Prostatic Neoplasms Clinical Trial
Official title:
A Phase III, Randomized Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer
| NCT number | NCT00036556 |
| Other study ID # | M00-244 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | May 10, 2002 |
| Last updated | August 13, 2007 |
| Start date | June 2001 |
| Verified date | August 2007 |
| Source | Abbott |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This study is being done to evaluate the safety and efficacy of atrasentan in men with non-metastatic hormone-refractory prostate cancer.
| Status | Completed |
| Enrollment | 941 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 19 Years and older |
| Eligibility |
Inclusion Criteria: - Have been diagnosed with prostate cancer. - Have a rising PSA while on hormone therapy or following surgical castration. Exclusion Criteria: - Have evidence of distant metastatic disease on screening bone scan or CT scan. - Have received cytotoxic chemotherapy. - Have received opioid or narcotic medications (such as codeine or morphine) or radiation for pain caused by your prostate cancer in the last 6 months. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Repatriation General Hospital | Daws Park | South Australia |
| Australia | Peter Maccallum Cancer Institute | East Melbourne | Victoria |
| Australia | Royal Brisbane Hospital | Herston | Queensland |
| Australia | Bayside Urology | Mentone | Victoria |
| Australia | Royal Melbourne Hospital | Parkville | Victoria |
| Australia | Prince Of Wales Hospital | Randwick | New South Wales |
| Australia | Westmead Public Hospital | Westmead | New South Wales |
| Australia | Princess Alexandra Hospital | Woolloongabba | |
| Austria | A. Ö. Krankenhaus Mistelbach | Mistelbach | |
| Austria | Klinik fur Urologie der Universitat Wien | Wien | |
| Belgium | A.Z. Middelheim | Antwerpen | |
| Belgium | A Z St Jan | Brugge | |
| Belgium | University Hospital Erasme | Bruxelles | |
| Belgium | Uz Gent | Gent | |
| Belgium | Private Practice Dr.Vekemans | Hasselt | |
| Belgium | C.H.U. Liege | Liege | |
| Belgium | St-Elisabeth Ziekenhuis | Turnhout | |
| Canada | The Male Health Centres | Barrie | Ontario |
| Canada | The Urology Resource Centre | Burlington | Ontario |
| Canada | Tom Baker Cancer Center | Calgary, | Alberta |
| Canada | Cross Cancer Institute | Edmonton, | Alberta |
| Canada | Service Radio-Oncologie, Chus | Fleurimont, | Quebec |
| Canada | Professional Corporation | Fredericton | New Brunswick |
| Canada | Queen Elizabeth II Health Sciences Center | Halifax | Nova Scotia |
| Canada | Hamilton & District Urology Association | Hamilton, | Ontario |
| Canada | Wilson Urology | Kelowna | British Columbia |
| Canada | Valley Professional Centre | Kentville | Nova Scotia |
| Canada | Kingston General Hospital | Kingston | Ontario |
| Canada | Probidity Medical Research | Kitchener | Ontario |
| Canada | London Health Sciences Centre | London | Ontario |
| Canada | Quest Clinical Trials | Markham | Ontario |
| Canada | Hopital Notre-Dame | Montreal | Quebec |
| Canada | Royal Victoria Hospital | Montreal | Quebec |
| Canada | Walk-In Clinic | North Bay | Ontario |
| Canada | Jack Barkin, M.D. | North York | Ontario |
| Canada | The Male Health Centres | Oakville | Ontario |
| Canada | Ottawa Hospital Civic Campus | Ottawa | Ontario |
| Canada | Ultramed | Pointe Claire | Quebec |
| Canada | Chuq Pavillon Hotel-Dieu | Quebec | |
| Canada | Peter Lau, MD | Saskatoon, | Saskatchewan |
| Canada | Advanced Male Fertility Clinic | Scarborough, | Ontario |
| Canada | Northeastern Ontario Regional Cancer Centre | Sudbury, | Ontario |
| Canada | Dr. Cal Andreou | Surrey | British Columbia |
| Canada | Princess Margaret Hospital | Toronto | Ontario |
| Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
| Canada | Vancouver Hospital & Health Sciences Centre | Vancouver | British Columbia |
| Canada | Dr. Gary Steinhoff, Clinical Research | Victoria | British Columbia |
| Canada | Dr. P. J. Pommerville, Inc. | Victoria | British Columbia |
| Canada | Abbott Clinic | Winnipeg | Manitoba |
| France | Hôpital D´Auxerre | Auxerre | |
| France | Hôpital Henri Mondor | Creteil | |
| France | Hopital Intercommunal | Creteil | Cedex |
| France | Hôpital Salvator | Marseille | Cedex |
| France | Hôpital Pasteur | Nice | Cedex |
| France | Hopital Bichat Claude Bernard | Paris | |
| France | Hôpital Cochin | Paris | Cedex 14 |
| France | Hôpital Saint Louis | Paris | Cedex |
| France | Centre Hospitalier Rene Dubos | Pontoise | Cedex |
| France | Hopital De Pontchaillou | Rennes | Cedex |
| France | Hopital De Rangueil | Toulouse | Cedex |
| Germany | Allgemeines Krankenhaus Urologie | Celle | |
| Germany | Universitätsklinikum Urologie | Essen | |
| Germany | Universitätsklinkum | Freiburg | |
| Germany | Allgemeines Krankenhaus Barmbek | Hamburg | |
| Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg | |
| Germany | Klinik Und Poliklinik für Urologie und Kinder | Homburg / Saar | |
| Germany | Universitätsklinikum Lübeck Urologie | Lübeck | |
| Germany | Universitätsklinikum Mannheim | Mannheim | |
| Germany | Klinikum Rechts Der Isar | Munchen | |
| Germany | Urologische Klinik Und Poliklinik Grosshadern | Munchen | |
| Germany | Universitat Ulm | ULM | |
| Germany | Klinikum Wuppertal GmbH | Wuppertal | |
| Greece | 'Alexandra' Hospital | Athens | |
| Greece | Pe.Pa.G.N.I Hospital | Heraklion | |
| Greece | G. Genimatas Hospital | Thessaloniki | |
| Ireland | Mater Misericordiae Hospital | Dublin | |
| Ireland | St Vincent'S Hospital | Dublin | |
| Ireland | Tallaght Hospital | Dublin | |
| Italy | Clinica Urologica I - Università di Bari | Bari | |
| Italy | Istituto Nazionale per la Ricerca sul Cancro -IST | Genoa | |
| Italy | Clinica Urologica - Università Di Milano | Milan | |
| Italy | Istituto Europeo di Oncologia | Milan | |
| Italy | Istituto di Urologia | Padova | |
| Italy | Policlinico G. B. Rossi | Verona | |
| Netherlands | Amc | Amsterdam | |
| Netherlands | Rijnstate Hospital | Arnhem | |
| Netherlands | Medisch Spectrun Twente | Enschede | |
| Netherlands | Atrium Heerlen | Heerlen | |
| Netherlands | St Franciscus Gasthuis | Rotterdam | |
| Netherlands | University Hospital Rotterdam | Rotterdam | |
| New Zealand | Canterbury Urology Research Trust | Christchurch | |
| New Zealand | Promed Urology Ltd. | Tauranga | |
| Poland | Samodzielny Publiczny ZOZ | Bydgoszcz | |
| Poland | Katedra i Klinika Urologii - Akademia Medyczna w Gdansku | Gdansk | |
| Poland | Specjalistyczny Szpital Urologiczny | Katowice | |
| Poland | Instytut im. Marii Sklodowskiej-Curie | Warszawa | |
| Poland | Szpital Kliniczny Dzieciatka Jezus | Warszawa | |
| Poland | Akademia Medyczna we Wroclawiu | Wroclaw | |
| South Africa | University Of Stellenbosch | Cape Town | |
| South Africa | University Of Natal - Nelson R Mandela School of Medicine | Durban | |
| South Africa | Kenridge St Joseph Wingl | Parktown | |
| South Africa | Mediclinic Hospital | Petermaritzburg | 3201 |
| South Africa | Medi-Clinic Hospital | Pietermaritzburg | |
| South Africa | Medical Centre | Pietermaritzburg | |
| South Africa | Pretoria Urology Hospital | Pretoria | |
| Spain | Hospital de la Ribera | Alcira (Valencia) | |
| Spain | Hospital Vall D'Hebron | Barcelona | |
| Spain | Hospital de Galdakao | Galdakao-Vizcaya | |
| Spain | Hospital Juan Canalejo | La Coruna | |
| Spain | Clinica Puerta De Hierro | Madrid | |
| Spain | Hospital 12 De Octubre | Madrid | |
| Spain | Hospital Carlos Haya | Malaga | |
| Spain | Hospital Marques De Valdecilla | Santander | |
| Spain | Instituto Valenciano De Oncologia | Valencia | |
| Sweden | Sahlgrenska University Hospital | Gothenburg | |
| Sweden | Linkoping University Hospital | Linkoping | |
| Sweden | Lund University Hospital | Lund | |
| Sweden | Malmo University Hospital MAS | Malmo | |
| Sweden | Karolinska Hospital | Stockholm | |
| Sweden | Uppsala University Hospital | Uppsala | |
| United Kingdom | Clatterbridge Centre For Oncology | Bebington | Wirral |
| United Kingdom | St Lukes Hospital | Bradford | West Yorkshire |
| United Kingdom | Southmead Hospital | Bristol | |
| United Kingdom | Addenbrookes Hospital | Cambridge | |
| United Kingdom | St Richard'S Hospital | Chichester | |
| United Kingdom | Leighton Hospital | Crewe | |
| United Kingdom | Western General Hospital | Edinburgh, | Scotland |
| United Kingdom | Royal Devon And Exeter Hospital | Exeter, | Devon |
| United Kingdom | Gartnavel General Hospital | Glasgow | |
| United Kingdom | Glasgow Royal Infirmary | Glasgow | |
| United Kingdom | Northwick Park Hospital | Harrow | Middlesex |
| United Kingdom | Clinical Research Centre - St Georges Hospital | London | |
| United Kingdom | Royal Free Hospital | London | |
| United Kingdom | St Batholomew'S Hospital | London | |
| United Kingdom | Hope Hospital | Salford | |
| United Kingdom | Royal Hallamshire Hospital | Sheffield | |
| United Kingdom | Southampton General | Southampton | |
| United Kingdom | Lister Hospital | Stevenage | Hertfordshire |
| United Kingdom | The Institute Of Cancer Research - Royal Marsden Hospital | Sutton | Surrey |
| United Kingdom | Taunton And Somerset Hospital | Taunton | Somerset |
| United States | Albany Medical Center South Clinical Campus | Albany | New York |
| United States | UNM Medical Center | Albuquerque | New Mexico |
| United States | Urologic Associates of Allentown | Allentown | Pennsylvania |
| United States | Alaska Clinical Research Center, LLC | Anchorage | Alaska |
| United States | Emory Clinic | Atlanta | Georgia |
| United States | Peachtree Hematology/Oncology Consultants | Atlanta | Georgia |
| United States | Sandy Springs Urology | Atlanta | Georgia |
| United States | Dreyer Medical Clinic | Aurora | Illinois |
| United States | South Fl Medical Research | Aventura | Florida |
| United States | Johns Hopkins Oncology Center | Baltimore | Maryland |
| United States | Billings Oncology Associates | Billings, | Montana |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | HemOnCare, PC | Brooklyn | New York |
| United States | University Of Vermont | Burlington, | Vermont |
| United States | The University Of North Carolina At Chapel Hill | Chapel Hill | North Carolina |
| United States | Blumenthal Cancer Center | Charlotte | North Carolina |
| United States | Mckay Urology | Charlotte, | North Carolina |
| United States | Urology Specialists Of The Carolinas | Charlotte, | North Carolina |
| United States | Wyoming Research Foundation | Cheyenne | Wyoming |
| United States | Christopher Ryan, MD | Chicago | Illinois |
| United States | Northwestern University Medical School | Chicago | Illinois |
| United States | Progressive Care, S.C. | Chicago | Illinois |
| United States | Weiss Memorial Hospital | Chicago, | Illinois |
| United States | Robin V. Smith, MD | Chula Vista | California |
| United States | University Of Cincinnati Medical Center | Cincinnati, | Ohio |
| United States | Dept of Veteran's Affairs North Texas Healthcare System | Dallas | Texas |
| United States | Ntouch Research Corporation | Dallas | Texas |
| United States | The University Of TX SW Medical Center At Dallas | Dallas | Texas |
| United States | Urologic Associates, Pc | Davenport | Iowa |
| United States | Atlanta Va Medical Center | Decatur | Georgia |
| United States | Urology Associate, Pc | Denver, | Colorado |
| United States | Iowa Urology | Des Moines | Iowa |
| United States | Oregon Urology Specialists | Eugene | Oregon |
| United States | Evanston Hospital Kellogg Cancer Center | Evanston | Illinois |
| United States | Welborn Clinic | Evansville | Indiana |
| United States | Welborn Clinic -East | Evansville | Indiana |
| United States | Clinical Physiology Associates | Fort Myers | Florida |
| United States | Urology Associate Of Central California | Fresno, | California |
| United States | South Valley Medical Plaza | Gilroy | California |
| United States | Michigan Medical Urology | Grand Rapids | Michigan |
| United States | Drs. Werner, Murdock, & Francis, Pa Urology Assoc. | Greenbelt | Maryland |
| United States | The Urology Center | Greensboro, | North Carolina |
| United States | The Medical Oncology Group | Gulfport, | Mississippi |
| United States | Milton S. Hershey Medical Center | Hershey | Pennsylvania |
| United States | Urology Centers Of Alabama | Homewood, | Alabama |
| United States | Mississippi Center For Clinical Research, LLC | Jackson | Mississippi |
| United States | Kansas University Medical Center | Kansas City, | Kansas |
| United States | San Diego Urology Center | La Mesa | California |
| United States | South Orange County Medical Research Center | Laguna Hills | California |
| United States | Urological Associates Of Lancaster | Lancaster | Pennsylvania |
| United States | Arkansas Urologial Associates, PA | Little Rock | Arkansas |
| United States | UCLA School of Medicine | Los Angeles | California |
| United States | University of TN - Memphis | Memphis | Tennessee |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | Midwest Research Specialists, LLC | Milwaukee | Wisconsin |
| United States | Urology Associates | Nashville | Tennessee |
| United States | Vanderbilt University Medical Center | Nashville, | Tennessee |
| United States | Advanced Research Institute | New Port Richey | Florida |
| United States | Beth Israel Medical Center | New York | New York |
| United States | NYU Medical Center | New York | New York |
| United States | Nyack Hospital | Nyack | New York |
| United States | University of Nebraska Medical Center | Omaha, | Nebraska |
| United States | VA Palo Alto | Palo Alto | California |
| United States | Albert Einstein Medical Center | Philadelphia | Pennsylvania |
| United States | University Of Pittsburgh | Pittsburgh | Pennsylvania |
| United States | Multimed Research | Providence, | Rhode Island |
| United States | Nevada Urology Associate | Reno | Nevada |
| United States | Virginia Urology Center | Richmond, | Virginia |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Mid Atlantic Clinical Research | Rockville | Maryland |
| United States | Western Urological Clinic | Salt Lake City | Utah |
| United States | Anthony Middleton, M.D. | Salt Lake City, | Utah |
| United States | Uthscsa | San Antonio | Texas |
| United States | Hillcrest Urological Medical Group, Inc. | San Diego | California |
| United States | Urology Associates Of San Luis Obispo | San Luis Obispo, | California |
| United States | Pacific Clinical Research | Santa Monica | California |
| United States | Dattoli Cancer Center | Sarasota, | Florida |
| United States | Urology Treatment Center | Sarasota, | Florida |
| United States | Seattle Urological Associates | Seattle | Washington |
| United States | University Of Washington School Of Medicine | Seattle | Washington |
| United States | Jeffrey Frankel, M.D. | Seattle, | Washington |
| United States | LSUHSC | Shreveport | Louisiana |
| United States | Regional Urology | Shreveport | Louisiana |
| United States | Michigan Institute Of Urology, Pc | St. Clair Shores | Michigan |
| United States | Lakeside Urology, PC | St. Joseph | Michigan |
| United States | St. Joseph Oncology | St. Joseph | Missouri |
| United States | Washington University | St. Louis | Missouri |
| United States | Madigan Army Medical Center | Tacoma, | Washington |
| United States | Southeastern Urological Center, P.A. | Tallahassee | Florida |
| United States | Scott & White Memorial Hospital | Temple, | Texas |
| United States | Western Clinical Research, Inc. | Torrance, | California |
| United States | Advanced Clinical Trials | Tucson | Arizona |
| United States | Urologic Specialists Of Oklahoma, Inc. | Tulsa, | Oklahoma |
| United States | Center for Urologic Care | West Reading, | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott |
United States, Australia, Austria, Belgium, Canada, France, Germany, Greece, Ireland, Italy, Netherlands, New Zealand, Poland, South Africa, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time-to-disease progression will be determined by the time to onset of the earliest of one of the following events: New skeletal lesions, new metastatic extra-skeletal lesions, or an event due to metastatic prostate cancer. | Every 12 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04964271 -
Identification of Prostate Cancer Specific Markers in Patients Compared to Healthy Participants
|
||
| Completed |
NCT02546908 -
A Registry of Participants With Prostate Cancer in Asia
|
||
| Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
| Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
| Completed |
NCT01683994 -
Cabozantinib Plus Docetaxel and Prednisone for Advanced Prostate Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT04838613 -
Study of Diagnostic Performance of [18F]CTT1057 in BCR
|
Phase 3 | |
| Completed |
NCT02364531 -
A Canadian Observational Study in Metastatic Cancer of the Prostate: A Study of ZYTIGA Use in the Community Urology Setting
|
||
| Completed |
NCT01929655 -
Japanese BAY88-8223 Monotherapy Phase II Study
|
Phase 2 | |
| Active, not recruiting |
NCT05022849 -
A Study of JNJ-75229414 for Metastatic Castration-resistant Prostate Cancer Participants
|
Phase 1 | |
| Completed |
NCT03261999 -
Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer
|
Phase 3 | |
| Terminated |
NCT04907227 -
Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)-China Extension
|
Phase 3 | |
| Active, not recruiting |
NCT03587285 -
A Pilot Study of Hormonal Therapy Combined With Central Memory T Cells (Tcm) for Patients With Advanced Prostate Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT02217566 -
Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy
|
Phase 2 | |
| Not yet recruiting |
NCT04101305 -
Measurement of Circulating Tumor Cells in Prostate Cancer
|
||
| Active, not recruiting |
NCT02950064 -
A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations
|
Phase 1 | |
| Terminated |
NCT03066154 -
Oral Docetaxel (ModraDoc/r) in Combination With Hormonal Treatment and Radiation Therapy in High-risk Prostate Cancer
|
Phase 1 | |
| Withdrawn |
NCT02905201 -
A Prospective Compliance Registry for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
|
N/A | |
| Completed |
NCT02692976 -
Natural Dendritic Cells for Immunotherapy of Chemo-naive Metastatic Castration-resistant Prostate Cancer Patients
|
Phase 2 | |
| Terminated |
NCT01420965 -
Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer
|
Phase 2 | |
| Completed |
NCT01441713 -
Treatment Frequency and Satisfaction in Patients With Advanced Prostate Cancer
|
N/A |