Neoadjuvant Hormone Treatment with Leuprolide Acetate Depot 3.75 mg and Cyproterone Acetate, before Radical Prostatectomy: A Randomized StudyPrezioso D. · Lotti T. · Polito M. · Montironi R.
Urology Clinic, University ‘Federico II’, Naples, Italy
Objectives: To assess the effect of neoadjuvant hormone treatment before radical prostatectomy on: tumor/prostate volume, prostate-specific antigen (PSA) and testosterone levels, surgical margin status and tumor stage, and the ease of surgery following treatment. Methods: Patients with clinically localized prostatic carcinoma were randomized to receive leuprolide acetate depot 3.75 mg once a month for 3 months and cyproterone acetate 300 mg once a week for 3 weeks prior to surgery (group A). A control group of patients had surgery without any pretreatment (group B). Results: 167 patients were evaluated for the efficacy parameters. In group A, 31% of patients had a reduction in tumor/prostate volume following hormone therapy. PSA and testosterone levels were significantly reduced (p = 0.0001) in patients in group A compared to basal values. Centralized histopathological data evaluated in 145 patients (group A and 75 group B) showed that more patients in group B had tumors at stages T3A and T3B than in group A; this difference was close to significance (p = 0.057). Positive surgical margins were more common in group B (60% of patients) compared to group A (39% of patients). Similarly lymph node involvement was more common in group B compared to group A (11 versus 3%). There was little difference between the 2 study groups for the other surgical parameters assessed (ease of dissection, duration of surgery, blood loss). Conclusions: Neoadjuvant hormone therapy before radical prostatectomy has some effects in the treatment of prostate cancer. However, long-term follow-up of patients is needed to assess the impact of this therapy on morbidity and mortality.
© 2004 S. Karger AG, Basel
Prof. Domenico Prezioso
Via Manzoni, 71
IT–80123 Naples (Italy)
Tel. +39 081 7462606, Fax +39 081 5452959
Prof. M. Polito and G. Muzzonigro (University of Ancona, Ancona); Prof. G. Anselmo (Ospedale Civile, Treviso); Prof. C. Aragona (Ospedale Margherita, Messina); Prof. E. Bercovich (Policlinico, Sassari); Prof. A.V. Bono (Ospedale di Circolo, Varese); Dr P. Ferrari (Ospedale S. Agostino, Modena); Prof. G. Comeri (Ospedale S. Anna, Como); Prof. E. Cruciani (Ospedale Fatebenefratelli, Roma); Prof. V. Di Santo (Ospedale Regionale Miulli, Acquaviva delle Fonti); Prof. A. Durval (Ospedale Campo di Marte, Lucca); Dr M. Fini (Ospedale Civile, Imola); Dr G. Fontana (Ospedale Civile, Savigliano); Dr L. Galli (Ospedale Fatebenefratelli, Milano); Dr P. Ghiron (Ospedale degli Infermi, Biella); Prof. S. Guazzieri (Ospedale Civile, Belluno); Prof. A. Lotto (Ospedale Civile, Belluno); Prof. A. Manganelli (Ospedale Civile, Siena); Prof. G. Martorana (Università degli Studi, Bologna); Prof. F. Micali (Università di Tor Vergata, Roma); Prof. G. Mobilio (Policlinico Universitario, Verona); Prof. M. Motta (Ospedale Vittorio Emanuele, Catania); Prof. A. Pagliarulo (Università degli Studi, Bari); Dr M. Pietrantuono (Ospedale Gemma de Bonis, Cassino); Dr D. Potenzoni (Ospedale Civile, S. Secondo Parmense); Prof. P. Rigatti (Ospedale S. Raffaele, Milano); Prof. E. Usai (Ospedale S. Trinità, Cagliari).
Received: July 15, 2002
Accepted after revision: March 28, 2003
Number of Print Pages : 7
Number of Figures : 4, Number of Tables : 2, Number of References : 13
Founded 1955 by G. Peter A. Narath and Heinrich Heusser; Continued 1968–1987 by G. Mayor
Vol. 72, No. 3, Year 2004 (Cover Date: Released April 2004)
Journal Editor: D. Hauri, Zürich; M. Porena, Perugia; M.P. Wirth, Dresden
ISSN: 0042–1138 (print), 1423–0399 (Online)
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