Prostate Cancer Clinical Trial

International Registry for Men With Advanced Prostate Cancer (IRONMAN)

Summary

Our intent is to establish the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000 men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to establish a population-based registry and recruit patients across academic and community practices from Australia, Brazil, Canada, Ireland, Jamaica, Nigeria, Norway, Spain, Sweden, Switzerland, the United Kingdom (UK), and the US. Target accrual number and number of participating sites are subject to change based on accrual, funding, and interest in participation by other international sites. This cohort study will facilitate a better understanding of the variation in care and treatment of advanced prostate cancer across countries and across academia and community based practices.

Detailed data will be collected from patients at study enrollment and then during follow-up, for a minimum of five years. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and PROMs.

PROMs questionnaires will be collected at enrollment and every three months thereafter.

Physician Questionnaires will be collected from all participating sites at patient enrollment, time of first change in treatment and/or one year follow-up, at each subsequent change of treatment, and discontinuation of treatment.

As such, this registry will help identify the treatment sequences or combinations that optimize overall survival and PROMs for men with mHSPC and M0/M1 CRPC. By collecting blood at enrollment, time of first change in treatment and/or one year follow-up (plasma, cell free DNA, buffy coat / RNA), this registry will further identify and validate molecular phenotypes of disease that predict response and resistance to specific therapeutics. Additionally, every effort will be made to collect blood specimen at each subsequent change in treatment due to progression of disease. When feasible, existing tumor tissue may be collected for correlation with described blood based studies. All samples will be used for future research. This cohort study will provide the research community with a unique biorepository to identify biomarkers of treatment response and resistance.

View Eligibility Criteria

Eligibility Criteria

• Willing and able to provide written informed consent and privacy authorization for the release of personal health information.

NOTE: Privacy authorization may be either included in the informed consent or obtained separately.

Males 21 years of age and above
Histological or cytological confirmed prostate adenocarcinoma from TRUS biopsy, radical prostatectomy or TURP Or Documented histopathology or cytopathology of prostate adenocarcinoma from a biopsy of a metastatic site Or Metastatic disease typical of prostate cancer (i.e., involving bone or pelvic lymph nodes or para-aortic lymph nodes) AND a serum concentration of PSA >20ng/mL
No previous diagnosis of a second, non-prostate malignancy that requires additional systemic therapy except cancer in situ of bladder and basal cell cancer of skin

Study is for people with:

Prostate Cancer

Estimated Enrollment:

5000

Study ID:

NCT03151629

Recruitment Status:

Recruiting

Sponsor:

Prostate Cancer Clinical Trials Consortium

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There are 61 Locations for this study

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University of Alabama-Birmingham
Birmingham Alabama, 35233, United States More Info
Eddy Yang, MD, PhD
Contact
Eddy Yang, MD, PhD
Principal Investigator
University of California - Los Angeles
Los Angeles California, 90024, United States More Info
Allan Pantuck, MD
Contact
Allan Pantuck, MD
Principal Investigator
University of California San Diego
San Diego California, 92037, United States More Info
Rana McKay, MD
Contact
Rana McKay, MD
Principal Investigator
Yale University
New Haven Connecticut, 06502, United States More Info
Daniel Petrylak, MD
Contact
[email protected]
Daniel Petrylak, MD
Principal Investigator
University of Florida
Gainesville Florida, 32611, United States More Info
Kethandapatti Balaji, MD
Contact
[email protected]
Kethandapatti Balaji, PhD
Principal Investigator
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Monica Chatwal, MD
Contact
[email protected]
Morehouse School of Medicine
Atlanta Georgia, 30310, United States More Info
James Lillard, PhD
Contact
[email protected]
James Lillard, PhD
Principal Investigator
Emory Winship Cancer Institute
Atlanta Georgia, 30322, United States More Info
Mehmet Bilen, MD
Contact
Mehmet Bilen, MD
Principal Investigator
University of Illinois at Chicago
Chicago Illinois, 60607, United States More Info
Daniel Moreira, MD
Contact
[email protected]
Daniel Moreira, MD
Principal Investigator
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago Illinois, 60611, United States More Info
David Vanderweele, MD
Contact
[email protected]
David Vanderweele, MD
Principal Investigator
University of Chicago
Chicago Illinois, 60637, United States More Info
Russell Szmulewitz
Contact
[email protected]
Kishwaukee Cancer Center
DeKalb Illinois, 60115, United States More Info
Christopher George, MD
Contact
[email protected]
Christopher George, MD
Principal Investigator
Delnor Cancer Center
Geneva Illinois, 60134, United States More Info
Christopher George, MD
Contact
[email protected]
Christopher George, MD
Principal Investigator
Warrenville Cancer Center
Warrenville Illinois, 60555, United States More Info
Christopher George, MD
Contact
[email protected]
Christopher George, MD
Principal Investigator
Tulane University
New Orleans Louisiana, 70118, United States More Info
Pedro Barata, MD
Contact
Pedro Barata, MD
Principal Investigator
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore Maryland, 21231, United States More Info
Mark Markowski
Contact
[email protected]
Chesapeake Urology Associates
Towson Maryland, 21204, United States More Info
Ronald Tutrone, MD
Contact
Ronald Tutrone, MD
Principal Investigator
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Mark Pomerantz
Contact
[email protected]
University of Michigan
Ann Arbor Michigan, 48109, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States More Info
Elizabeth Heath
Contact
[email protected]
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States More Info
John Henegan, MD
Contact
[email protected]
John Henegan, MD
Principal Investigator
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn New York, 11215, United States More Info
Scott Tagawa, MD
Contact
[email protected]
Scott Tagawa, MD
Principal Investigator
Roswell Park Comprehensive Cancer Center
Buffalo New York, 14203, United States More Info
Gurkamal Chatta, MD
Contact
Gurkamal Chatta, MD
Principal Investigator
VA Western New York Healthcare System
Buffalo New York, 14215, United States More Info
James Conway, MD
Contact
[email protected]
James Conway, MD
Principal Investigator
Columbia University Medical Center
New York New York, 10032, United States More Info
Mark Stein, MD
Contact
Mark Stein, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Dana RathKopf
Contact
[email protected]
Weill Cornell Medical Center
New York New York, 10065, United States More Info
Scott Tagawa, MD
Contact
Scott Tagawa, MD
Principal Investigator
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27514, United States More Info
Young Whang
Contact
[email protected]
Durham VA Medical Center
Durham North Carolina, 27705, United States More Info
Rhonda Bitting, MD
Contact
[email protected]
Rhonda Bitting, MD
Principal Investigator
Duke Cancer Network
Durham North Carolina, 27710, United States More Info
Tian Zhang, MD
Contact
Tian Zhang, MD
Principal Investigator
Duke University
Durham North Carolina, 27710, United States More Info
Dan George
Contact
[email protected]
Oregon Health & Science University Hospital
Portland Oregon, 97239, United States More Info
Alexandra Sokolova
Contact
[email protected]
Sokolova
Principal Investigator
Doylestown Health
Doylestown Pennsylvania, 18901, United States More Info
Mitchell Alden, MD
Contact
[email protected]
Mitchell Alden
Principal Investigator
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States More Info
William Kelly
Contact
[email protected]
Fox Chase Cancer Center - Temple Health
Philadelphia Pennsylvania, 19134, United States More Info
Camille Ragin, PhD
Contact
[email protected]
Camille Ragin, PhD
Principal Investigator
Reading Health System
West Reading Pennsylvania, 19611, United States More Info
Terrence Cescon, MD
Contact
[email protected]
Terrence Cescon, MD
Principal Investigator
Ralph H. Johnson VA Medical Center
Charleston South Carolina, 29401, United States More Info
Stephen Savage, MD
Contact
[email protected]
Stephen Savage, MD
Principal Investigator
William Jennings Bryan Dorn VAMC
Columbia South Carolina, 29209, United States
Memphis VA Medical Center
Memphis Tennessee, 38104, United States More Info
Alva Weir, MD
Contact
[email protected]
Baylor College of Medicine
Houston Texas, 77030, United States More Info
Martha Mims, MD, PhD
Principal Investigator
University of Virginia
Charlottesville Virginia, 22903, United States More Info
Robert Dreicer
Contact
[email protected]
University of Washington Medical Center
Seattle Washington, 98195, United States More Info
Heather Cheng, MD
Contact
Heather Cheng, MD
Principal Investigator
University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53705, United States More Info
Hamid Emamekhoo, MD
Contact
Hamid Emamekhoo, MD
Principal Investigator
Royal Brisbane & Women's Hospital
Herston Brisbane, , Australia More Info
Ian D Davis, MD
Contact
[email protected]
Ian D Davis, MD
Principal Investigator
St. Vincent's Hospital Sydney
Darlinghurst New South Wales, , Australia More Info
Anthony Joshua, MD
Contact
[email protected]
Anthony Joshua, MD
Principal Investigator
Macquarie University
Sydney New South Wales, , Australia More Info
Howard Gurney
Contact
Howard Gurney
Principal Investigator
Westmead Hospital
Sydney New South Wales, , Australia More Info
Howard Gurney
Contact
Howard Gurney
Principal Investigator
Redland Hospital
Cleveland Queensland, , Australia More Info
Ian Vela
Contact
Ian Vela
Principal Investigator
Princess Alexandra Hospital
Woolloongabba Queensland, , Australia More Info
Ian Vela
Contact
Ian Vela
Principal Investigator
Eastern Health (Box Hill Hospital)
Box Hill Victoria, , Australia More Info
Ian Davis
Contact
Ian Davis
Principal Investigator
Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia More Info
Declan Murphy, MD
Contact
[email protected]
Declan Murphy
Principal Investigator
Epworth Healthcare
Mount Waverley Victoria, 3149, Australia More Info
Ben Tran, MD
Contact
[email protected]
Ben Tran, MD
Principal Investigator
Australian Prostate Centre
Melbourne N. , , Australia More Info
Philip Dundee, MD
Contact
[email protected]
Philip Dundee, MD
Principal Investigator
Australian Urology Associates
Melbourne , , Australia More Info
Mark Frydenberg
Contact
Mark Frydenberg
Principal Investigator
The University of the West Indies - Cave Hill Campus
Bridgetown , , Barbados More Info
Simon Anderson, MBBCh
Contact
[email protected]
Simon Anderson, MBBCh
Principal Investigator
Tacchini Hospital
Bento Gonçalves Rio Grande Do Sul, 95700, Brazil More Info
Magnus R Rodrigues
Contact
[email protected]
Magus R Rodrigues, MD
Principal Investigator
Hospital Beneficência Portuguesa
Bela Vista São Paulo, , Brazil More Info
Fernando Maluf, MD
Contact
[email protected]
Fernando Maluf, MD
Principal Investigator
Instituto do Câncer e Transplante
Curitiba , , Brazil More Info
Adriano Gonçalves e Silva, MD
Contact
[email protected]
Adriano Gonçalves e Silva, MD
Principal Investigator
Centro de Pesquisa em Oncologia
Porto Alegre , , Brazil More Info
Andre Fay
Contact
Andre Fay
Principal Investigator
Centro Paulista de Oncologia
São Paulo , , Brazil More Info
Andrey Soares, MD
Contact
[email protected]
Andrey Soares, MD
Principal Investigator
Instituto Câncer do Estado de São Paulo
São Paulo , , Brazil More Info
Diogo Bastos, MD
Contact
[email protected]
Diogo Bastos, MD
Principal Investigator
Cross Cancer Institute (Alberta Health Services)
Edmonton Alberta, T6G 1, Canada More Info
Michael Kolinsky, MD
Contact
[email protected]
Michael Kolinsky, MD
Principal Investigator
BC Cancer Agency
Vancouver British Columbia, , Canada More Info
Kim Chi
Contact
Kim Chi
Principal Investigator
Juravinski Cancer Centre
Hamilton Ontario, , Canada More Info
Sebastian Hotte
Contact
Sebastian Hotte
Principal Investigator
Ottawa Hospital Cancer Centre
Ottawa Ontario, , Canada More Info
Michael Ong
Contact
Michael Ong
Principal Investigator
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada More Info
Antonio Finelli, MD
Contact
[email protected]
Antonio Finelli, MD
Principal Investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Montréal Quebec, , Canada More Info
Fred Saad
Contact
Fred Saad
Principal Investigator
CHU de Québec-Université Laval
Québec Quebec, , Canada More Info
Frederic Pouliot
Contact
Frederic Pouliot
Principal Investigator
Beacon Hospital
Dublin Leinster, , Ireland More Info
Ray McDermott
Contact
Ray McDermott
Principal Investigator
Tallaght University Hospital
Dublin , D24 N, Ireland More Info
Ray McDermott, MD
Contact
[email protected]
Ray McDermott, MD
Principal Investigator
St. Vincent's University Hospital
Dublin , , Ireland More Info
Ray McDermott, MD
Contact
[email protected]
Ray McDermott, MD
Principal Investigator
Sligo University Hospital
Sligo , F91 H, Ireland More Info
Ala Yousif, MD
Contact
[email protected]
Ala Yousif, MD
Principal Investigator
The University of the West Indies - Mona Campus
Kingston , , Jamaica More Info
Simone Badal, PhD
Contact
[email protected]
Simone Badal, PhD
Principal Investigator
University of Nairobi
Nairobi , , Kenya More Info
Charles G Waihenya, MBChB
Contact
[email protected]
Charles G Waihenya, MBChB
Principal Investigator
Federal Medical Centre Abeokuta
Abeokuta , , Nigeria More Info
Ogo Ndukwe, MD
Contact
[email protected]
Ogo Ndukwe, MD
Principal Investigator
University of Ilorin Teaching Hospital
Ilorin , , Nigeria More Info
Ademola Popoola, MD
Contact
[email protected]
Ademola Popoola, MD
Principal Investigator
Lagos State University Teaching Hospital
Lagos , , Nigeria More Info
Fatiregun Omolara, MD
Contact
[email protected]
Fatiregun Omolara, MD
Principal Investigator
University of Maiduguri Teaching Hospital
Maiduguri , , Nigeria More Info
Dogo Hassan, MD
Contact
[email protected]
Dogo Hassan, MD
Principal Investigator
Oslo University Hospital
Oslo , 0379, Norway More Info
Kjell Russnes, MD
Contact
[email protected]
Kjell Russnes, MD
Principal Investigator
Vall d'Hebron Institute of Oncology
Barcelona Catalunya, , Spain More Info
Joaquin Mateo, MD
Contact
[email protected]
Joaquin Mateo, MD
Principal Investigator
Institut Catalá d'Oncologia Badalona
Badalona , , Spain More Info
Albert Font Pous, MD
Contact
[email protected]
Albert Font Pous, MD
Principal Investigator
Fundació Institut Mar d'Investigacions Mèdiques (Hospital del Mar).
Barcelona , , Spain More Info
Alejo Rodríguez Vida, MD
Contact
[email protected]
Alejo Rodríguez Vida, MD
Principal Investigator
Hospital Clínic de Barcelona
Barcelona , , Spain More Info
Antoni Vilaseca Cabo, MD
Contact
[email protected]
Antoni Vilaseca Cabo, MD
Principal Investigator
Hospital Provincial de Castellón
Castellón De La Plana , , Spain More Info
David Lorente, MD
Contact
[email protected]
David Lorente, MD
Principal Investigator
Hospital Universitario La Princesa
Madrid , 28006, Spain More Info
Nuria Romero, MD
Contact
[email protected]
Nuria Romero, MD
Principal Investigator
Hospital Clinico San Carlos
Madrid , , Spain More Info
Javier Puente, MD
Contact
[email protected]
Javier Puente, MD
Principal Investigator
Hospital Universitario 12 de Octubre
Madrid , , Spain More Info
Daniel Castellano, MD
Contact
[email protected]
Daniel Castellano, MD
Principal Investigator
Hospital Universitario Virgen de la Victoria
Málaga , , Spain More Info
Elena Castro, MD
Contact
[email protected]
Elena Castro, MD
Principal Investigator
Hospital Universitario Central de Asturias
Oviedo , 33011, Spain More Info
Emilio Esteban, MD
Contact
[email protected]
Emilio Esteban, MD
Principal Investigator
Instituto Valenciano de Oncología
Valencia , 46009, Spain More Info
Miguel Climent, MD
Contact
[email protected]
Miguel Climent, MD
Principal Investigator
Hospital Universitario Miguel Servet (Zaragoza)
Zaragoza , , Spain More Info
Angel Borque Fernando
Contact
[email protected]
Skane University Hospital
Malmö Skane, , Sweden More Info
Anders Bjartell
Contact
Anders Bjartell
Principal Investigator
Umea University Hospital
Umeå , 907 3, Sweden More Info
Camilla karlsson, MD
Contact
[email protected]
Camilla karlsson, MD
Principal Investigator
Orebro University Hospital
Örebro , , Sweden More Info
Janus Frey
Contact
[email protected];
Universitätsspital Basel
Basel , , Switzerland More Info
Cyrill Rentsch, MD, PhD
Contact
[email protected]
Cyrill Rentsch, MD, PhD
Principal Investigator
Ente Ospedaliero Cantonale
Bellinzona , 6500, Switzerland More Info
Ricardo Mestre, MD
Contact
Ricardo Mestre, MD
Principal Investigator
Kantonsspital Graubünden
Chur , , Switzerland More Info
Richard Cathomas
Contact
Richard Cathomas
Principal Investigator
Kantonsspital St. Gallen
Saint Gallen , , Switzerland More Info
Aurelius Omlin
Contact
Aurelius Omlin
Principal Investigator
Onkozentrum Zürich
Zürich , 8039, Switzerland More Info
Aurelius Omlin, M.D.
Contact
[email protected]
Aurelius Omlin, MD
Principal Investigator
Universitätsspital Zürich
Zürich , , Switzerland More Info
Thomas Hermanns, MD
Contact
[email protected]
Thomas Hermanns, MD
Principal Investigator
University Hospital Southampton NHS Foundation Trust
Southampton Hampshire, , United Kingdom More Info
Simon Crabb, MD
Contact
[email protected]
Simon Crabb, MD
Principal Investigator
Lister Hospital
Stevenage Hertfordshire, SG1 4, United Kingdom More Info
Anand Sharma, MD
Contact
[email protected]
Anand Sharma, MD
Principal Investigator
Mount Vernon Cancer Centre
Northwood Middlesex, HA6 2, United Kingdom More Info
Anand Sharma, MD
Contact
[email protected]
Anand Sharma, MD
Principal Investigator
Velindre Cancer Centre
Cardiff , , United Kingdom More Info
Jacob Tanguay, MD
Contact
[email protected]
Jacob Tanguay, MD
Principal Investigator
University Hospitals of Morecambe Bay NHS Foundation Trust
Lancaster , , United Kingdom More Info
Alison Birtle, MD
Contact
[email protected]
Alison Birtle, MD
Principal Investigator
Guys St Thomas NHS Foundation Trust
London , , United Kingdom More Info
Harriet Wylie
Contact
[email protected]
Deborah Enting
Principal Investigator
The Royal Marsden NHS Foundation Trust
London , , United Kingdom More Info
Vincent Khoo
Contact
[email protected]
Vincent Khoo, MD
Principal Investigator
The Christie NHS Foundation Trust
Manchester , , United Kingdom More Info
Ananya Choudhury
Contact
[email protected]
Lancashire Teaching Hospitals NHS Foundation Trust
Preston , PR2 9, United Kingdom More Info
Alison Birtle, MD
Contact
[email protected]
Alison Birtle, MD
Principal Investigator
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield , S10 2, United Kingdom More Info
Carmel Pezaro, MD
Contact
[email protected]
Carmel Pezaro, MD
Principal Investigator
South Tyneside District Hospital
South Shields , NE34 , United Kingdom More Info
Ashraf Azzabi, MD
Contact
[email protected]
Ashraf Azzabi, MD
Principal Investigator
Sunderland Royal Hospital
Sunderland , SR4 7, United Kingdom More Info
Ashraf Azzabi, MD
Contact
[email protected]
Ashraf Azzabi, MD
Principal Investigator
Clatterbridge Cancer Centre
Wirral , , United Kingdom More Info
Isabel Syndikus, MD
Contact
[email protected]
Isabel Syndikus, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

5000

Study ID:

NCT03151629

Recruitment Status:

Recruiting

Sponsor:


Prostate Cancer Clinical Trials Consortium

How clear is this clinincal trial information?

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