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Pros-IT CNR: an Italian prostate cancer monitoring project

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Abstract

Aims

The Pros-IT CNR project aims to monitor a sample of Italian males ≥18 years of age who have been diagnosed in the participating centers with incident prostate cancer, by analyzing their clinical features, treatment protocols and outcome results in relation to quality of life.

Methods

Pros-IT CNR is an observational, prospective, multicenter study. The National Research Council (CNR), Neuroscience Institute, Aging Branch (Padua) is the promoting center. Ninety-seven Italian centers located throughout Italy were involved. The field study began in September 1, 2014. Subjects eligible were diagnosed with biopsy-verified prostate cancer, naïve. A sample size of 1500 patients was contemplated. A baseline assessment including anamnestic data, clinical history, risk factors, the initial diagnosis, cancer staging information and quality of life (Italian UCLA Prostate Cancer Index; SF-12 Scale) was completed. Six months after the initial diagnosis, a second assessment evaluating the patient’s health status, the treatment carried out, and the quality of life will be made. A third assessment, evaluating the treatment follow-up and the quality of life, will be made 12 months after the initial diagnosis. The 4th, 5th, 6th and 7th assessments, similar to the third, will be completed 24, 36, 48 and 60 months after the initial diagnosis, respectively, and will include also a Food Frequency Questionnaire and the Physical Activity Scale for the Elderly.

Discussion

The study will provide information on patients’ quality of life and its variations over time in relation to the treatments received for the prostate cancer.

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Abbreviations

ANOVA:

Analysis of variance

DCF:

Data collection form

LRP:

Laparoscopic radical prostatectomy

RALP:

Robot-assisted laparoscopic radical prostatectomy

SD:

Standard deviations

UCLA-PCI Index:

University of California Los Angeles-Prostate Cancer Index

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Acknowledgements

Pros-IT CNR is a non-profit observational study. Takeda Italia S.p.A. will furnish CNR with an unconditional grant to cover the cost of developing a web platform for data entry and the travel expenses of the Steering Committee, the Working Group and the Scientific Committee.

The Pros-IT CNR Group

Steering committee: Gaetano Crepaldi (Padova); Stefania Maggi (Padova); Marianna Noale (Padova); Angelo Porreca (Padova); Walter Artibani (Verona); Pierfrancesco Bassi (Roma); Sergio Bracarda (Arezzo); Giario Natale Conti (Como); Renzo Corvò (Genova); Pierpaolo Graziotti (Milano); Riccardo Maurizi Enrici (Roma); Vincenzo Mirone (Napoli); Rodolfo Montironi (Ancona).

Scientific committee: Filippo Bertoni (Brescia); Mauro Gacci (Firenze); Stefano Maria Magrini (Brescia); Giovanni Muto (Roma); Stefano Pecoraro (Avellino); Umberto Ricardi (Torino); Andrea Tubaro (Roma); Vittorina Zagonel (Padova); Filiberto Zattoni (Padova).

Working Group: Anna Rita Alitto (Roma); Enrica Ambrosi (Brescia); Alessandro Antonelli (Brescia); Cynthia Aristei (Perugia); Michele Barbieri (Napoli); Franco Bardari (Asti); Lilia Bardoscia (Brescia); Salvina Barra (Genova); Sara Bartoncini (Torino); Umberto Basso (Padova); Carlotta Becherini (Firenze); Rita Bellavita (Perugia); Franco Bergamaschi (Reggio Emilia); Stefania Berlingheri (Brescia); Alfredo Berruti (Brescia); Marco Borghesi (Bologna); Roberto Bortolus (Pordenone); Valentina Borzillo (Napoli); Davide Bosetti (Milano); Giuseppe Bove (Foggia); Pierluigi Bove (Roma); Maurizio Brausi (Modena); Alessio Bruni (Modena); Giorgio Bruno (Ravenna); Eugenio Brunocilla (Bologna); Alberto Buffoli (Brescia); Michela Buglione (Brescia); Consuelo Buttigliero (Torino); Giovanni Cacciamani (Verona); Michela Caldiroli (Varese); Giuseppe Cardo (Bari); Giorgio Carmignani (Genova); Giuseppe Carrieri (Foggia); Emanuele Castelli (Torino); Elisabetta Castrezzati (Brescia); Gianpiero Catalano (Milano); Susanna Cattarino (Roma); Francesco Catucci (Roma); Dario Cavallini Francolini (Pavia); Ofelia Ceccarini (Bergamo); Antonio Celia (Vicenza); Francesco Chiancone (Napoli); Tommaso Chini (Firenze); Claudia Cianci (Pisa); Antonio Cisternino (Foggia); Devis Collura (Torino); Franco Corbella (Pavia); Matteo Corinti (Como); Paolo Corsi (Verona); Fiorenza Cortese (Alessandria); Luigi Corti (Padova); Cosimo De Nunzio (Roma); Olga Cristiano (Avellino); Rolando D’Angelillo (Roma); Luigi Da Pozzo (Bergamo); Daniele D’agostino (Padova); David D’Andrea (Bolzano); Matteo Dandrea (Padova); Michele De Angelis (Arezzo); Ottavio De Cobelli (Milano); Bernardino De Concilio (Vicenza); Antonello De Lisa (Cagliari); Stefano De Luca (Torino); Agostina De Stefani (Bergamo); Chiara Lucrezia Deantoni (Milano); Claudio Degli Esposti (Bologna); Anna Destito (Catanzaro); Beatrice Detti (Firenze); Nadia Di Muzio (Milano); Andrea Di Stasio (Alessandria); Calogero Di Stefano (Ravenna); Danilo Di Trapani (Palermo); Giuseppe Difino (Foggia); Sara Falivene (Napoli); Giuseppe Farullo (Roma); Paolo Fedelini (Napoli); Ilaria Ferrari (Varese); Francesco Ferrau (Messina); Matteo Ferro (Milano); Andrei Fodor (Milano); Francesco Fontana (Novara); Francesco Francesca (Pisa); Giulio Francolini (Firenze); Paolo Frata (Brescia); Giovanni Frezza (Bologna); Pietro Gabriele (Torino); Maria Galeandro (Reggio Emilia); Elisabetta Garibaldi (Torino); Pietro Giovanni Gennari (Arezzo); Alessandro Gentilucci (Roma); Alessandro Giacobbe (Torino); Laura Giussani (Varese); Giuseppe Giusti (Cagliari); Paolo Gontero (Torino); Alessia Guarneri (Torino); Cesare Guida (Avellino); Alberto Gurioli (Torino); Dorijan Huqi (Bolzano); Ciro Imbimbo (Napoli); Gianluca Ingrosso (Roma); Cinzia Iotti (Reggio Emilia); Corrado Italia (Bergamo); Pierdaniele La Mattina (Milano); Enza Lamanna (Ravenna); Luciana Lastrucci (Arezzo); Grazia Lazzari (Taranto); Fabiola Liberale (Biella); Giovanni Liguori (Trieste); Roberto Lisi (Roma); Frank Lohr (Modena); Riccardo Lombardo (Roma); Jon Lovisolo (Varese); Giuseppe Mario Ludovico (Bari); Nicola Macchione (Novara); Francesca Maggio (Imperia); Michele Malizia (Bologna); Gianluca Manasse (Perugia); Giovanni Mandoliti (Rovigo); Giovanna Mantini (Roma); Luigi Marafioti (Cosenza); Luisa Marciello (Prato); Alberto Mario Marconi (Varese); Antonietta Martillotta (Cosenza); Salvino Marzano (Prato); Stefano Masciullo (Bergamo); Gloria Maso (Verbania); Adele Massenzo (Cosenza); Ercole Mazzeo (Modena); Luigi Mearini (Perugia); Serena Medoro (Ferrara); Rosa Molè (Catanzaro); Giorgio Monesi (Novara); Emanuele Montanari (Milano); Franco Montefiore (Alessandria); Giampaolo Montesi (Rovigo); Giuseppe Morgia (Catania); Gregorio Moro (Biella); Giorgio Muscas (Cagliari); Daniela Musio (Roma); Paolo Muto (Napoli); Giovanni Muzzonigro (Ancona); Giorgio Napodano (Salerno); Carlo Luigi Augusto Negro (Asti); Mattia Nidini (Mantova); Maria Ntreta (Bologna); Marco Orsatti (Imperia); Carmela Palazzolo (Messina); Isabella Palumbo (Perugia); Alessandro Parisi (Bologna); Paolo Parma (Mantova); Nicola Pavan (Trieste); Martina Pericolini (Roma); Francesco Pinto (Roma); Antonio Pistone (Salerno); Valerio Pizzuti (Grosseto); Angelo Platania (Messina); Caterina Polli (Prato); Giorgio Pomara (Pisa); Elisabetta Ponti (Roma); Antonio Benito Porcaro (Verona); Francesco Porpiglia (Torino); Dario Pugliese (Roma); Armin Pycha (Bolzano); Giuseppe Raguso (Reggio Emilia); Andrea Rampini (Arezzo); Donato Franco Randone (Torino); Valentina Roboldi (Bergamo); Marco Roscigno (Bergamo); Maria Paola Ruggieri (Reggio Emilia); Giuseppe Ruoppo (Reggio Emilia); Roberto Sanseverino (Salerno); Anna Santacaterina (Messina); Michele Santarsieri (Pisa); Riccardo Santoni (Roma); Sarah Scagliarini (Napoli); Giorgio Vittorio Scagliotti (Torino); Mauro Scanzi (Brescia); Marcello Scarcia (Bari); Riccardo Schiavina (Bologna); Alessandro Sciarra (Roma); Carmine Sciorio (Lecco); Tindaro Scolaro (La Spezia); Salvatore Scuzzarella (Lecco); Oscar Selvaggio (Foggia); Armando Serao (Alessandria); Sergio Serni (Firenze); Marco Andrea Signor (Udine); Mauro Silvani (Biella); Giovanni Silvano (Taranto); Franco Silvestris (Bari); Claudio Simeone (Brescia); Valeria Simone (Bari); Girolamo Spagnoletti (Foggia); Matteo Giulio Spinelli (Milano); Luigi Squillace (Pavia); Vincenzo Tombolini (Roma); Mariastella Toninelli (Brescia); Luca Triggiani (Brescia); Alberto Trinchieri (Lecco); Luca Eolo Trodella (Roma); Lucio Trodella (Roma); Carlo Trombetta (Trieste); Lidia Tronnolone (Roma); Marcello Tucci (Torino); Daniele Urzì (Catania); Riccardo Valdagni (Milano); Maurizio Valeriani (Roma); Maurizio Vanoli (La Spezia); Elisabetta Vitali (Bergamo); Stefano Zaramella (Novara); Guglielmo Zeccolini (Vicenza); Giampaolo Zini (Ferrara).

Author contributions

All authors participated in the study design; SM, GCr and MN drafted the protocol. All the authors critically reviewed the protocol, read and approved the final manuscript. The authors wish to thank Linda Inverso Moretti for reviewing the English version of this paper.

Author information

Author notes

    Authors and Affiliations

    1. CNR, Aging Branch, Neuroscience Institute, Via Giustiniani 2, 35128, Padova, Italy

      Marianna Noale, Stefania Maggi & Gaetano Crepaldi

    2. Azienda Ospedaliera Universitaria integrata di Verona, Verona, Italy

      Walter Artibani

    3. Policlinico Universitario A. Gemelli, Università Cattolica del Sacro Cuore di Milano-sede di Roma, Milan, Italy

      Pier Francesco Bassi

    4. Prostate Group of AIRO-Italian Association for Radiation Oncology, Brescia, Italy

      Filippo Bertoni

    5. Ospedale San Donato, Arezzo, Italy

      Sergio Bracarda

    6. Ospedale Sant’Anna, Como, Italy

      Giario Natale Conti

    7. IRCCS San Martino-IST, Genova, Italy

      Renzo Corvò

    8. Università di Firenze, Florence, Italy

      Mauro Gacci

    9. Ospedale S. Giuseppe, Milano, Italy

      Pierpaolo Graziotti

    10. Università di Brescia, Brescia, Italy

      Stefano Maria Magrini

    11. Università di Roma Sapienza, Roma, Italy

      Riccardo Maurizi Enrici

    12. Università degli Studi di Napoli Federico II, Napoli, Italy

      Vincenzo Mirone

    13. Università Politecnica delle Marche, Ancona, Italy

      Rodolfo Montironi

    14. Università Campus Bio-medico, Roma, Italy

      Giovanni Muto

    15. Malzoni Center, Avellino, Italy

      Stefano Pecoraro

    16. Policlinico di Abano Terme, Padova, Italy

      Angelo Porreca

    17. Università di Torino, Turin, Italy

      Umberto Ricardi

    18. Ospedale Sant’Andrea, Roma, Italy

      Andrea Tubaro

    19. Istituto Oncologico Veneto IOV-IRCCS, Padova, Italy

      Vittorina Zagonel

    20. Università di Padova, Padova, Italy

      Filiberto Zattoni

    Authors
    1. Marianna Noale
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    2. Stefania Maggi
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    11. Stefano Maria Magrini
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    22. Gaetano Crepaldi
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    Consortia

    the Pros-IT CNR study group

    • Gaetano Crepaldi
    • , Stefania Maggi
    • , Marianna Noale
    • , Angelo Porreca
    • , Walter Artibani
    • , Pier Francesco Bassi
    • , Sergio Bracarda
    • , Giario Natale Conti
    • , Renzo Corvò
    • , Pierpaolo Graziotti
    • , Riccardo Maurizi Enrici
    • , Vincenzo Mirone
    • , Rodolfo Montironi
    • , Filippo Bertoni
    • , Mauro Gacci
    • , Stefano Maria Magrini
    • , Giovanni Muto
    • , Stefano Pecoraro
    • , Umberto Ricardi
    • , Andrea Tubaro
    • , Vittorina Zagonel
    • , Filiberto Zattoni
    • , Anna Rita Alitto
    • , Enrica Ambrosi
    • , Alessandro Antonelli
    • , Cynthia Aristei
    • , Michele Barbieri
    • , Franco Bardari
    • , Lilia Bardoscia
    • , Salvina Barra
    • , Sara Bartoncini
    • , Umberto Basso
    • , Carlotta Becherini
    • , Rita Bellavita
    • , Franco Bergamaschi
    • , Stefania Berlingheri
    • , Alfredo Berruti
    • , Marco Borghesi
    • , Roberto Bortolus
    • , Valentina Borzillo
    • , Davide Bosetti
    • , Giuseppe Bove
    • , Pierluigi Bove
    • , Maurizio Brausi
    • , Alessio Bruni
    • , Giorgio Bruno
    • , Eugenio Brunocilla
    • , Alberto Buffoli
    • , Michela Buglione
    • , Consuelo Buttigliero
    • , Giovanni Cacciamani
    • , Michela Caldiroli
    • , Giuseppe Cardo
    • , Giorgio Carmignani
    • , Giuseppe Carrieri
    • , Emanuele Castelli
    • , Elisabetta Castrezzati
    • , Gianpiero Catalano
    • , Susanna Cattarino
    • , Francesco Catucci
    • , Dario Cavallini Francolini
    • , Ofelia Ceccarini
    • , Antonio Celia
    • , Francesco Chiancone
    • , Tommaso Chini
    • , Claudia Cianci
    • , Antonio Cisternino
    • , Devis Collura
    • , Franco Corbella
    • , Matteo Corinti
    • , Paolo Corsi
    • , Fiorenza Cortese
    • , Luigi Corti
    • , Cosimo de Nunzio
    • , Olga Cristiano
    • , Rolando D’Angelillo
    • , Luigi Da Pozzo
    • , Daniele D’agostino
    • , David D’Andrea
    • , Matteo Dandrea
    • , Michele De Angelis
    • , Ottavio De Cobelli
    • , Bernardino De Concilio
    • , Antonello De Lisa
    • , Stefano De Luca
    • , Agostina De Stefani
    • , Chiara Lucrezia Deantoni
    • , Claudio Degli Esposti
    • , Anna Destito
    • , Beatrice Detti
    • , Nadia Di Muzio
    • , Andrea Di Stasio
    • , Calogero Di Stefano
    • , Danilo Di Trapani
    • , Giuseppe Difino
    • , Sara Falivene
    • , Giuseppe Farullo
    • , Paolo Fedelini
    • , Ilaria Ferrari
    • , Francesco Ferrau
    • , Matteo Ferro
    • , Andrei Fodor
    • , Francesco Fontana
    • , Francesco Francesca
    • , Francolini Giulio
    • , Paolo Frata
    • , Giovanni Frezza
    • , Pietro Gabriele
    • , Maria Galeandro
    • , Elisabetta Garibaldi
    • , Pietro Gennari
    • , Alessandro Gentilucci
    • , Alessandro Giacobbe
    • , Laura Giussani
    • , Giuseppe Giusti
    • , Paolo Gontero
    • , Alessia Guarneri
    • , Cesare Guida
    • , Alberto Gurioli
    • , Dorijan Huqi
    • , Ciro Imbimbo
    • , Gianluca Ingrosso
    • , Cinzia Iotti
    • , Corrado Italia
    • , Pierdaniele La Mattina
    • , Enza Lamanna
    • , Luciana Lastrucci
    • , Grazia Lazzari
    • , Fabiola Liberale
    • , Giovanni Liguori
    • , Roberto Lisi
    • , Frank Lohr
    • , Riccardo Lombardo
    • , Jon Lovisolo
    • , Giuseppe Mario Ludovico
    • , Nicola Macchione
    • , Francesca Maggio
    • , Michele Malizia
    • , Gianluca Manasse
    • , Giovanni Mandoliti
    • , Giovanna Mantini
    • , Luigi Marafioti
    • , Luisa Marciello
    • , Alberto Mario Marconi
    • , Antonietta Martillotta
    • , Salvino Marzano
    • , Stefano Masciullo
    • , Gloria Maso
    • , Adele Massenzo
    • , Ercole Mazzeo
    • , Luigi Mearini
    • , Serena Medoro
    • , Rosa Molè
    • , Giorgio Monesi
    • , Emanuele Montanari
    • , Franco Montefiore
    • , Giampaolo Montesi
    • , Giuseppe Morgia
    • , Gregorio Moro
    • , Giorgio Muscas
    • , Daniela Musio
    • , Paolo Muto
    • , Giovanni Muzzonigro
    • , Giorgio Napodano
    • , Carlo Luigi Augusto Negro
    • , Mattia Nidini
    • , Maria Ntreta
    • , Marco Orsatti
    • , Carmela Palazzolo
    • , Isabella Palumbo
    • , Alessandro Parisi
    • , Paolo Parma
    • , Nicola Pavan
    • , Martina Pericolini
    • , Francesco Pinto
    • , Antonio Pistone
    • , Valerio Pizzuti
    • , Angelo Platania
    • , Caterina Polli
    • , Giorgio Pomara
    • , Elisabetta Ponti
    • , Antonio Benito Porcaro
    • , Francesco Porpiglia
    • , Dario Pugliese
    • , Armin Pycha
    • , Giuseppe Raguso
    • , Andrea Rampini
    • , Donato Franco Randone
    • , Marco Roscigno
    • , Maria Paola Ruggieri
    • , Giuseppe Ruoppo
    • , Roberto Sanseverino
    • , Anna Santacaterina
    • , Michele Santarsieri
    • , Riccardo Santoni
    • , Sarah Scagliarini
    • , Giorgio Vittorio Scagliotti
    • , Mauro Scanzi
    • , Marcello Scarcia
    • , Riccardo Schiavina
    • , Alessandro Sciarra
    • , Carmine Sciorio
    • , Tindaro Scolaro
    • , Salvatore Scuzzarella
    • , Oscar Selvaggio
    • , Armando Serao
    • , Sergio Serni
    • , Marco Andrea Signor
    • , Mauro Silvani
    • , Giovanni Silvano
    • , Franco Silvestris
    • , Claudio Simeone
    • , Valeria Simone
    • , Girolamo Spagnoletti
    • , Matteo Giulio Spinelli
    • , Luigi Squillace
    • , Vincenzo Tombolini
    • , Mariastella Toninelli
    • , Luca Triggiani
    • , Alberto Trinchieri
    • , Luca Eolo Trodella
    • , Lucio Trodella
    • , Carlo Trombetta
    • , Lidia Tronnolone
    • , Marcello Tucci
    • , Daniele Urzì
    • , Riccardo Valdagni
    • , Maurizio Valeriani
    • , Maurizio Vanoli
    • , Elisabetta Vitali
    • , Stefano Zaramella
    • , Guglielmo Zeccolini
    •  & Giampaolo Zini

    Corresponding author

    Correspondence to Marianna Noale.

    Ethics declarations

    Conflict of interest

    V. Mirone is a Consultant for Menarini, GSK, Lilly. S. Bracarda is an Advisory Board Member for Astellas, Bayer, Janssen, Genentech. The authors: M. Noale, S. Maggi, W. Artibani, P.F. Bassi, F. Bertoni, G.N. Conti, R. Corvò, M. Gacci, P. Graziotti, S.M. Magrini, R. Maurizi Enrici, R. Montironi, G. Muto, S. Pecoraro, A. Porreca, U. Ricardi, A. Tubaro, V. Zagonel, F. Zattoni and G. Crepaldi declare that they have no conflicts of interest and no competing interests.

    Ethical approval

    The study protocol was approved by the Ethic Committee of the Clinical Coordinating Center (Sant’Anna Hospital, Como; March 13, 2014, register number 45/2014). The protocol was also approved by the competent Ethic Committee of each participating center.

    Informed consent

    Informed consent was obtained from all individual participants included in the study.

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    M. Noale and S. Maggi equally contributed to the paper.

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    Noale, M., Maggi, S., Artibani, W. et al. Pros-IT CNR: an Italian prostate cancer monitoring project. Aging Clin Exp Res 29, 165–172 (2017). https://doi.org/10.1007/s40520-017-0735-6

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