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Brief Title: Efficacy Study of ABR-215050 to Treat Prostate Cancer
Official Title: Phase II Randomized Double Blind Placebo-Controlled Study to Determine the Efficacy of ABR-215050 in Asymptomatic Patients With Metastatic Castrate-Resistant Prostate Cancer
Study ID: NCT00560482
Brief Summary: To investigate ABR-215050 as a possible treatment for prostate cancer.
Detailed Description: For asymptomatic patients with Castrate-Resistant Prostate Cancer (CRPC), a "window of opportunity" is present. During this "window of opportunity" an intervention with little or no toxicity and the potential for extending the "symptom-free" period would be of great value to keep metastatic patients in an asymptomatic stage and thus delay the introduction of chemotherapy. The purpose of this study is to evaluate the safety and efficacy of ABR-215050 as an interventional agent for this role. Overall survival for patients participating in study 07TASQ08 will be evaluated retrospectively using a separate study protocol 11TASQ11.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Alaska Clinical Research Center LLC, Anchorage, Alaska, United States
Southern California Permanente Medical Group, Anaheim, California, United States
Southern California Permanente Medical Group, Baldwin Park, California, United States
Southern California Permanente Medical Group, Bellflower, California, United States
Pacific Clinical Center, Beverly Hills, California, United States
South County Hematology/Oncology, Chula Vista, California, United States
Southern California Permanente Medical Group, Fontana, California, United States
Southern California Permanente Medical Group, Irvine, California, United States
Cancer Center Oncology Medical Group, La Mesa, California, United States
North County Oncology Medical Clinic, Inc., Oceanside, California, United States
San Bernardino Urological Associates, San Bernardino, California, United States
Urological Physicians of San Diego, Inc., San Diego, California, United States
Southern California Permanente Medical Group, San Diego, California, United States
Medical Oncology Associates - SD, San Diego, California, United States
Sharp Memorial Hospital Investigational Pharmacy, San Diego, California, United States
Sharp Rees-Stealy, San Diego, California, United States
Pacific Clinical Research, Santa Monica, California, United States
Agajanian Institute of Oncology and Hematology, Whittier, California, United States
Porter Adventist Hospital, Denver, Colorado, United States
Urology Associates, PC, Denver, Colorado, United States
Diagnostic Professionals, Inc, Plantation, Florida, United States
Southeastern Resarch Group, Inc., Tallahassee, Florida, United States
Peachtree Hematology-Oncology Consultants, Atlanta, Georgia, United States
St. Alphonsus Regional Medical Center, Boise, Idaho, United States
North Idaho Urology, Coeur d'Alene, Idaho, United States
Idaho Urologic Institute, PA, Meridian, Idaho, United States
North Idaho Urology, Sandpoint, Idaho, United States
University of Chicago, Chicago, Illinois, United States
Evanston Northwestern Healthcare, Evanston, Illinois, United States
Galesburg Cottage Hospital, Galesburg, Illinois, United States
Medical and Surgical Specialists, Galesburg, Illinois, United States
OSF St Mary Medical Center, Galesburg, Illinois, United States
Midwest Urology/RMD Clinical Research Institute, Melrose Park, Illinois, United States
Johns Hopkins, Baltimore, Maryland, United States
AdvanceMed Research, Lawrenceville, New Jersey, United States
Urology Group of New Mexico, Albuquerque, New Mexico, United States
Community Care Physicians, PC / The Urological Institute of Northeastern New York, Albany, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Beth Israel Medical Center, New York, New York, United States
University Urological Associates, New York, New York, United States
Staten Island Urological Research, PC, Staten Island, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Urological Associates, Raleigh, North Carolina, United States
Urologic Consultants of SE PA, Bala Cynwyd, Pennsylvania, United States
Center for Urologic Care of the Main Line, Bryn Mawr, Pennsylvania, United States
Urological Associates of Lancaster, Lancaster, Pennsylvania, United States
University of Pittsburgh Physicians, Department of Urology, Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
M.D. Anderson Cancer Center, Houston, Texas, United States
Virginia Oncology Associates, Hampton, Virginia, United States
Virginia Oncology Associates, Newport News, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Seattle Urology Research Center, Burien, Washington, United States
Roger D. Fincher, M.D., P.S., Spokane, Washington, United States
Andreou Research, Surrey, British Columbia, Canada
Surrey Memorial Hospital, Surrey, British Columbia, Canada
Guelph General Hospital, Guelph, Ontario, Canada
Guelph Nuclear Imaging, Guelph, Ontario, Canada
Guelph Urology Associates, Guelph, Ontario, Canada
Office of Dr. Bernard Goldfarb, North Bay, Ontario, Canada
2150935 Ontario Inc., Owen Sound, Ontario, Canada
3030 Lawrence Ave East, Scarborough, Ontario, Canada
Institute of Clinical Sciences, Dept. of Urology / Sahlgrenska University Hospital, Goteborg, , Sweden
University Hospital, Department of Urology, Malmo, , Sweden
Dept. of Urology, Akademiska Sjukhuset, Uppsala, , Sweden
Name: Goran Forsberg, Assoc. Prof.
Affiliation: Active Biotech AB
Role: STUDY_DIRECTOR
Name: Roberto Pili, MD
Affiliation: Roswell Park Cancer Institute, Buffalo, New York
Role: PRINCIPAL_INVESTIGATOR