Adjuvant 3DCRT/IMRT in Combination With Androgen Suppression and Docetaxel for High Risk Prostate Cancer Patients Post-Prostatectomy: A Phase II Trial
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 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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Freedom from progression at 2 years
No
Mark Hurwitz, MD
Study Chair
Dana-Farber/Brigham and Women's Cancer Center
United States: Federal Government
CDR0000563917
NCT00528866
April 2008
Name | Location |
---|---|
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota 55109 |
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
Tulane Cancer Center Office of Clinical Research | Alexandria, Louisiana 71315-3198 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge, Louisiana 70809 |
CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
Forsyth Regional Cancer Center at Forsyth Medical Center | Winston-Salem, North Carolina 27103 |
Delaware County Regional Cancer Center at Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Poudre Valley Radiation Oncology | Fort Collins, Colorado 80528 |
Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
Cancer Treatment Center | Wooster, Ohio 44691 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Barberton Citizens Hospital | Barberton, Ohio 44203 |
St. Luke's Cancer Network at St. Luke's Hospital | Bethlehem, Pennsylvania 18015 |
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
Fox Chase Cancer Center CCOP Research Base | Philadelphia, Pennsylvania 19140 |
Arizona Oncology Services Foundation | Phoenix, Arizona 85013 |
Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Community Memorial Hospital Cancer Care Center | Menomonee Falls, Wisconsin 53051 |
Cancer Institute at St. John's Hospital | Springfield, Illinois 62701 |
Crozer-Chester Medical Center | Upland, Pennsylvania 19013 |
Solano Radiation Oncology Center | Vacaville, California 95687 |
Mercy General Hospital | Sacramento, California 95819 |
Cancer Care Center, Incorporated | Salem, Ohio 44460 |
Cancer Institute of Cape Girardeau, LLC | Cape Girardeau, Missouri 63703 |
Cancer Centers of North Carolina - Raleigh | Raleigh, North Carolina 27607 |
Precision Radiotherapy at University Pointe | West Chester, Ohio 45069 |
Hudner Oncology Center at Saint Anne's Hospital - Fall River | Fall River, Massachusetts 02721 |
Integris Oncology Services | Oklahoma City, Oklahoma 73112 |
University Medical Center at Princeton | Princeton, New Jersey 08540 |
Auburn Radiation Oncology | Auburn, California 95603 |
Radiation Oncology Centers - Cameron Park | Cameron Park, California 95682 |
Radiation Oncology Center - Roseville | Roseville, California 95661 |
Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael, California 95608 |
Nevada Cancer Institute | Las Vegas, Nevada 89135 |
Norton Suburban Hospital | Louisville, Kentucky 40207 |
Urology Center of Colorado | Denver, Colorado 80211 |
Fox Chase Cancer Center Buckingham | Furlong, Pennsylvania 18925 |