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N Engl J Med. 2010 Apr 1;362(13):1192-202. doi: 10.1056/NEJMoa0908127.

Effect of dutasteride on the risk of prostate cancer.

Collaborators (926)

Bogado H, Borghi M, Casabé A, Juaneda R, Kobelinsky M, Mazza O, Metrebián S, Villaronga A, Costello A, Gardiner RF, Love C, Lynch WJ, Millard R, Nicol D, Stricker P, Sutherland P, Woo H, Wood S, Yaxley J, Bartsch G, Marberger M, Schmidbauer C, Studler G, Gres A, Strockyi A, Ackaert K, Boeckx G, Naudin M, Oosterlinck W, Roumeguère T, Schulman C, Tombal B, Van Erps P, Van Poppel H, Van Velthoven R, Vossaert P, Abdo JA, Atta G, Chaves O, Damião R, Koff W, Saber G, Telöken C, Alexandrov E, Mladenov D, Neykov K, Panchev P, Petkova L, Saltirov I, Aaron L, Abara E, Abramovitch A, Andreou C, Barkin J, Bell D, Bryniak S, Casey R, Chetner M, Cronje D, Dagenais L, Di Costanzo G, Egerdie RB, Eiley D, Flax S, Fleshner N, Gleave M, Goldfarb B, Jansz GK, Kinahan T, Klotz L, Kuzmarov I, Lacombe L, Lee J, Liquornik M, Love W, Maillete A, Morris B, Nickel JC, Okafo B, Paradis JB, Patrick A, Pliamm L, Pommerville P, Saad F, Simard J, Steinhoff G, Tanguay S, Tessier J, Valiquette L, Velji A, Zadra J, Huidobro Alvarado C, Lira Lueje M, Orellana N, Salazar A, Kraus O, Kjaer TB, Mommsen S, Nordling J, Arpo HE, Zirel U, Hellstrom P, Isotalo T, Kauppinen R, Laato M, Leppilahti M, Lukkarinen O, Permi J, Petas A, Rauvala M, Salo J, Taari K, Tammela T, Tuhkanen K, Al Youssef J, Allard P, Alno L, Ayed M, Baron JC, Benraid N, Billebaud T, Bittard H, Bladou F, Boccon-Gibod L, Bocquillon V, Bothorel P, Botto H, Boutin JM, Brunet P, Cadi PO, Chebil M, Colombel M, Colomes G, Defourmestraux N, Descamps F, Desgrandchamps F, Devonec M, Dufeuil P, Horchani A, Hurel JP, Iborra F, Ibrahim H, Lamotte F, Lan O, Le Portz B, Lepelley M, Lesur P, Levigne F, Loulidi S, Marc B, Masson J, Mege JL, Mhiri MN, Monod P, Mosbah AT, Mottet N, Pagès A, Perez G, Rabut B, Rischmann P, Soton G, Teillac P, Tremeaux JC, Turblin JM, Valton M, Villamizar J, Villena P, Villers A, Younes E, Bakir S, Bauer HW, Bauer L, Behrendt U, Benedic M, Benush T, Berberich H, Berse M, Binder M, Bischoff W, Bluemlein HM, Boehle A, Boergmann H, Bohnenkamp A, Boness J, Brands F, Braun HC, Bruns T, Bruske T, Buecherl R, Decker M, Degen S, Demmler I, Dierkopf W, Dubiel J, Eckert R, Eichler U, Farahmandi R, Fehsel F, Frankenau P, Fuhrberg J, Girke C, Glass M, Gleissner J, Graf C, Gratzke P, Groeschel P, Haas W, Hagel WC, Hamann M, Hechelmann W, Heidrich A, Heisler M, Helmbrecht J, Henke G, Henschel T, Hentschke T, Herrmann B, Herrmann K, Herzig J, Himstedt HW, Hofer J, Hoffmann M, Hollberg H, Hübner A, Hudemann B, Jacobi G, Jansen H, Johann KU, Karras R, Karstedt H, Keipert D, Kellner T, Kennerknecht M, Kern J, Klammert R, Köferl F, Konert J, Köttig T, Kriegmair M, Kube U, Kublanck A, Kuehne A, Kuetgens P, Kühn SH, Kühne F, Kunz J, Kutscher KR, Kwela M, Laag R, Langer KC, Langhorst W, Laval KU, Leonhard W, Lock UC, Lunz C, Malsy-Mink P, Marin J, Markow M, Massek F, Matz U, Meisel J, Mertins B, Michel W, Miersch WD, Mohr S, Müller B, Müller D, Müller H, Mumperow E, Münch A, Nette U, Netzer M, Neubauer H, Nietzsch D, Ostwald R, Pauthner H, Petry A, Pielmeier T, Plate H, Ploss HJ, Quack T, Quast D, Radlmaier M, Radulescu M, Rehm B, Renner P, Rollenhagen AR, Romitan-Baum R, Rompf M, Rothe P, Rotter C, Rüssel C, Rüth J, Sablotny J, Schachschneider H, Schäning M, Schaub W, Scheffler M, Scheunpflug K, Schewe J, Schlichter A, Schmidt JJ, Schmidt PS, Schneider B, Schneider J, Schneider T, Schreieer H, Schroeder A, Schrötter U, Schulz T, Schulze M, Schwegmann A, Simson G, Sippel F, Solga M, Speck T, Stahl HD, Surrey HW, Szymula S, Telle J, Thomas S, Uellendahl K, Umbreit O, Unger U, von Keitz A, von Kügelgen T, von Ostau C, Wächter S, Walter T, Warnack W, Weck B, Weitz P, Weizert P, Wengler R, Willgerodt J, Winter M, Wurschi M, Zellner M, Ziegner D, Ziemacki A, Zillmann R, Zürner T, Barbalias G, Hatzichristou D, Kalafatis P, Karanastasis D, Katsifotis H, Kokotas N, Liatsikos E, Malovrouvas D, Margaritopoulou A, Melekos M, Poulias I, Salpigidis G, Sofikitis N, Sofras F, Touloupidis S, Tsidavis A, Fehér J, Kisbenedek L, Romics I, Fitzpatrick J, McDermott TE, Sweeney P, Bercovich E, Caggiano S, D'Armiento M, DiSilverio F, LaRosa P, Manieri C, Mensi M, Montrosi F, Motta M, Pagliarule A, Pecoraro G, Raciti G, Selli C, Usai E, Usai P, Akaza H, Nakatsu H, Sagiyama K, Sakai H, Sakamoto S, Tsukamoto T, Dale R, Gilis D, Gordins S, Hohlovs A, Karulis A, Vjaters E, Bekeris T, Cerniauskiene A, Gaizauskas S, Jankevicius F, Jievaltas M, Palaikiene Z, Stakenas A, Ulys A, Calderon Ferro F, Calvo-Domínguez D, Carvajal-García R, Feria-Bernal G, Lugo-Nevarez MA, Manzanilla-Garcia HA, Martínez-Castro MA, Pacheco-Gahbler C, Rodriguez-Rivera JA, Barten EJ, Blitz W, Cornel EB, de Bruin MJ, de Lange DC, Kil PJ, Koldewijn EL, Kropman RF, Kupfer HW, Leenarts JA, Mulders PF, Schrier BP, Schröder FH, Timmer EC, van Andel G, Van Aubel OG, van Balken MR, van Berkel JT, van Haarst EP, van Vierssen T, Oncko B, Vergunst H, Vijverberg PL, Bary P, Davidson P, Gilling P, Meffan P, Nixon T, Tuckey J, Andersen M, Beisland HO, Bjerklung J, Truls E, Hoeg OM, Øgreid P, Omland H, Borkowski A, Duda W, Galezia M, Jarzemski P, Kwiatkowski S, Meller J, Mikszewica A, Niezabitowski J, Roslan M, Sikorski A, Sokolowski J, Szkarlat K, Tereszkiewicz J, Pinheiro JC, Pinheiro LC, de Oliveira AF, Días JR, Gomes C, Guimarães M, Ferreira AM, Monteiro H, Pires MB, Rolo F, Morales-Ramírez JO, Ambert V, Bina MN, Calomfirescu N, Aljaev Y, Al-Shukri S, Apolikhin O, Gorilovsky L, Grigoriev M, Krupin V, Lopatkin N, Mazo E, Petrov S, Shaplygin L, Breza J, Kliment J, Bizjak I, Kisner K, Sedmak B, Vodopija N, Bongers M, Glocer J, Haffejee M, Harden P, Heyns C, Mackenzie T, Reif S, Van der Walt JS, Webb G, Astobieta A, Azparren J, Benejam J, Cabezudo I, Castiñeiras J, Chéchile Toniolo G, Cuya L, Díaz JL, Franco E, Gallego Sánchez JA, Galvis Palau F, Garcia Matres MJ, García Pérez M, Gelabert Mas A, Gimeno Collado A, Hevia Suarez M, Kilani Elmasri S, Llorente C, López Alcina E, Lopez-Alda A, Lorente Garin JA, Morales AM, Martinez Javaloyas J, Martinez-Sagarra Oceja JM, Martin-Marquina Aspiunza A, Montesino M, Morales Lopez A, Morote J, Mouaffak N, Nogueras MA, Paños Lozano P, Pedro, Pastor Sempere F, Rodriguez P, Romero J, Saladie JM, Sanchez Chapado M, Sanz Jaca JP, Serrallach Milá N, Silmi Moyano A, Solsona E, Tallada Buñuel M, Teba del Pino F, Unda Urzaiz M, Villavicencio H, Zaragoza J, Damber JE, Folmerz P, Gedda S, Magnusson B, Norming U, Paradis A, Pileblad E, Sandin T, Schain M, Stattin P, Ströberg P, Wagrell L, Waldén M, Mauritz, Wang YH, Willén M, Eberle J, Eigenmann J, Gunst M, Gygi C, Heering F, Michaelis WE, Mottax A, Recker F, Rochat CH, Trinkler F, Akdas A, Atan A, Ozcan F, Ozen H, Abdulhakim E, Akhtar M, Anderson C, Barnes D, Carter P, Chinegwundoh F, Cole O, Cumming J, Donnachie H, Emberton M, Fraser J, Gillatt D, Gonzalez V, Govindraj S, Hamilton G, Hehir M, Jaganathan R, Jassel G, Javle PM, Kaisary A, Kanagasundaram S, Khursheed M, Leung H, Liu S, MacDermott J, Maroni J, Martin R, Matanhelia SS, McClinton S, McFarlane J, McInerney P, McNeill SA, McNicholas T, Meddings R, Mellon J, Miller P, O'Reilly P, Paul A, Pavel I, Pawa R, Perrapato S, Persad R, Philp T, Pickard R, Pttman W, Pitts C, Pocock R, Puri R, Raja A, Rao P, Robinson J, Robinson J, Saeed I, Salman M, Sarmiento R, Schwaibold H, Sethia K, Sharma N, Shaw H, Speakman M, Taylor S, Thomas H, Lesovoy V, Adams G, Altman D, Andriole G, Apaydin A, Aronson W, Auerback S, Baier C, Bailen J, Baker W, Bannow J, Bardot S, Barham R, Barkley C, Barnswell C, Basler J, Bass J, Baum N, Baumann L, Beam T, Belkoff L, Benaim E, Benitez O, Bergner D, Bergreen P, Bernstein G, Bernstein M, Bidair M, Blath R, Bobrowski J, Bock D, Bondhus M, Bowling B, Bracken RB, Brawer M, Brodak P, Broker R, Brooks S, Brosman S, Brown D, Brown G, Brown J, Bruno D, Bryant K, Bundrick WS, Burke WR, Camps J Jr, Capo J Jr, Castellanos R, Chang S, Childs S, Ching V, Chinn S, Chiou R, Chiura A, Chodak G, Chu F, Chung S, Clark R, Clark W, Cochran J, Cohen J, Cohen S, Cole F, Concepcion R, Cook D, Corman J, Corral D, Costa F, Cowan B, Coyle C, Crawford D, Cudecki J, Daniels M, Davis B, DeFelippo JD, Deichmann R, Diener C, Diokno A, Drehobl M, Dula E, Edelman R, Mitchell, Ellis D, Ellis W, Eure G, Fay R, Fei R, Feldman R, Finkbeiner A, Fishman R, Fitch W, Forrest J, Freedberg P, Freedman S, Freeman J, Fromang D, Galdieri L, Gange S, Gardner T, Garvin D, Gassner L, Gaylis F, Gburek B, Gerber G, Gershman A, Ghavamian R, Gill H, Gittelman M, Gleason D, Gluckman G, Godschalk M, Goldberg K, Green B, Greene G, Greengold R, Grubb R 3rd, Grubman J, Guice S, Hagan M, Hagood P, Hamad M, Hamway S, Harkaway R, Harper W, Harris R, Hatcher P, Henderson R, Hertzman B, Hey W, Hezmall H, Hollowell C, Hoppmann H, Houser E, Hudnall C, Husain A, Igel T, Iliades C, Immergut M, Isen J, Israeli R, Jablonski D, Johnson J, Kaempf M, Kaminetsky J, Kane R, Kaplan M, Kaplinsky R, Karlin G, Karsh L, Katz PG, Kauder D, Kaufman J, Kaufman R, Keanne T, Killorin W, Kistein S, King E, Kleer E, Klimbert I, Klorfein E, Kornitzer G, Koukol S, Kriteman L, Kronhaus R, Lasky R, Lawton S, Levine M, Liberman S, Libin M, Lieber M, Lieberman M, Lipkis D, Lipsitz D, Lochner J, Lubin B, Lugg J, Lynch D, Macaluso J Jr, Maggiacomo F, Mandel E, Manion S, Marks J, Marks L, Mason T, McLeod D, McMurray J, Mehlhaff B, Mellinger B, Menashe D, Miller D, Mirelman S, Mitcheson H, Mobley D, Modarelli R, Mollen M, Monath JR, Monnig W, Moore J, Morgenstern J, Moseley W, Murdock M, Murphy G, Myers R, Naslund M, Nelson J, Neustein P, Niku S, O'Leary M, O'Reilly K, Oselinksky D, Parham R, Parr G, Parries G, Parulkar B, Passarella M, Pathroff R, Patterson T, Peterson A, Pettaway C, Pinto A, Price V, Puopolo A, Rainwater L, Ralph L, Ramos C, Rapo S, Ray P, Reed D, Reese C, Riff D, Ritter H Jr, Roberts B, Roehrborn C, Roper R, Saslawsky M, Sawczuk I, Schiff W, Schwartz E, Sharifi R, Shinohara K, Sidhorn A, Sieber P, Sigman D, Singh E, Sipio J, Slaski A, Slawin K, Slutsky J, Snyder J, Spigner D, Spirnak J, Stallings J, Steidle C, Stein B, Stout D, Streisand S, Teigland C, Thompson D, Thrasher JB, Threatt C, Tiffany P, Tomasic N, Tomera K, Torgerson E, Tortora F, Tremann J, Troia P, Tutrone R, Twidwell J, Usow B, Utz W, Van Cleef M, Wachs B, Walther P, Walton J, Wei D, West J Jr, White CF, Whiting J, Whitlock N, Wiatrak ML, Wieskopf B, Wurzel R, Yavari M, Yeoman G, Young J, Young J, Zacharias A, Zagula JZ, Zinner N, Zusman E.

Author information

  • 1Division of Urology, Washington University School of Medicine in St. Louis, St. Louis, MO 63110, USA. andrioleg@wustl.edu

Abstract

BACKGROUND:

We conducted a study to determine whether dutasteride reduces the risk of incident prostate cancer, as detected on biopsy, among men who are at increased risk for the disease.

METHODS:

In this 4-year, multicenter, randomized, double-blind, placebo-controlled, parallel-group study, we compared dutasteride, at a dose of 0.5 mg daily, with placebo. Men were eligible for inclusion in the study if they were 50 to 75 years of age, had a prostate-specific antigen (PSA) level of 2.5 to 10.0 ng per milliliter, and had had one negative prostate biopsy (6 to 12 cores) within 6 months before enrollment. Subjects underwent a 10-core transrectal ultrasound-guided biopsy at 2 and 4 years.

RESULTS:

Among 6729 men who underwent a biopsy or prostate surgery, cancer was detected in 659 of the 3305 men in the dutasteride group, as compared with 858 of the 3424 men in the placebo group, representing a relative risk reduction with dutasteride of 22.8% (95% confidence interval, 15.2 to 29.8) over the 4-year study period (P<0.001). Overall, in years 1 through 4, among the 6706 men who underwent a needle biopsy, there were 220 tumors with a Gleason score of 7 to 10 among 3299 men in the dutasteride group and 233 among 3407 men in the placebo group (P=0.81). During years 3 and 4, there were 12 tumors with a Gleason score of 8 to 10 in the dutasteride group, as compared with only 1 in the placebo group (P=0.003). Dutasteride therapy, as compared with placebo, resulted in a reduction in the rate of acute urinary retention (1.6% vs. 6.7%, a 77.3% relative reduction). The incidence of adverse events was similar to that in studies of dutasteride therapy for benign prostatic hyperplasia, except that in our study, as compared with previous studies, the relative incidence of the composite category of cardiac failure was higher in the dutasteride group than in the placebo group (0.7% [30 men] vs. 0.4% [16 men], P=0.03).

CONCLUSIONS:

Over the course of the 4-year study period, dutasteride reduced the risk of incident prostate cancer detected on biopsy and improved the outcomes related to benign prostatic hyperplasia. (ClinicalTrials.gov number, NCT00056407.)

2010 Massachusetts Medical Society

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PMID:
20357281
[PubMed - indexed for MEDLINE]
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