Study Stopped
DSMB
DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (AIPC Study of Calcitriol Enhancing Taxotere [ASCENT-2])
A Phase 3, Randomized, Open-Label Study Evaluating DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (ASCENT-2)
1 other identifier
interventional
1,200
9 countries
222
Brief Summary
The primary objective of this study is:
- To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on survival in metastatic androgen-independent prostate cancer The secondary objectives of this study are:
- To determine the effect of the ASCENT regimen on the rate of thromboembolic events (blood clots)
- To determine the effect of the ASCENT regimen on prevention of skeletal-related events (fractures)
- A Separate sub-study will be conducted at selected study sites in North America to determine the population PK of DN-101.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 prostate-cancer
Started Jan 2006
Shorter than P25 for phase_3 prostate-cancer
222 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2005
CompletedStudy Start
First participant enrolled
January 1, 2006
CompletedFirst Posted
Study publicly available on registry
January 9, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedNovember 6, 2007
November 1, 2007
December 14, 2005
November 2, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Histopathologically or cytologically proven adenocarcinoma of the prostate
- Documented metastatic prostate adenocarcinoma
- Documented progression while on androgen ablation therapy detected by rising prostate specific antigen (PSA) and/or imaging
- Age \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status \<= 2
- Adequate hematologic, renal and hepatic function
- Life expectancy \>= 3 months
You may not qualify if:
- Prior chemotherapy, except estramustine
- Prior chemotherapy with docetaxel
- Prior isotope therapy (e.g., strontium-89, samarium-153, etc.)
- One or more contraindications to the use of corticosteroids
- History of cancer-related hypercalcemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novacealead
Study Sites (222)
Birmingham Hematology & Oncology Associates, LLC
Birmingham, Alabama, 35223, United States
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, 35661, United States
Alaska Clinical Research Center
Anchorage, Alaska, 99508, United States
Hematology Associates - AOA
Phoenix, Arizona, 85012, United States
Premiere Oncology of Arizona
Scottsdale, Arizona, 85260, United States
Northern Arizona Hematology & Oncology Associates, AOA
Sedona, Arizona, 86336, United States
Southern Arizona VA Healthcare System
Tucson, Arizona, 85723, United States
U of Arizona / Arizona Cancer Center
Tucson, Arizona, 85724, United States
Genesis Cancer Center
Hot Springs, Arkansas, 71913, United States
Tower Cancer Research Foundation
Beverly Hills, California, 90211-1850, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
The Angeles Clinic and Research Institute, Inc.
Los Angeles, California, 90025, United States
UCLA department of Urology
Los Angeles, California, 90095-1738, United States
Veterans Affairs Northern California Health Care System
Martinez, California, 94553, United States
Sutter Gould Medical Foundation
Modesto, California, 95355, United States
Monterey Bay Oncology
Monterey, California, 93940, United States
Comprehensive Cancer Center at
Palm Springs, California, 92262, United States
Sutter Cancer Center
Sacramento, California, 95816, United States
UCD Cancer Center-Clinical Trials
Sacramento, California, 95817, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
Stanford University
Stanford, California, 94305, United States
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, 80909, United States
Georgetown University Lombardi Cancer Center
Washington D.C., District of Columbia, 20007, United States
Pasco Hernando Oncology Associates, P.A.
14529 Cortez Blvd., Florida, 34613, United States
North Broward Medical Center
Deerfield Beach, Florida, 33064, United States
Broward Oncology Associates
Fort Lauderdale, Florida, 33308, United States
Michael and Dianne Bienes Comprehensive Cancer Center
Fort Lauderdale, Florida, 33308, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Gainesville Hematology Oncology Associates
Gainesville, Florida, 32605, United States
University of Florida Shands Cancer Center
Gainesville, Florida, 32611, United States
Integrated Community Oncology Network
Jacksonville, Florida, 32256, United States
Sylvester Comprehensive Cancer Center, U of Miami
Miami, Florida, 33136, United States
Pasco Hernando Oncology Associates P.A.
New Port Richey, Florida, 34652, United States
Florida Cancer Institute
New Port Richey, Florida, 34655, United States
Innovative Medical Research of South Florida Inc.
North Miami Beach, Florida, 33179, United States
Ocala Oncology Center
Ocala, Florida, 34474, United States
Cancer Centers of Florida, P.A.
Ocoee, Florida, 34761, United States
AYS Urology
Trinity, Florida, 34655, United States
Phoebe Cancer Center
Albany, Georgia, 31701, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, 30607, United States
Peachtree Hematology-Oncology Consultants, PC
Atlanta, Georgia, 30309, United States
Atlanta Cancer Care
Atlanta, Georgia, 30342, United States
Northeast GA Medical Center
Gainesville, Georgia, 30501, United States
Georgia Cancer Specialist
Tucker, Georgia, 30084, United States
South Georgia Medical Center
Valdosta, Georgia, 31602, United States
Hematology Oncology Associates of Illinois
Chicago, Illinois, 60611, United States
Midwest Prostate & Urology Health Center
Chicago, Illinois, 60640, United States
Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, 60714, United States
Oncology Specialists
Park Ridge, Illinois, 60068, United States
Swedish American Regional Cancer Center
Rockford, Illinois, 61104, United States
Hematology Oncology Associates of Illinois, L.L.C
Skokie, Illinois, 60077, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, 46227, United States
Medical Consultants, PC c/o Ball Cancer Center
Muncie, Indiana, 47303, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601, United States
Hope Center
Terre Haute, Indiana, 47802, United States
Medical Center of Vincennes
Vincennes, Indiana, 47591, United States
Iowa Cancer Care
Cedar Rapids, Iowa, 52403, United States
Mercy Medical Center, North Iowa
Mason City, Iowa, 50401, United States
Siouxland Hematology-Oncology Associates
Sioux City, Iowa, 51101, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Hematology Oncology Life Center
Alexandria, Louisiana, 71301, United States
Maine Center for Cancer Medicine & Blood Disorders
Scarborough, Maine, 04074, United States
St. Agnes Health System
Baltimore, Maryland, 21229, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, 21044, United States
Frederick Memorial Hospital
Frederick, Maryland, 21701, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404, United States
MN Cooperative Group Outreach Prg.
Minneapolis, Minnesota, 55407, United States
Park Nicollet Institute
Saint Louis Park, Minnesota, 55416, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
University of Missouri, Ellis Fischel Cancer Center
Columbia, Missouri, 65203, United States
St. Joseph Oncology, Inc.
Saint Joseph, Missouri, 64507, United States
Nebraska Hematology-Oncology, PC
Lincoln, Nebraska, 68506, United States
Nebraska Methodist Hospital - Oncology Research Dept
Omaha, Nebraska, 68144, United States
Horizon's West Medical Group
Scottsbluff, Nebraska, 69361, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89109, United States
Nevada Cancer Institute
Las Vegas, Nevada, 89135, United States
UMDNJ-Newark
Newark, New Jersey, 07101, United States
The Valley Hospital
Paramus, New Jersey, 07652, United States
Overlook Oncology Center
Summit, New Jersey, 07901, United States
New Mexico Cancer Care Associates
Sante Fe, New Mexico, 87505, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
Hematology Oncology Associates of
New City, New York, 10956, United States
Memorial Sloan-Kett
New York, New York, 10021, United States
Interlakes Foundation Inc.
Rochester, New York, 14623, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Staten Island Urological Research, PC
Staten Island, New York, 10304, United States
Raleigh Hematology Oncology Associates
Cary, North Carolina, 27511, United States
Carolina Cancer Management, Inc.
Fayetteville, North Carolina, 28304, United States
Piedmont Hematology Oncology Associates, PLLC
Winston-Salem, North Carolina, 27103, United States
Dakota Cancer Institute
Fargo, North Dakota, 58103, United States
Aultman Hospital
Canton, Ohio, 44710, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Mid Ohio Oncology/Hematology, Inc.
Columbus, Ohio, 43213, United States
Dayton Oncology & Hematology, P.A.
Kettering, Ohio, 45409, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Cancer Care Associates
Oklahoma City, Oklahoma, 73112, United States
Cancer Care Associates
Tulsa, Oklahoma, 74136, United States
Willamette Valley Cancer Center
Eugene, Oregon, 97401-8122, United States
Consultants in Medical Oncology & Hematology
Drexel Hill, Pennsylvania, 19026, United States
Hematology & Oncology Associates of Northeastern PA
Dunmore, Pennsylvania, 18512, United States
Medical Oncology Associates of Wyoming Valley, PC
Kingston, Pennsylvania, 18704, United States
St. Mary Medical Center
Langhorne, Pennsylvania, 19047, United States
Greater Philadelphia Cancer
Philadelphia, Pennsylvania, 19114, United States
Univeristy of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232, United States
Pottsville Cancer Care
Pottsville, Pennsylvania, 17901, United States
Guthrie Clinic
Sayre, Pennsylvania, 18840, United States
Charleston Hematology Oncology PA
Charleston, South Carolina, 29403, United States
Charleston Cancer Center
Charleston, South Carolina, 29406, United States
Medical University Of South Carolina
Charleston, South Carolina, 29425, United States
Cancer Centers of the Carolina
Greenville, South Carolina, 29615, United States
South Carolina Cancer Specialists
Hilton Head Island, South Carolina, 29926, United States
Chattanooga Oncology & Hematology Assoc.
Chattanooga, Tennessee, TN, United States
The Jones Clinic
Germantown, Tennessee, 38138, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Texas Cancer Center-Abilene
Abilene, Texas, 79606-5208, United States
Texas Oncology, PA
Amarillo, Texas, 79106, United States
Texas Cancer Center
Arlington, Texas, 76014, United States
Urology Associates of North Texas (UANT)
Arlington, Texas, 76017, United States
Texas Oncology Cancer Center
Austin, Texas, 78731, United States
MamieMcFaddin Ward Cancer Center
Beaumont, Texas, 77702-1449, United States
Texas Cancer Center ar Medical City
Dallas, Texas, 75230-2510, United States
Center for Oncology Research and Treatment, PA
Dallas, Texas, 75230, United States
Texas Oncology, P.A.
Dallas, Texas, 75231-4400, United States
The Texas Cancer Center
Dallas, Texas, 75237, United States
El Paso Cancer Treatment Center-East
El Paso, Texas, 79915, United States
Texas Oncology, P.A.
Fort Worth, Texas, 76104, United States
The Center for Cancer & Blood Disorders
Fort Worth, Texas, 76104, United States
Texas Oncology, P.A.
Garland, Texas, 75042-5788, United States
Texas Oncology, P.A.
Houston, Texas, 77024, United States
Lake Vista Cancer Center
Lewisville, Texas, 75067, United States
Texas Oncology, P.A.
Longview, Texas, 75601, United States
Southwest Cancer Treatment and Research Center
Lubbock, Texas, 79415, United States
South Texas Cancer Center - McAllen
McAllen, Texas, 78503, United States
Texas Cancer Center of Mesquite
Mesquite, Texas, 75150, United States
Allison Cancer Center
Midland, Texas, 79701-5946, United States
Cancer Care Network of South Texas, HOAST
New Braunfels, Texas, 78131, United States
West Texas Cancer Center
Odessa, Texas, 79761, United States
Paris Regional Cancer Center
Paris, Texas, 75460-5004, United States
South Texas Oncology and Hematology, PA
San Antonio, Texas, 78229, United States
InVisions Consultants LLC
San Antonio, Texas, 78233, United States
Texas Cancer Center- Sherman
Sherman, Texas, 75090-0504, United States
Texas Oncology Cancer Center-Sugar Land
Sugar Land, Texas, 77479, United States
Texas Oncology
Waco, Texas, 76022, United States
Texas Oncology Cancer Care and Research Center
Waco, Texas, 76712, United States
Fairfax Northern Virginia Hematology OnCology, PC
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.
Salem, Virginia, 24153, United States
Highline Medical Oncology
Burien, Washington, 98166, United States
Puget Sound Cancer Centers
Edmonds, Washington, 98026, United States
University of Washington
Seattle, Washington, 98109, United States
Puget Sound Cancer Centers
Seattle, Washington, 98133, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Tom Baker Cancer Center-Medical Oncology
Calgary, Alberta, T2N4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
BCCA-Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
BCCA-Vancouver
Vancouver, British Columbia, V5Z4E6, Canada
British Columbia Cancer Agency - Vancouver Island Centre
Victoria, British Columbia, V8R 6V5, Canada
Cancer Care Manitoba
Winnipeg, Manitoba, R3E0V9, Canada
The Moncton Hospital (SERHA)
Moncton, New Brunswick, E1C 6Z8, Canada
Dr. Leon Richard Oncology Center
Moncton, New Brunswick, EIC8X3, Canada
Centre for Clinical Research Cancer Care Program
Halifax, Nova Scotia, B3H 1V7, Canada
Regional Cancer Program de l'Hopital Regional de Sudbury
Greater Sudbury, Ontario, P3E 5J1, Canada
Jaravinski Cancer Centre Hamilton Health Services
Hamilton, Ontario, L8V 5C2, Canada
Cancer Centre of Southeastern Ontario
Kingston, Ontario, K7L 5P9, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3, Canada
McGill University
Montreal, Quebec, H2W 1S6, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Institute of Radiation Oncology of Teaching Hospital Na Bulovce
Prague, 180 81, Czechia
Department of Radiation and Oncology of Teaching Hospital Motol
Prague, Czechia
Teaching Hospital Kralovske Vinohrady
Prague, Czechia
Universitätsklinikum Köln
Cologne, 50931, Germany
Gemeinschaftspraxis für Hämatologie & Onkologie
Augsburg, 86150, Germany
Facharzt f. Urologie
Bad Schwartau, 23611, Germany
Urologische Praxis
Bautzen, 02625, Germany
Universitatsmedizin Charité
Berlin, 10117, Germany
Klinik am Urban
Berlin, 10967, Germany
Universitätsmedizin Charité Campus Benjamin Franklin
Berlin, 12200, Germany
Urologische Praxis
Berlin, Germany
Städtisches Klinikum Braunschweig
Braunschweig, 38126, Germany
Facharzt f. Urologie
Cottbus, 03046, Germany
Urologische Klinik
Dresden, 01307, Germany
Universitäsklinikum Düsseldorf
Düsseldorf, 40225, Germany
Urologische Klinik der Universitätsklink Düsseldorf
Düsseldorf, 40225, Germany
Universitätsklinikum Essen
Essen, Germany
Klinikum Fulda, Urologische Klinik
Fulda, 36043, Germany
Urologische Praxis
Hagenow, Germany
Urologische Gemeinschaftspraxis
Hamburg, 22399, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Nationales Centrum für Tumorerkrankungen
Heidelberg, 69120, Germany
Universitätsklinikum Homburg/Saar
Homburg, Germany
Klinikum Kassel GmbH
Kassel, 34125, Germany
Gemeinschaftspraxis für Urologie
Kirchheim/Teck, 73230, Germany
Gesellschaft f. klinische Studien und Urologisches Gesundheitszentrum
Leipzig, Germany
Oberarzt d. Urolog. Abteilung
München, 81675, Germany
Obearzt der Urologischen Klinik, Universitätsklinik Münster
Münster, 48149, Germany
Praxisgemeinschaft für Onkologie und Urologie
Wilhelmshaven, 26389, Germany
Gemeinschaftspraxis f. Urologie
Wuppertal, 42103, Germany
Urologische Praxis
Zwickau, Germany
IRM Center Hospital and Institutes, II.Department of Oncology
Budapest, 1071, Hungary
Uzsoki Hospital of the Local Authority of Budapest, Oncoradiology
Budapest, H-1145, Hungary
University of Debrecen, Medical and Health Science Center, Department of Oncology
Debrecen, H4032, Hungary
University of Szeged, Szent-Györgyi Albert Medical and Pharmacist Science Center, Clinic of Oncotherapy
Szeged, Hungary
San Juan VA Medical Center, Reseach Dept
San Juan, 00921, Puerto Rico
Cabinetul de Urologie
Arad, 310175, Romania
Policlinica de diagnostic rapid
Brasov, 500366, Romania
Institutul Oncologic Bucuresti
Bucharest, Romania
Euro S.R.L.
Cluj-Napoca, 400046, Romania
ProVita 2000
Constanța, 900635, Romania
Clinical Center Niš - Clinic of Urology
Belgrade, 18000, Serbia and Montenegro
Theaching Hospital of F.D. Roosevelt
Banská Bystrica, 97517, Slovakia
Faculty Hospital Martin
Martin, 03659, Slovakia
Faculty Hospital of J. A. Reiman
Prešov, Slovakia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Howard I. Scher, MD
Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan Kettering Cancer Center
- STUDY CHAIR
Kim N. Chi, M.D.
British Columbia Cancer Agency - Vancouver Centre
- STUDY CHAIR
Ronald De-Wit, M.D.
Erasmus University Medical Center (Netherlands)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 14, 2005
First Posted
January 9, 2006
Study Start
January 1, 2006
Study Completion
November 1, 2007
Last Updated
November 6, 2007
Record last verified: 2007-11