Spots Global Cancer Trial Database for Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy
Official Title: Adjuvant 3DCRT/IMRT in Combination With Androgen Suppression and Docetaxel for High Risk Prostate Cancer Patients Post-Prostatectomy: A Phase II Trial
Study ID: NCT00528866
Conditions
Study Description
Brief Summary: RATIONALE: Specialized radiation therapy that delivers a high-dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide, goserelin, flutamide, or bicalutamide, may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with androgen suppression and docetaxel after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving radiation therapy together with androgen suppression and docetaxel works in treating patients with high risk prostate cancer who have undergone radical prostatectomy.
Detailed Description: OBJECTIVES: Primary * To assess whether the addition of androgen suppression therapy and docetaxel to adjuvant radiotherapy improves freedom from progression. Secondary * To assess freedom from local-regional progression, distant metastases, disease-free survival, prostate cancer specific survival, non-prostate cancer specific survival, overall survival, and time to biochemical (PSA) failure. * To evaluate treatment-related "acute" and "late" toxicity based on Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0. * To correlate genomic and proteomic biomarkers with the primary and secondary clinical endpoints utilizing archival prostatectomy tissue and pretreatment and prospectively collected serum/plasma. OUTLINE: This is a multicenter study. * Androgen suppression therapy: Patients receive a luteinizing hormone-releasing hormone (LHRH) agonist (leuprolide or goserelin) as an injection AND an oral antiandrogen (flutamide 3 times daily or bicalutamide once daily) for up to 6 months. * Radiotherapy: Beginning 8 weeks after the initiation of androgen suppression therapy, patients undergo 3-dimensional conformal radiotherapy or intensity-modulated radiotherapy once a day 5 days a week for up to approximately 8 weeks. * Chemotherapy: Beginning 3-6 weeks after the completion of radiotherapy, patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses. After the completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Arizona Oncology Services Foundation, Phoenix, Arizona, United States
Auburn Radiation Oncology, Auburn, California, United States
Radiation Oncology Centers - Cameron Park, Cameron Park, California, United States
Mercy Cancer Center at Mercy San Juan Medical Center, Carmichael, California, United States
Radiation Oncology Center - Roseville, Roseville, California, United States
Radiological Associates of Sacramento Medical Group, Incorporated, Sacramento, California, United States
Mercy General Hospital, Sacramento, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Solano Radiation Oncology Center, Vacaville, California, United States
Urology Center of Colorado, Denver, Colorado, United States
Poudre Valley Radiation Oncology, Fort Collins, Colorado, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
Cancer Institute at St. John's Hospital, Springfield, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Norton Suburban Hospital, Louisville, Kentucky, United States
Tulane Cancer Center Office of Clinical Research, Alexandria, Louisiana, United States
Mary Bird Perkins Cancer Center - Baton Rouge, Baton Rouge, Louisiana, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Hudner Oncology Center at Saint Anne's Hospital - Fall River, Fall River, Massachusetts, United States
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States
Minnesota Oncology Hematology, PA - Maplewood, Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale, Minnesota, United States
CentraCare Clinic - River Campus, Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Regional Cancer Center at Singing River Hospital, Pascagoula, Mississippi, United States
Cancer Institute of Cape Girardeau, LLC, Cape Girardeau, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri, United States
Nevada Cancer Institute, Las Vegas, Nevada, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton, Marlton, New Jersey, United States
Newark Beth Israel Medical Center, Newark, New Jersey, United States
University Medical Center at Princeton, Princeton, New Jersey, United States
Mission Hospitals - Memorial Campus, Asheville, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States
Wayne Radiation Oncology, Goldsboro, North Carolina, United States
Pardee Memorial Hospital, Hendersonville, North Carolina, United States
Cancer Centers of North Carolina - Raleigh, Raleigh, North Carolina, United States
Forsyth Regional Cancer Center at Forsyth Medical Center, Winston-Salem, North Carolina, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio, United States
Barberton Citizens Hospital, Barberton, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States
Cancer Care Center, Incorporated, Salem, Ohio, United States
Precision Radiotherapy at University Pointe, West Chester, Ohio, United States
Cancer Treatment Center, Wooster, Ohio, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States
Integris Oncology Services, Oklahoma City, Oklahoma, United States
St. Luke's Cancer Network at St. Luke's Hospital, Bethlehem, Pennsylvania, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital, Drexel Hill, Pennsylvania, United States
Fox Chase Cancer Center Buckingham, Furlong, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center CCOP Research Base, Philadelphia, Pennsylvania, United States
Crozer-Chester Medical Center, Upland, Pennsylvania, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center, Murray, Utah, United States
CCOP - Virginia Mason Research Center, Seattle, Washington, United States
Community Memorial Hospital Cancer Care Center, Menomonee Falls, Wisconsin, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
McGill Cancer Centre at McGill University, Montreal, Quebec, Canada
Contact Details
Name: Mark Hurwitz, MD
Affiliation: Thomas Jefferson University and Hospitals
Role: PRINCIPAL_INVESTIGATOR
Name: Oliver Sartor, MD
Affiliation: Dana-Farber Cancer Institute
Role: STUDY_CHAIR
Name: Ying Xiao, PhD
Affiliation: Bodine Center for Cancer Treatment at Thomas Jefferson University Hospital
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
