Politecnico di Milano, Via La Masa 1, 20156, Milan, Italy

    Simone Giovanni Gugliandolo

  4. Department of Chemistry, Materials and Chemical Engineering “Giulio Natta”, Politecnico di Milano, Piazza Leonardo da Vinci 32, 20133, Milan, Italy

    Simone Giovanni Gugliandolo

  5. Molecular and Pharmaco-Epidemiology Unit, Department of Experimental Oncology, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy

    Federica Bellerba & Sara Gandini

  6. Clinical Department, National Center for Oncological Hadrontherapy (CNAO), Pavia, Italy

    Giulia Riva

  7. Division of Radiology, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy

    Paola Pricolo, Sarah Alessi & Giuseppe Petralia

  8. Division of Urology, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy

    Francesco Alessandro Mistretta & Ottavio De Cobelli

  9. Medical Physics Unit, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy

    Raffaella Cambria & Federica Cattani

  10. Scientific Directorate, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy

    Roberto Orecchia

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  1. Giulia Marvaso
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  2. Simone Giovanni Gugliandolo
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Contributions

GM and BAJF were responsible for the study conception and design and had final responsibility for the decision to submit the manuscript for publication. GM, SGG, FB, and SG drafted the manuscript. GM, GC, SV, DPR, GR, DZ, CIF, ELR, PP, SA, GP, FAM, RC, and FC were responsible for acquisition and analysis of data. GM, SGG, FB, SG, and BAJF were responsible for interpretation of data. MP, ODC, RO, and BAJF substantially revised the work. All authors have read and approved the final version of the manuscript and have agreed both to be personally accountable for the author’s own contributions and to ensure that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved, and the resolution documented in the literature.

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Correspondence to Giulia Marvaso.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. In this research, no animals were involved.

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All patients signed a written informed consent for radiation therapy and written informed consent for the use of the anonymized data for research or educational purpose. The present study has been reviewed and approved by the Internal Review Board of the Division of Radiotherapy, IEO, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.

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Marvaso, G., Gugliandolo, S.G., Bellerba, F. et al. 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). Med Oncol 37, 74 (2020). https://doi.org/10.1007/s12032-020-01397-3

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