BACKGROUND: Prostate cancer screening among the general population is highly debatable. Nevertheless, screening among high-risk groups is appealing. Prior data suggests that men carrying mutations in the BRCA1& 2 genes may be at increased risk of developing prostate cancer. Additionally, they appear to develop prostate cancer at a younger age and with a more aggressive course. However, prior studies did not systematically perform prostate biopsies and thus cannot determine the true prevalence of prostate cancer in this population. METHODS: This will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition. The target population is males (40-70 year old) carrying a BRCA1 and/or BRCA2 germ line mutation. They will be identified via our Genetic counseling unit. All men after signing an informed consent will undergo the following tests: PSA, free to total PSA, MRI of prostate and prostate biopsy. The primary endpoint will be to estimate the prevalence, stage and grade of prostate cancer in this population. Additionally, the study aims to estimate the impact of these germ line mutations on benign prostatic hyperplasia. Furthermore, this study aims to create a bio-bank of tissue, urine and serum of this unique cohort for future investigations. Finally, this study will identify an inception cohort for future interventional studies of primary and secondary prevention. DISCUSSION: The proposed research is highly translational and focuses not only on the clinical results, but on the future specimens that will be used to advance our understanding of prostate cancer patho-physiology. Most importantly, these high-risk germ-line mutation carriers are ideal candidates for primary and secondary prevention initiatives. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02053805.
BACKGROUND:Prostate cancer screening among the general population is highly debatable. Nevertheless, screening among high-risk groups is appealing. Prior data suggests that men carrying mutations in the BRCA1& 2 genes may be at increased risk of developing prostate cancer. Additionally, they appear to develop prostate cancer at a younger age and with a more aggressive course. However, prior studies did not systematically perform prostate biopsies and thus cannot determine the true prevalence of prostate cancer in this population. METHODS: This will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition. The target population is males (40-70 year old) carrying a BRCA1 and/or BRCA2 germ line mutation. They will be identified via our Genetic counseling unit. All men after signing an informed consent will undergo the following tests: PSA, free to total PSA, MRI of prostate and prostate biopsy. The primary endpoint will be to estimate the prevalence, stage and grade of prostate cancer in this population. Additionally, the study aims to estimate the impact of these germ line mutations on benign prostatic hyperplasia. Furthermore, this study aims to create a bio-bank of tissue, urine and serum of this unique cohort for future investigations. Finally, this study will identify an inception cohort for future interventional studies of primary and secondary prevention. DISCUSSION: The proposed research is highly translational and focuses not only on the clinical results, but on the future specimens that will be used to advance our understanding of prostate cancer patho-physiology. Most importantly, these high-risk germ-line mutation carriers are ideal candidates for primary and secondary prevention initiatives. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02053805.
Authors: Stephen M Edwards; Zsofia Kote-Jarai; Julia Meitz; Rifat Hamoudi; Questa Hope; Peter Osin; Rachel Jackson; Christine Southgate; Rashmi Singh; Alison Falconer; David P Dearnaley; Audrey Ardern-Jones; Annette Murkin; Anna Dowe; Jo Kelly; Sue Williams; Richard Oram; Margaret Stevens; Dawn M Teare; Bruce A J Ponder; Simon A Gayther; Doug F Easton; Rosalind A Eeles Journal: Am J Hum Genet Date: 2002-12-09 Impact factor: 11.025
Authors: B Djavan; M Waldert; A Zlotta; P Dobronski; C Seitz; M Remzi; A Borkowski; C Schulman; M Marberger Journal: J Urol Date: 2001-09 Impact factor: 7.450
Authors: Anita V Mitra; Elizabeth K Bancroft; Yolanda Barbachano; Elizabeth C Page; C S Foster; C Jameson; G Mitchell; G J Lindeman; A Stapleton; G Suthers; D G Evans; D Cruger; I Blanco; C Mercer; J Kirk; L Maehle; S Hodgson; L Walker; L Izatt; F Douglas; K Tucker; H Dorkins; V Clowes; A Male; A Donaldson; C Brewer; R Doherty; B Bulman; P J Osther; M Salinas; D Eccles; K Axcrona; I Jobson; B Newcombe; C Cybulski; W S Rubinstein; S Buys; S Townshend; E Friedman; S Domchek; T Ramon Y Cajal; A Spigelman; S H Teo; N Nicolai; N Aaronson; A Ardern-Jones; C Bangma; D Dearnaley; J Eyfjord; A Falconer; H Grönberg; F Hamdy; O Johannsson; V Khoo; Z Kote-Jarai; H Lilja; J Lubinski; J Melia; C Moynihan; S Peock; G Rennert; F Schröder; P Sibley; M Suri; P Wilson; Y J Bignon; S Strom; M Tischkowitz; A Liljegren; D Ilencikova; A Abele; K Kyriacou; C van Asperen; L Kiemeney; D F Easton; Rosalind A Eeles Journal: BJU Int Date: 2010-09-14 Impact factor: 5.588
Authors: Fritz H Schröder; Jonas Hugosson; Monique J Roobol; Teuvo L J Tammela; Stefano Ciatto; Vera Nelen; Maciej Kwiatkowski; Marcos Lujan; Hans Lilja; Marco Zappa; Louis J Denis; Franz Recker; Alvaro Páez; Liisa Määttänen; Chris H Bangma; Gunnar Aus; Sigrid Carlsson; Arnauld Villers; Xavier Rebillard; Theodorus van der Kwast; Paula M Kujala; Bert G Blijenberg; Ulf-Hakan Stenman; Andreas Huber; Kimmo Taari; Matti Hakama; Sue M Moss; Harry J de Koning; Anssi Auvinen Journal: N Engl J Med Date: 2012-03-15 Impact factor: 91.245
Authors: Gerald L Andriole; E David Crawford; Robert L Grubb; Saundra S Buys; David Chia; Timothy R Church; Mona N Fouad; Edward P Gelmann; Paul A Kvale; Douglas J Reding; Joel L Weissfeld; Lance A Yokochi; Barbara O'Brien; Jonathan D Clapp; Joshua M Rathmell; Thomas L Riley; Richard B Hayes; Barnett S Kramer; Grant Izmirlian; Anthony B Miller; Paul F Pinsky; Philip C Prorok; John K Gohagan; Christine D Berg Journal: N Engl J Med Date: 2009-03-18 Impact factor: 91.245
Authors: Anna Marie Mulligan; Fergus J Couch; Daniel Barrowdale; Susan M Domchek; Diana Eccles; Heli Nevanlinna; Susan J Ramus; Mark Robson; Mark Sherman; Amanda B Spurdle; Barbara Wappenschmidt; Andrew Lee; Lesley McGuffog; Sue Healey; Olga M Sinilnikova; Ramunas Janavicius; Thomas vO Hansen; Finn C Nielsen; Bent Ejlertsen; Ana Osorio; Iván Muñoz-Repeto; Mercedes Durán; Javier Godino; Maroulio Pertesi; Javier Benítez; Paolo Peterlongo; Siranoush Manoukian; Bernard Peissel; Daniela Zaffaroni; Elisa Cattaneo; Bernardo Bonanni; Alessandra Viel; Barbara Pasini; Laura Papi; Laura Ottini; Antonella Savarese; Loris Bernard; Paolo Radice; Ute Hamann; Martijn Verheus; Hanne E J Meijers-Heijboer; Juul Wijnen; Encarna B Gómez García; Marcel R Nelen; C Marleen Kets; Caroline Seynaeve; Madeleine M A Tilanus-Linthorst; Rob B van der Luijt; Theo van Os; Matti Rookus; Debra Frost; J Louise Jones; D Gareth Evans; Fiona Lalloo; Ros Eeles; Louise Izatt; Julian Adlard; Rosemarie Davidson; Jackie Cook; Alan Donaldson; Huw Dorkins; Helen Gregory; Jacqueline Eason; Catherine Houghton; Julian Barwell; Lucy E Side; Emma McCann; Alex Murray; Susan Peock; Andrew K Godwin; Rita K Schmutzler; Kerstin Rhiem; Christoph Engel; Alfons Meindl; Ina Ruehl; Norbert Arnold; Dieter Niederacher; Christian Sutter; Helmut Deissler; Dorothea Gadzicki; Karin Kast; Sabine Preisler-Adams; Raymonda Varon-Mateeva; Ines Schoenbuchner; Britta Fiebig; Wolfram Heinritz; Dieter Schäfer; Heidrun Gevensleben; Virginie Caux-Moncoutier; Marion Fassy-Colcombet; François Cornelis; Sylvie Mazoyer; Mélanie Léoné; Nadia Boutry-Kryza; Agnès Hardouin; Pascaline Berthet; Danièle Muller; Jean-Pierre Fricker; Isabelle Mortemousque; Pascal Pujol; Isabelle Coupier; Marine Lebrun; Caroline Kientz; Michel Longy; Nicolas Sevenet; Dominique Stoppa-Lyonnet; Claudine Isaacs; Trinidad Caldes; Miguel de la Hoya; Tuomas Heikkinen; Kristiina Aittomäki; Ignacio Blanco; Conxi Lazaro; Rosa B Barkardottir; Penny Soucy; Martine Dumont; Jacques Simard; Marco Montagna; Silvia Tognazzo; Emma D'Andrea; Stephen Fox; Max Yan; Tim Rebbeck; Olufunmilayo Olopade; Jeffrey N Weitzel; Henry T Lynch; Patricia A Ganz; Gail E Tomlinson; Xianshu Wang; Zachary Fredericksen; Vernon S Pankratz; Noralane M Lindor; Csilla Szabo; Kenneth Offit; Rita Sakr; Mia Gaudet; Jasmine Bhatia; Noah Kauff; Christian F Singer; Muy-Kheng Tea; Daphne Gschwantler-Kaulich; Anneliese Fink-Retter; Phuong L Mai; Mark H Greene; Evgeny Imyanitov; Frances P O'Malley; Hilmi Ozcelik; Gordon Glendon; Amanda E Toland; Anne-Marie Gerdes; Mads Thomassen; Torben A Kruse; Uffe Birk Jensen; Anne-Bine Skytte; Maria A Caligo; Maria Soller; Karin Henriksson; von Anna Wachenfeldt; Brita Arver; Marie Stenmark-Askmalm; Per Karlsson; Yuan Chun Ding; Susan L Neuhausen; Mary Beattie; Paul D P Pharoah; Kirsten B Moysich; Katherine L Nathanson; Beth Y Karlan; Jenny Gross; Esther M John; Mary B Daly; Saundra M Buys; Melissa C Southey; John L Hopper; Mary Beth Terry; Wendy Chung; Alexander F Miron; David Goldgar; Georgia Chenevix-Trench; Douglas F Easton; Irene L Andrulis; Antonis C Antoniou Journal: Breast Cancer Res Date: 2011-11-02 Impact factor: 6.466
Authors: Elizabeth K Bancroft; Elizabeth C Page; Elena Castro; Hans Lilja; Andrew Vickers; Daniel Sjoberg; Melissa Assel; Christopher S Foster; Gillian Mitchell; Kate Drew; Lovise Mæhle; Karol Axcrona; D Gareth Evans; Barbara Bulman; Diana Eccles; Donna McBride; Christi van Asperen; Hans Vasen; Lambertus A Kiemeney; Janneke Ringelberg; Cezary Cybulski; Dominika Wokolorczyk; Christina Selkirk; Peter J Hulick; Anders Bojesen; Anne-Bine Skytte; Jimmy Lam; Louise Taylor; Rogier Oldenburg; Ruben Cremers; Gerald Verhaegh; Wendy A van Zelst-Stams; Jan C Oosterwijk; Ignacio Blanco; Monica Salinas; Jackie Cook; Derek J Rosario; Saundra Buys; Tom Conner; Margreet G Ausems; Kai-ren Ong; Jonathan Hoffman; Susan Domchek; Jacquelyn Powers; Manuel R Teixeira; Sofia Maia; William D Foulkes; Nassim Taherian; Marielle Ruijs; Apollonia T Helderman-van den Enden; Louise Izatt; Rosemarie Davidson; Muriel A Adank; Lisa Walker; Rita Schmutzler; Kathy Tucker; Judy Kirk; Shirley Hodgson; Marion Harris; Fiona Douglas; Geoffrey J Lindeman; Janez Zgajnar; Marc Tischkowitz; Virginia E Clowes; Rachel Susman; Teresa Ramón y Cajal; Nicholas Patcher; Neus Gadea; Allan Spigelman; Theo van Os; Annelie Liljegren; Lucy Side; Carole Brewer; Angela F Brady; Alan Donaldson; Vigdis Stefansdottir; Eitan Friedman; Rakefet Chen-Shtoyerman; David J Amor; Lucia Copakova; Julian Barwell; Veda N Giri; Vedang Murthy; Nicola Nicolai; Soo-Hwang Teo; Lynn Greenhalgh; Sara Strom; Alex Henderson; John McGrath; David Gallagher; Neil Aaronson; Audrey Ardern-Jones; Chris Bangma; David Dearnaley; Philandra Costello; Jorunn Eyfjord; Jeanette Rothwell; Alison Falconer; Henrik Gronberg; Freddie C Hamdy; Oskar Johannsson; Vincent Khoo; Zsofia Kote-Jarai; Jan Lubinski; Ulrika Axcrona; Jane Melia; Joanne McKinley; Anita V Mitra; Clare Moynihan; Gad Rennert; Mohnish Suri; Penny Wilson; Emma Killick; Sue Moss; Rosalind A Eeles Journal: Eur Urol Date: 2014-01-15 Impact factor: 20.096
Authors: S A Narod; S Neuhausen; G Vichodez; S Armel; H T Lynch; P Ghadirian; S Cummings; O Olopade; D Stoppa-Lyonnet; F Couch; T Wagner; E Warner; W D Foulkes; H Saal; J Weitzel; A Tulman; A Poll; R Nam; P Sun; Jessica Danquah; Susan Domchek; Nadine Tung; Peter Ainsworth; Douglas Horsman; Charmaine Kim-Sing; Christine Maugard; Andrea Eisen; Mary Daly; Wendy McKinnon; Marie Wood; Claudine Isaacs; Dawna Gilchrist; Beth Karlan; Raluca Nedelcu; Wendy Meschino; Judy Garber; Barbara Pasini; Siranoush Manoukian; Christina Bellati Journal: Br J Cancer Date: 2008-06-24 Impact factor: 7.640
Authors: Talia Golan; Maria Raitses-Gurevich; Robin K Kelley; Andrea G Bocobo; Ayelet Borgida; Rachna T Shroff; Spring Holter; Steven Gallinger; Daniel H Ahn; Dan Aderka; Jain Apurva; Tanois Bekaii-Saab; Eitan Friedman; Milind Javle Journal: Oncologist Date: 2017-05-09