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3. Observational database serenoa repens (DOSSER): Overview analysis and results - A multicentric SIUrO (Italian Society of Oncological Urology) Project

Author

Bertaccini, A., Giampaoli, M., Cividini, R., Gattoni, G. L., Sanseverino, R., Realfonso, T., Napodano, G., Fandella, A., Guidoni, E., Domenico PREZIOSO, Galasso, R., Cicalese, C., Scattoni, V., Armenio, A., Conti, G., Corinti, M., Spasciani, R., Liguori, G., Lampropoulou, N., Martorana, G., Bertaccini, Alessandro, Giampaoli, Marco, Cividini, Riccardo, Gattoni, Gian Luca, Sanseverino, Roberto, Realfonso, Tommaso, Napodano, Giorgio, Fandella, Andrea, Guidoni, Elisa, Prezioso, Domenico, Galasso, Raffaele, Cicalese, Carmine, Scattoni, Vincenzo, Armenio, Angelo, Conti, Giario, Corinti, Matteo, Spasciani, Roberta, Liguori, Giovanni, Lampropoulou, Nikolitsa, and Martorana, Giuseppe

Subjects
Serenoa repen, Inflammation, Male, Databases, Factual, Plant Extracts, LUTS, Urology, Prostate, Lower Urinary Tract Symptom, Prostatic Hyperplasia, Middle Aged, urologic and male genital diseases, Plant Extract, BPH, Phytotherapy, Serenoa repens, Lower Urinary Tract Symptoms, Retrospective Studie, Serenoa, Fruit, Humans, Retrospective Studies, Human
Abstract

Objective: Men affected with Benign Prostate Hyperplasia (BPH) and Lower Urinary Tract Symptoms (LUTS) are demonstrating to require an increasing amount of attention from Urologists and Primary-care Physicians. Over the years, common urological medications were based on either α-blockers and/or 5α-reductase inhibitors.During the last decade the phytotherapeutic drugs are gaining a more often central role in the BPH and LUTS managements. In particular, clinical usage of the extract of the dried ripe fruit of serenoa repens with a dosage of 320 mg per day, has shown its clinical efficacy and its superiority. Purpose of this multicentric observational retrospective study was to evaluate all the urological aspects (clinical, biochemical, instrumental and pathological) of patients affected by BPH and LUTS, with a PSA < 10 ng/ml, a previous negative prostatic biopsy and in therapy with a daily dose of 320/640 mg of serenoa repens. Patients and Methods: The study was conducted in 8 different centers throughout Italy from September 2010 to November 2011. Data and information of 298 men with an average of 63 years (mean PSA of 5.4 ng/ml and mean prostate gland volume of 57 cc), affected by non-acute urinary symptoms caused by BPH, a dosed PSA level inferior to 10 ng/ml, a previous negative prostate biopsy and in therapy with serenoa repens alone or associated to an α-blocker, were retrospectively inserted in an extensive on-line SIUrO Database. Comprehensive questionnaires were filled in for each patient at 3 and 6 months of follow-up. Each questionnaire contained various sections, each of them composed by several items: dosed PSA levels, uroflowmetry, International Prostate Symptoms Score (IPSS), International Index of Erectile Function (IIEF-5), trans-rectal ultrasound (TRUS) patterns, digital rectal examinations (DRE) aspects, previous prostate bioptical results (histology) and side effects. Results: PSA levels weren’t subjected to an increase, revealing a stabilizing or downward trend. Percentage of patients with PSA below the level of 4 ng/mL was lower at the end of the study. The overall changes in the uroflowmetry were similar and parallel both in the group with only serenoa repens intake and in the group with serenoa repens plus α-blocker. The mean medium flow and the mean maximum flow had a slightly increase along the observation time. There was a substantial decreasing in the amount of patients presenting severe prostatic symptoms. Patients reported through the IIEF-5 score a sexual activity substantially unchanged after 6 months of follow-up. The serenoa repens intake resulted in an improvement of the “inflammatory-like reports”, in terms of ultrasound patterns, DRE and bioptical features. Conclusions: serenoa repens demonstrated its efficacy reducing dysuria with minimal side effects. Further prospective studies might confirm its stabilization or lowering role on PSA levels in this cohort of patients and its possible clinical anti-inflammatory action.

4. Pros-IT CNR: an Italian prostate cancer monitoring project

Author

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

Subjects
Italian UCLA Cancer Index, Prostate cancer, Prostate cancer treatments, Quality of life, SF-12 Scale, Adult, Aged, Biopsy, Disease Management, Health Status, Humans, Italy, Male, Middle Aged, Neoplasm Staging, Prospective Studies, Prostatic Neoplasms, Quality of Life, Aging, Geriatrics and Gerontology, medicine.medical_specialty, 03 medical and health sciences, 0302 clinical medicine, medicine, 030212 general & internal medicine, Risk factor, Disease management (health), Prospective cohort study, Settore MED/36 - DIAGNOSTICA PER IMMAGINI E RADIOTERAPIA, Cancer staging, business.industry, medicine.disease, Clinical trial, Prostate cancer, Monitoring, Survival, Outcomes, Settore MED/24, Prostate cancer treatment, 030220 oncology & carcinogenesis, Family medicine, Physical therapy, Observational study, business
Abstract

Aims: The Pros-IT CNR project aims to monitor a sample of Italian males ≥18years 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 12months after the initial diagnosis. The 4th, 5th, 6th and 7th assessments, similar to the third, will be completed 24, 36, 48 and 60months 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.

Published
2017
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