A Phase II Study of External Beam Radiation Therapy Combined With Permanent Source Brachytherapy for Intermediate Risk Clinically Localized Adenocarcinoma of the Prostate
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
A Phase II Study of External Beam Radiation Therapy Combined With Permanent Source Brachytherapy for Intermediate Risk Clinically Localized Adenocarcinoma of the Prostate
OBJECTIVES: I. Determine the acute and late grade 3-5 genitourinary and gastrointestinal
toxic effects of external beam radiotherapy followed by permanent source brachytherapy using
interstitial iodine I 125 seeds in patients with intermediate risk, clinically localized
adenocarcinoma of the prostate. II. Determine the freedom from PSA failure, overall
survival, disease specific survival, and local and/or distant clinical relapse rates in
patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients undergo external beam radiotherapy (EBRT) to
the pelvis 5 days a week for 5 weeks. Permanent source brachytherapy comprised of
ultrasound-guided implantation of iodine I 125 seeds into the prostate is performed 2-6
weeks after completion of EBRT. Patients are followed at 1, 3, 6, 9, and 12 months, then
every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 1 year.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven locally confined adenocarcinoma of the
prostate Clinical stage T1c-T2b, NX or N0, M0 Gleason score 2-6 AND PSA greater than 10
ng/dL but no greater than 20 ng/dL OR Gleason score 7 AND PSA no greater than 20 ng/dL
Prostate volume no greater than 60 mL by transrectal ultrasound prior to external beam
radiotherapy American Urologic Association voiding symptoms score no greater than 18 No
distant metastases
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Zubrod 0-1 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other:
No hip prosthesis No other malignancy within the past 5 years except basal cell or
squamous cell skin cancer No major medical or psychiatric illness that would preclude
study Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Prior induction hormonal therapy allowed only if started
no more than 6 months prior to study Radiotherapy: See Disease Characteristics No prior
radiotherapy to pelvis Surgery: No prior transurethral resection of prostate No radical
surgery for carcinoma of the prostate
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
W. Robert Lee, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Comprehensive Cancer Center of Wake Forest University
Authority:
United States: Federal Government
Study ID:
CDR0000068238
NCT ID:
NCT00006365
Start Date:
November 2000
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- Adenocarcinoma
- Prostatic Neoplasms
Name | Location |
|---|---|
| Akron City Hospital | Akron, Ohio 44304 |
| Arizona Cancer Center | Tucson, Arizona 85724 |
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Bowman Gray School of Medicine | Winston Salem, North Carolina 27157 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| University of Colorado Cancer Center | Denver, Colorado 80262 |
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
| Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
| CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Cancer Center of Albany Medical Center | Albany, New York 12208 |
| State University of New York Health Science Center at Brooklyn | Brooklyn, New York 11203 |
| University of Rochester Cancer Center | Rochester, New York 14642 |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
| Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
| Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
| Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
| University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| St. Luke's Medical Center | Milwaukee, Wisconsin 53215 |
| Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
| Hurley Medical Center | Flint, Michigan 48503 |
| East Carolina University School of Medicine | Greenville, North Carolina 27858-4354 |
| Vermont Cancer Center | Burlington, Vermont 05401-3498 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
| University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
| UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
| Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
| Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
| Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
| CCOP - North Shore University Hospital | Manhasset, New York 11030 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| University of Tennessee, Memphis Cancer Center | Memphis, Tennessee 38103 |
| Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
| CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
| Hahnemann University Hospital | Philadelphia, Pennsylvania 19102-1192 |
| University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
| Bloomington Hospital | Bloomington, Indiana 47402 |
| Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| MD Anderson Cancer Center Orlando | Orlando, Florida 32806 |
| Loyola University Medical Center | Maywood, Illinois 60153 |
| CCOP - Ochsner | New Orleans, Louisiana 70121 |
| CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
| Holden Comprehensive Cancer Center at The University of Iowa | Iowa City, Iowa 52242-1009 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
| Henry Ford Hospital | Detroit, Michigan 48202 |
| Marshfield Clinic | Marshfield, Wisconsin 54449 |
| Huntsville Hospital System | Huntsville, Alabama 35801 |
| Alabama Oncology, LLC | Montgomery, Alabama 36106-2801 |
| Radiation Oncology Associates of West Alabama | Tuscallosa, Alabama 35401 |
| Mount Diablo Medical Center | Concord, California 94524-4110 |
| California Cancer Center | Fresno, California 93720 |
| Saint Agnes Cancer Center | Fresno, California 93720 |
| Glendale Memorial Hospital and Health Center | Glendale, California 91204 |
| Loma Linda University Medical Center | Loma Linda, California 92354 |
| Veterans Affairs Medical Center - Long Beach | Long Beach, California 90822 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| Cancer Care Center | Pomona, California 91767 |
| Radiation Oncology Center - Sacramento | Sacramento, California 95816 |
| O'Connor Hospital | San Jose, California 95128 |
| CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
| David Grant Medical Center | Travis Air Force Base, California 94535 |
| Memorial Hospital Cancer Center | Colorado Springs, Colorado 80909 |
| Lykes Center for Radiation Therapy | Clearwater, Florida 33757-0210 |
| Halifax Medical Center | Daytona Beach, Florida 32114 |
| Radiation Therapy Associates - Fort Myers | Fort Myers, Florida 33901 |
| University of Florida Health Science Center | Gainesville, Florida 32610-0296 |
| Health First Holmes Regional Medical Center | Melbourne, Florida 32901 |
| Baptist Hospital of Miami | Miami, Florida 33176-2197 |
| Florida Radiation Oncology Group | Orange Park, Florida 32073 |
| Gulf Coast Cancer Treatment Center | Panama City, Florida 32405-4587 |
| Sarasota Radiation and Medical Oncology Center | Sarasota, Florida 34233 |
| Medical Center/John B. Amos Community Cancer Center | Columbus, Georgia 31902 |
| InterCommunity Cancer Center at Rome | Rome, Georgia 30161 |
| Northwest Community Hospital | Arlington Heights, Illinois 60005 |
| Northwestern Memorial Hospital | Chicago, Illinois 60611 |
| Ingalls Memorial Hospital | Harvey, Illinois 60426 |
| Lutheran General Cancer Care Center | Park Ridge, Illinois 60068 |
| Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| St. John's Medical Center | Anderson, Indiana 46016 |
| Clarion Health Partners Inc. | Indianapolis, Indiana 46206-1367 |
| Community Hospitals of Indianapolis - Regional Cancer Center | Indianapolis, Indiana 46219 |
| Ball Memorial Hospital | Muncie, Indiana 47303-3499 |
| Wendt Regional Cancer Center of Finley Hospital | Dubuque, Iowa 52001 |
| Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
| James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
| Louisville Radiation Oncology | Louisville, Kentucky 40215 |
| Merle M. Mahr Cancer Center | Madisonville, Kentucky 42431 |
| Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana 70809 |
| Romagosa Radiation Oncology Center | Lafayette, Louisiana 70501 |
| Tulane University School of Medicine | New Orleans, Louisiana 70112 |
| Maine Medical Center | Portland, Maine 04102 |
| Anne Arundel Oncology Center | Annapolis, Maryland 21401 |
| Greater Baltimore Medical Center and Cancer Center | Baltimore, Maryland 21204 |
| Harbor Hospital Center | Baltimore, Maryland 21225 |
| Radiation Oncology Affiliates of Maryland, P.A. | Baltimore, Maryland 21237 |
| Cape Cod Hospital | Hyannis, Massachusetts 02601 |
| Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain, Massachusetts 02130 |
| McLaren Regional Cancer Center | Flint, Michigan 48432 |
| Marquette General Hospital | Marquette, Michigan 49855 |
| St. Mary's Medical Center | Saginaw, Michigan 48601 |
| Mallinckrodt Institute of Radiology | Saint Louis, Missouri 63110 |
| St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
| Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| Methodist Cancer Center - Omaha | Omaha, Nebraska 68114 |
| Elliot Regional Cancer Center | Manchester, New Hampshire 03103 |
| John F. Kennedy Medical Center | Edison, New Jersey 08818 |
| Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
| Community Medical Center | Toms River, New Jersey 08755 |
| St. Francis Medical Center | Trenton, New Jersey 08629 |
| Saint Joseph Medical Center | Albuquerque, New Mexico 87102 |
| New York Methodist Hospital | Brooklyn, New York 11215-3609 |
| Finger Lakes Radiation Oncology, P.C. | Clifton Springs, New York 14432 |
| Beth Israel Medical Center | New York, New York 10003 |
| Champlain Valley Physicians Hospital Medical Center | Plattsburgh, New York 12901 |
| Vassar Brothers Hospital | Poughkeepsie, New York 12601 |
| New York Medical College | Valhalla, New York 10595 |
| Northeast Medical Center | Concord, North Carolina 28025 |
| Catawba Memorial Hospital | Hickory, North Carolina 28601 |
| Meritcare Roger Maris Cancer Center | Fargo, North Dakota 58122 |
| Akron General Medical Center | Akron, Ohio 44302 |
| Christ Hospital | Cincinnati, Ohio 45219 |
| University Hospitals of Cleveland | Cleveland, Ohio 44106 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Columbia River Program | Portland, Oregon 97213 |
| Lehigh Valley Hospital | Allentown, Pennsylvania 18103 |
| St. Luke's Hospital Regional Cancer Center | Bethlehem, Pennsylvania 18015 |
| Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
| Penn State Geisinger Cancer Center | Hershey, Pennsylvania 17033 |
| Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
| Veterans Affairs Medical Center - Philadelphia | Philadelphia, Pennsylvania 19104 |
| Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
| Mercy Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15219 |
| Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
| Mercy Hospital Cancer Center - Scranton | Scranton, Pennsylvania 18501 |
| Grand View Hospital | Sellersville, Pennsylvania 18960 |
| Wilkes Barre General Hospital | Wilkes-Barre, Pennsylvania 18764 |
| CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
| York Hospital | York, Pennsylvania 17315 |
| Roger Williams Medical Center/BUSM | Providence, Rhode Island 02908-4735 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| Jackson-Madison County General Hospital | Jackson, Tennessee 38301 |
| Harrington Cancer Center | Amarillo, Texas 79106 |
| Julie and Ben Rogers Cancer Institute | Beaumont, Texas 77701 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| Wilford Hall - 59th Medical Wing | Lackland Air Force Base, Texas 78236-5300 |
| Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
| Bayshore Medical Center | Pasadena, Texas 77504 |
| East Texas Medical Center - Cancer Institute | Tyler, Texas 75701 |
| Dixie Regional Medical Center | Saint George, Utah 84770 |
| LDS Hospital | Salt Lake City, Utah 84143 |
| CCOP - Southwestern Vermont Regional Cancer Center | Bennington, Vermont 05201 |
| Martha Jefferson Hospital | Charlottesville, Virginia 22901 |
| Naval Medical Center, Portsmouth | Portsmouth, Virginia 23708-2197 |
| Massey Cancer Center | Richmond, Virginia 23298-0037 |
| Virginia Mason Medical Center | Seattle, Washington 98111 |
| Deaconess Medical Center | Spokane, Washington 99210-0248 |
| Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
| St. Vincent Hospital | Green Bay, Wisconsin 54307-3508 |
| Gundersen Lutheran Medical Foundation | La Crosse, Wisconsin 54601 |
| University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
| Southern Wisconsin Radiotherapy Center | Madison, Wisconsin 53713 |
| Community Memorial Hospital | Menomonee Falls, Wisconsin 53051 |
| Columbia Hospital | Milwaukee, Wisconsin 53211 |
| St. Joseph's Hospital | Milwaukee, Wisconsin 53210 |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
| Southeastern Wisconsin Regional Cancer Center | Racine, Wisconsin 53405 |
| Waukesha Memorial Hospital | Waukesha, Wisconsin 53188 |
| MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Cancer Center and Beckman Research Institute, City of Hope | Duarte, California 91010-3000 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
| Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
| Comprehensive Cancer Institute of Huntsville | Huntsville, Alabama 35801 |
| Providence Alaska Medical Center | Anchorage, Alaska 99508 |
| Radiation Medical Group, Inc. | San Diego, California 92101-1492 |
| Veterans Affairs Medical Center - Miami | Miami, Florida 33125 |
| Bay Medical Center | Panama City, Florida 32401 |
| Tallahassee Memorial Healthcare | Tallahassee, Florida 32308 |
| Provena St. Joseph Hospital- Regional Cancer Care Center | Elgin, Illinois 60123 |
| Peninsula Regional Medical Center | Salisbury, Maryland 21801 |
| MidMichigan Medical Center - Midland | Midland, Michigan 48670 |
| William Beaumont Hospital | Royal Oak, Michigan 48073 |
| North Mississippi Medical Center/Cancer Center | Tupelo, Mississippi 38801 |
| Nebraska Health System | Omaha, Nebraska 68105-1018 |
| Trinitas Hospital - Jersey Street Campus | Elizabeth, New Jersey 07201 |
| Monmouth Medical Center | Long Branch, New Jersey 07740-6395 |
| South Jersey Regional Cancer Center | Millville, New Jersey 08332 |
| Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County | Mount Holly, New Jersey 08060 |
| Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
| Atlantic City Medical Center | Pomona, New Jersey 08240 |
| Associated Radiologists, P.A. | Warren, New Jersey 07059 |
| St. Anthony Hospital | Oklahoma City, Oklahoma 73101 |
| St. John Health System | Tulsa, Oklahoma 74104 |
| University of Utah Health Sciences Center | Salt Lake City, Utah 84132 |
| RMH Regional Canter Center | Harrisonburg, Virginia 22801 |
| Schiffler Cancer Center | Wheeling, West Virginia 26003 |
| Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
| Sutter Health West Cancer Research Group | Greenbrae, California 94904 |
| Huntington Cancer Center | Pasadena, California 91105 |
| Saint Mary's Hospital and Medical Center | Grand Junction, Colorado 81502-1628 |
| Central Baptist Hospital | Lexington, Kentucky 40503 |
| William Beaumont Hospital - Troy | Troy, Michigan 48098 |
| Valley Hospital | Ridgewood, New Jersey 07450 |
| Riverhill Radiation Oncology | Yonkers, New York 10701 |
| Trinity Cancer Care Center | Minot, North Dakota 58701 |
| Pocono Cancer Center | East Stroudsburg, Pennsylvania 18301 |
| Bon-Secours - St. Mary's Hospital | Richmond, Virginia 23226 |
| Fitzgerald Mercy Hospital | Darby, Pennsylvania 19023 |
