External-Beam Radiation Therapy Plus Implanted Radiation Therapy in Treating Patients With Prostate Cancer

October 21, 2020 updated by: Radiation Therapy Oncology Group

A Phase II Study of External Beam Radiation Therapy Combined With Permanent Source Brachytherapy for Intermediate Risk Clinically Localized Adenocarcinoma of the Prostate

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of external-beam radiation therapy followed by implanted radiation therapy in treating patients who have prostate cancer.

Study Overview

Status

Completed

Conditions

Prostate Cancer

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the acute and late grade 3-5 genitourinary (GU) and gastrointestinal (GI) 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 prostate specific antigen (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.

Study Type

Interventional

Enrollment (Actual)

138

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Tom Baker Cancer Center - Calgary
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 4E6
    - British Columbia Cancer Agency
- New Brunswick
  - Saint John, New Brunswick, Canada, E2L 4L2
    - Saint John Regional Hospital
- Newfoundland and Labrador
  - St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
    - Newfoundland Cancer Treatment and Research Foundation
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V7
    - Nova Scotia Cancer Centre
- Ontario
  - Hamilton, Ontario, Canada, L8V 5C2
    - Cancer Care Ontario-Hamilton Regional Cancer Centre
  - Kingston, Ontario, Canada, K7L 5P9
    - Kingston Regional Cancer Centre
  - London, Ontario, Canada, N6A 4L6
    - Cancer Care Ontario-London Regional Cancer Centre
  - Ottawa, Ontario, Canada, K1H 1C4
    - Ottawa Regional Cancer Centre - General Campus
  - Sudbury, Ontario, Canada, P3E 5J1
    - Northeastern Ontario Regional Cancer Centre, Sudbury
  - Thunder Bay, Ontario, Canada, P7A 7T1
    - Northwestern Ontario Regional Cancer Centre, Thunder Bay
  - Toronto, Ontario, Canada, M4N 3M5
    - Toronto Sunnybrook Regional Cancer Centre
  - Toronto, Ontario, Canada, M5G 2M9
    - Princess Margaret Hospital
- Quebec
  - Fleurimont, Quebec, Canada, J1H 5N4
    - CHUS-Hopital Fleurimont
  - Montreal, Quebec, Canada, H2W 1S6
    - McGill University
  - Quebec City, Quebec, Canada, G1R 2J6
    - CHU de Quebec - L'Hotel-Dieu de Quebec
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4T 7T1
    - Allan Blair Cancer Centre
  - Saskatoon, Saskatchewan, Canada, S7N 4H4
    - Saskatoon Cancer Centre
United States
- Alabama
  - Birmingham, Alabama, United States, 35294-3300
    - University of Alabama at Birmingham Comprehensive Cancer Center
  - Huntsville, Alabama, United States, 35801
    - Comprehensive Cancer Institute of Huntsville
  - Huntsville, Alabama, United States, 35801-4470
    - Huntsville Hospital System
  - Mobile, Alabama, United States, 36688
    - MBCCOP - Gulf Coast
  - Montgomery, Alabama, United States, 36106-2801
    - Alabama Oncology, LLC
  - Tuscaloosa, Alabama, United States, 35401
    - Radiation Oncology Associates of West Alabama
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Providence Alaska Medical Center
- Arizona
  - Tucson, Arizona, United States, 85724
    - Arizona Cancer Center
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - University of Arkansas for Medical Sciences
- California
  - Concord, California, United States, 94524-4110
    - Mount Diablo Medical Center
  - Duarte, California, United States, 91010-3000
    - Cancer Center and Beckman Research Institute, City of Hope
  - Fresno, California, United States, 93720
    - California Cancer Center
  - Fresno, California, United States, 93720
    - Saint Agnes Cancer Center
  - Glendale, California, United States, 91204
    - Glendale Memorial Hospital and Health Center
  - Greenbrae, California, United States, 94904
    - Sutter Health West Cancer Research Group
  - La Jolla, California, United States, 92093-0658
    - University of California San Diego Cancer Center
  - Loma Linda, California, United States, 92354
    - Loma Linda University Medical Center
  - Long Beach, California, United States, 90822
    - Veterans Affairs Medical Center - Long Beach
  - Los Angeles, California, United States, 90095-1781
    - Jonsson Comprehensive Cancer Center, UCLA
  - Los Angeles, California, United States, 90033-0804
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Oakland, California, United States, 94609-3305
    - CCOP - Bay Area Tumor Institute
  - Pasadena, California, United States, 91105
    - Huntington Cancer Center
  - Pomona, California, United States, 91767
    - Cancer Care Center
  - Sacramento, California, United States, 95816
    - Radiation Oncology Center - Sacramento
  - San Diego, California, United States, 92101-1492
    - Radiation Medical Group, Inc.
  - San Francisco, California, United States, 94143-0128
    - UCSF Cancer Center and Cancer Research Institute
  - San Jose, California, United States, 95128
    - O'Connor Hospital
  - Santa Rosa, California, United States, 95403
    - CCOP - Santa Rosa Memorial Hospital
  - Travis Air Force Base, California, United States, 94535
    - David Grant Medical Center
- Colorado
  - Colorado Springs, Colorado, United States, 80909
    - Memorial Hospital Cancer Center
  - Denver, Colorado, United States, 80010
    - University Of Colorado Cancer Center
  - Grand Junction, Colorado, United States, 81502
    - Saint Mary's Hospital and Medical Center
- Delaware
  - Wilmington, Delaware, United States, 19899
    - CCOP - Christiana Care Health Services
- District of Columbia
  - Washington, District of Columbia, United States, 20307-5000
    - Walter Reed Army Medical Center
- Florida
  - Clearwater, Florida, United States, 33757-0210
    - Lykes Center for Radiation Therapy
  - Daytona Beach, Florida, United States, 32114
    - Halifax Medical Center
  - Fort Myers, Florida, United States, 33901
    - Radiation Therapy Associates - Fort Myers
  - Gainesville, Florida, United States, 32610-0296
    - University of Florida Health Science Center
  - Melbourne, Florida, United States, 32901
    - Health First Holmes Regional Medical Center
  - Miami, Florida, United States, 33136
    - Sylvester Cancer Center, University of Miami
  - Miami, Florida, United States, 33176-2197
    - Baptist Hospital of Miami
  - Miami, Florida, United States, 33125
    - Veterans Affairs Medical Center - Miami
  - Miami Beach, Florida, United States, 33140
    - CCOP - Mount Sinai Medical Center
  - Orange Park, Florida, United States, 32073
    - Florida Radiation Oncology Group
  - Orlando, Florida, United States, 32806
    - MD Anderson Cancer Center Orlando
  - Panama City, Florida, United States, 32405-4587
    - Gulf Coast Cancer Treatment Center
  - Panama City, Florida, United States, 32401
    - Bay Medical Center
  - Sarasota, Florida, United States, 34233
    - Sarasota Radiation and Medical Oncology Center
  - Tallahassee, Florida, United States, 32308
    - Tallahassee Memorial HealthCare
  - Tampa, Florida, United States, 33612-9497
    - H. Lee Moffitt Cancer Center and Research Institute
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Emory University Hospital - Atlanta
  - Atlanta, Georgia, United States, 30342-1701
    - CCOP - Atlanta Regional
  - Columbus, Georgia, United States, 31902
    - Medical Center/John B. Amos Community Cancer Center
  - Rome, Georgia, United States, 30161
    - InterCommunity Cancer Center at Rome
- Illinois
  - Arlington Heights, Illinois, United States, 60005
    - Northwest Community Hospital
  - Chicago, Illinois, United States, 60637-1470
    - University of Chicago Cancer Research Center
  - Chicago, Illinois, United States, 60611
    - Northwestern Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - CCOP - Central Illinois
  - Elgin, Illinois, United States, 60123
    - Provena St. Joseph Hospital- Regional Cancer Care Center
  - Harvey, Illinois, United States, 60426
    - Ingalls Memorial Hospital
  - Maywood, Illinois, United States, 60153
    - Loyola University Medical Center
  - Park Ridge, Illinois, United States, 60068
    - Lutheran General Cancer Care Center
  - Peoria, Illinois, United States, 61636
    - Methodist Medical Center of Illinois
- Indiana
  - Anderson, Indiana, United States, 46016
    - St. John's Medical Center
  - Bloomington, Indiana, United States, 47402
    - Bloomington Hospital
  - Indianapolis, Indiana, United States, 46202
    - Veterans Affairs Medical Center - Indianapolis (Roudebush)
  - Indianapolis, Indiana, United States, 46206-1367
    - Clarion Health Partners Inc.
  - Indianapolis, Indiana, United States, 46219
    - Community Hospitals of Indianapolis - Regional Cancer Center
  - Muncie, Indiana, United States, 47303-3499
    - Ball Memorial Hospital
- Iowa
  - Dubuque, Iowa, United States, 52001
    - Wendt Regional Cancer Center of Finley Hospital
  - Iowa City, Iowa, United States, 52242-1009
    - Holden Comprehensive Cancer Center at the University of Iowa
- Kentucky
  - Lexington, Kentucky, United States, 40511-1093
    - Veterans Affairs Medical Center - Lexington
  - Lexington, Kentucky, United States, 40536-0084
    - Albert B. Chandler Medical Center, University of Kentucky
  - Lexington, Kentucky, United States, 40503
    - Central Baptist Hospital
  - Louisville, Kentucky, United States, 40202
    - James Graham Brown Cancer Center
  - Louisville, Kentucky, United States, 40215
    - Louisville Radiation Oncology
  - Madisonville, Kentucky, United States, 42431
    - Merle M. Mahr Cancer Center
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Mary Bird Perkins Cancer Center
  - Lafayette, Louisiana, United States, 70501
    - Romagosa Radiation Oncology Center
  - New Orleans, Louisiana, United States, 70112
    - Tulane University School of Medicine
  - New Orleans, Louisiana, United States, 70121
    - CCOP - Ochsner
  - New Orleans, Louisiana, United States, 70112
    - MBCCOP - LSU Health Sciences Center
- Maine
  - Portland, Maine, United States, 04102
    - Maine Medical Center
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Anne Arundel Oncology Center
  - Baltimore, Maryland, United States, 21225
    - Sinai Hospital of Baltimore
  - Baltimore, Maryland, United States, 21204
    - Greater Baltimore Medical Center and Cancer Center
  - Baltimore, Maryland, United States, 21225
    - Harbor Hospital Center
  - Baltimore, Maryland, United States, 21237
    - Radiation Oncology Affiliates of Maryland, P.A.
  - Baltimore, Maryland, United States, 21231-2410
    - Johns Hopkins Oncology Center
  - Salisbury, Maryland, United States, 21801
    - Peninsula Regional Medical Center
- Massachusetts
  - Hyannis, Massachusetts, United States, 02601
    - Cape Cod Hospital
  - Jamaica Plain, Massachusetts, United States, 02130
    - Veterans Affairs Medical Center - Boston (Jamaica Plain)
- Michigan
  - Ann Arbor, Michigan, United States, 48109-0752
    - University of Michigan Comprehensive Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - CCOP - Ann Arbor Regional
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
  - Detroit, Michigan, United States, 48201-1379
    - Barbara Ann Karmanos Cancer Institute
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48432
    - McLaren Regional Cancer Center
  - Kalamazoo, Michigan, United States, 49007-3731
    - CCOP - Kalamazoo
  - Marquette, Michigan, United States, 49855
    - Marquette General Hospital
  - Midland, Michigan, United States, 48670
    - MidMichigan Medical Center - Midland
  - Royal Oak, Michigan, United States, 48073
    - William Beaumont Hospital
  - Saginaw, Michigan, United States, 48601
    - St. Mary's Medical Center
  - Troy, Michigan, United States, 48098
    - William Beaumont Hospital - Troy
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic Cancer Center
  - Saint Louis Park, Minnesota, United States, 55416
    - CCOP - Metro-Minnesota
- Mississippi
  - Tupelo, Mississippi, United States, 38801
    - North Mississippi Medical Center/Cancer Center
- Missouri
  - Columbia, Missouri, United States, 65203
    - Ellis Fischel Cancer Center - Columbia
  - Kansas City, Missouri, United States, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, United States, 63110-0250
    - St. Louis University Health Sciences Center
  - Saint Louis, Missouri, United States, 63110
    - Mallinckrodt Institute of Radiology
  - Springfield, Missouri, United States, 65807
    - CCOP - Cancer Research for the Ozarks
  - Springfield, Missouri, United States, 65807
    - Cancer Research for the Ozarks
- Montana
  - Billings, Montana, United States, 59101
    - CCOP - Montana Cancer Consortium
- Nebraska
  - Omaha, Nebraska, United States, 68114
    - Methodist Cancer Center - Omaha
  - Omaha, Nebraska, United States, 68105-1018
    - Nebraska Health System
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - CCOP - Southern Nevada Cancer Research Foundation
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756-0002
    - Norris Cotton Cancer Center
  - Manchester, New Hampshire, United States, 03103
    - Elliot Regional Cancer Center
- New Jersey
  - East Orange, New Jersey, United States, 07018-1095
    - Veterans Affairs Medical Center - East Orange
  - Edison, New Jersey, United States, 08818
    - John F. Kennedy Medical Center
  - Elizabeth, New Jersey, United States, 07201
    - Trinitas Hospital - Jersey Street Campus
  - Long Branch, New Jersey, United States, 07740-6395
    - Monmouth Medical Center
  - Millville, New Jersey, United States, 08332
    - South Jersey Regional Cancer Center
  - Mount Holly, New Jersey, United States, 08060
    - Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
  - New Brunswick, New Jersey, United States, 08901
    - Cancer Institute Of New Jersey
  - Newark, New Jersey, United States, 07112
    - Newark Beth Israel Medical Center
  - Pomona, New Jersey, United States, 08240
    - Atlantic City Medical Center
  - Ridgewood, New Jersey, United States, 07450
    - Valley Hospital
  - Toms River, New Jersey, United States, 08755
    - Community Medical Center
  - Trenton, New Jersey, United States, 08629
    - St. Francis Medical Center
  - Warren, New Jersey, United States, 07059
    - Associated Radiologists, P.A.
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - Saint Joseph Medical Center
- New York
  - Albany, New York, United States, 12208
    - Cancer Center of Albany Medical Center
  - Bronx, New York, United States, 10461
    - Albert Einstein Comprehensive Cancer Center
  - Brooklyn, New York, United States, 11203
    - State University of New York Health Science Center at Brooklyn
  - Brooklyn, New York, United States, 11215-3609
    - New York Methodist Hospital
  - Buffalo, New York, United States, 14263-0001
    - Roswell Park Cancer Institute
  - Clifton Springs, New York, United States, 14432
    - Finger Lakes Radiation Oncology, P.C.
  - Manhasset, New York, United States, 11030
    - CCOP - North Shore University Hospital
  - New York, New York, United States, 10021
    - Memorial Sloan-Kettering Cancer Center
  - New York, New York, United States, 10003
    - Beth Israel Medical Center
  - New York, New York, United States, 10032
    - Herbert Irving Comprehensive Cancer Center
  - Plattsburgh, New York, United States, 12901
    - Champlain Valley Physicians Hospital Medical Center
  - Poughkeepsie, New York, United States, 12601
    - Vassar Brothers Hospital
  - Rochester, New York, United States, 14642
    - University of Rochester Cancer Center
  - Valhalla, New York, United States, 10595
    - New York Medical College
  - Yonkers, New York, United States, 10701
    - Riverhill Radiation Oncology
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599-7295
    - Lineberger Comprehensive Cancer Center, UNC
  - Concord, North Carolina, United States, 28025
    - Northeast Medical Center
  - Greenville, North Carolina, United States, 27858-4354
    - East Carolina University School of Medicine
  - Hickory, North Carolina, United States, 28601
    - Catawba Memorial Hospital
  - Winston-Salem, North Carolina, United States, 27104-4241
    - CCOP - Southeast Cancer Control Consortium
  - Winston-Salem, North Carolina, United States, 27157-1082
    - Comprehensive Cancer Center at Wake Forest University
  - Winston-Salem, North Carolina, United States, 27157
    - Bowman Gray School of Medicine
- North Dakota
  - Fargo, North Dakota, United States, 58122
    - Meritcare Roger Maris Cancer Center
  - Minot, North Dakota, United States, 58701
    - Trinity Cancer Care Center
- Ohio
  - Akron, Ohio, United States, 44302
    - Akron General Medical Center
  - Akron, Ohio, United States, 44309
    - Akron City Hospital
  - Cincinnati, Ohio, United States, 45219
    - Barrett Cancer Center, The University Hospital
  - Cincinnati, Ohio, United States, 45219
    - Christ Hospital
  - Cleveland, Ohio, United States, 44106
    - University Hospitals of Cleveland
  - Cleveland, Ohio, United States, 44106-5065
    - Ireland Cancer Center
  - Columbus, Ohio, United States, 43210-1240
    - Arthur G. James Cancer Hospital - Ohio State University
  - Columbus, Ohio, United States, 43206
    - CCOP - Columbus
  - Kettering, Ohio, United States, 45429
    - CCOP - Dayton
  - Toledo, Ohio, United States, 43623-3456
    - CCOP - Toledo Community Hospital Oncology Program
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - Oklahoma University Medical Center
  - Oklahoma City, Oklahoma, United States, 73101
    - St. Anthony Hospital
  - Tulsa, Oklahoma, United States, 74104
    - St. John Health System
- Oregon
  - Portland, Oregon, United States, 97213
    - CCOP - Columbia River Program
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18103
    - Lehigh Valley Hospital
  - Bethlehem, Pennsylvania, United States, 18015
    - St. Luke's Hospital Regional Cancer Center
  - Danville, Pennsylvania, United States, 17822-2001
    - Geisinger Medical Center
  - Darby, Pennsylvania, United States, 19023
    - Fitzgerald Mercy Hospital
  - Drexel Hill, Pennsylvania, United States, 19026
    - Delaware County Memorial Hospital
  - East Stroudsburg, Pennsylvania, United States, 18301
    - Pocono Cancer Center
  - Hershey, Pennsylvania, United States, 17033
    - Penn State Geisinger Cancer Center
  - Philadelphia, Pennsylvania, United States, 19111
    - Fox Chase Cancer Center
  - Philadelphia, Pennsylvania, United States, 19104
    - Veterans Affairs Medical Center - Philadelphia
  - Philadelphia, Pennsylvania, United States, 19141
    - Albert Einstein Cancer Center
  - Philadelphia, Pennsylvania, United States, 19102-1192
    - Hahnemann University Hospital
  - Philadelphia, Pennsylvania, United States, 19104-4283
    - University of Pennsylvania Cancer Center
  - Philadelphia, Pennsylvania, United States, 19107-5541
    - Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
  - Pittsburgh, Pennsylvania, United States, 15224
    - Western Pennsylvania Hospital
  - Pittsburgh, Pennsylvania, United States, 15213-3489
    - University of Pittsburgh Cancer Institute
  - Pittsburgh, Pennsylvania, United States, 15219
    - Mercy Hospital of Pittsburgh
  - Reading, Pennsylvania, United States, 19612-6052
    - Reading Hospital and Medical Center
  - Scranton, Pennsylvania, United States, 18501
    - Mercy Hospital Cancer Center - Scranton
  - Sellersville, Pennsylvania, United States, 18960
    - Grand View Hospital
  - Wilkes-Barre, Pennsylvania, United States, 18764
    - Wilkes Barre General Hospital
  - Wynnewood, Pennsylvania, United States, 19096
    - CCOP - MainLine Health
  - York, Pennsylvania, United States, 17315
    - York Hospital
- Rhode Island
  - Providence, Rhode Island, United States, 02908-4735
    - Roger Williams Medical Center/BUSM
- South Carolina
  - Charleston, South Carolina, United States, 29425-0721
    - Medical University of South Carolina
  - Greenville, South Carolina, United States, 29615
    - CCOP - Greenville
  - Spartanburg, South Carolina, United States, 29303
    - CCOP - Upstate Carolina
- South Dakota
  - Rapid City, South Dakota, United States, 57709
    - Rapid City Regional Hospital
- Tennessee
  - Jackson, Tennessee, United States, 38301
    - Jackson-Madison County General Hospital
  - Memphis, Tennessee, United States, 38103
    - University of Tennessee, Memphis Cancer Center
  - Nashville, Tennessee, United States, 37232-6838
    - Vanderbilt-Ingram Cancer Center
- Texas
  - Amarillo, Texas, United States, 79106
    - Harrington Cancer Center
  - Beaumont, Texas, United States, 77701
    - Julie and Ben Rogers Cancer Institute
  - Galveston, Texas, United States, 77555-0209
    - University of Texas Medical Branch
  - Houston, Texas, United States, 77030-4009
    - University of Texas - MD Anderson Cancer Center
  - Lackland Air Force Base, Texas, United States, 78236-5300
    - Wilford Hall - 59th Medical Wing
  - Lubbock, Texas, United States, 79410-1894
    - Joe Arrington Cancer Research and Treatment Center
  - Pasadena, Texas, United States, 77504
    - Bayshore Medical Center
  - Tyler, Texas, United States, 75701
    - East Texas Medical Center - Cancer Institute
- Utah
  - Saint George, Utah, United States, 84770
    - Dixie Regional Medical Center
  - Salt Lake City, Utah, United States, 84132
    - University of Utah Health Sciences Center
  - Salt Lake City, Utah, United States, 84143
    - LDS Hospital
- Vermont
  - Bennington, Vermont, United States, 05201
    - CCOP - Southwestern Vermont Regional Cancer Center
  - Burlington, Vermont, United States, 05401-3498
    - Vermont Cancer Center
- Virginia
  - Charlottesville, Virginia, United States, 22901
    - Martha Jefferson Hospital
  - Charlottesville, Virginia, United States, 22908
    - Cancer Center at the University of Virginia
  - Harrisonburg, Virginia, United States, 22801
    - RMH Regional Canter Center
  - Portsmouth, Virginia, United States, 23708-2197
    - Naval Medical Center, Portsmouth
  - Richmond, Virginia, United States, 23298-0037
    - Massey Cancer Center
  - Richmond, Virginia, United States, 23226
    - Bon-Secours - St. Mary's Hospital
- Washington
  - Seattle, Washington, United States, 98111
    - Virginia Mason Medical Center
  - Spokane, Washington, United States, 99210-0248
    - Deaconess Medical Center
  - Yakima, Washington, United States, 98902
    - Yakima Valley Memorial Hospital
- West Virginia
  - Wheeling, West Virginia, United States, 26003
    - Schiffler Cancer Center
- Wisconsin
  - Green Bay, Wisconsin, United States, 54307-3508
    - St. Vincent Hospital
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Medical Foundation
  - Madison, Wisconsin, United States, 53792-6164
    - University of Wisconsin Comprehensive Cancer Center
  - Madison, Wisconsin, United States, 53713
    - Southern Wisconsin Radiotherapy Center
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Clinic
  - Menomonee Falls, Wisconsin, United States, 53051
    - Community Memorial Hospital
  - Milwaukee, Wisconsin, United States, 53210
    - St. Joseph's Hospital
  - Milwaukee, Wisconsin, United States, 53211
    - Columbia Hospital
  - Milwaukee, Wisconsin, United States, 53215
    - St. Luke's Medical Center
  - Milwaukee, Wisconsin, United States, 53295
    - Veterans Affairs Medical Center - Milwaukee (Zablocki)
  - Racine, Wisconsin, United States, 53405
    - Southeastern Wisconsin Regional Cancer Center
  - Waukesha, Wisconsin, United States, 53188
    - Waukesha Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EBRT to the prostate followed by brachytherapy Patients received 45 Gy of external beam radiation therapy (EBRT)to the prostate followed (within 2 to 6 weeks) by permanent iodine (I-125) brachytherapy 108 Gy.	Radiation: radiation therapy Radiation: brachytherapy Radiation: iodine I 125

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of late severe GU and GI toxicity Time Frame: Start of radiotherapy to at least 18 months of follow-up	Rate of late severe GU and GI toxicity defined as grade 3-5 GU and GI toxicity based on Common Toxicity Criteria 2.0	Start of radiotherapy to at least 18 months of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of acute severe GU and GI toxicity Time Frame: Nine months from the start of radiotherapy	Rate of acute severe GU and GI toxicity, defined as grde 3-5 GU and GI toxicity based on Common Toxicity Criteria 2.0	Nine months from the start of radiotherapy
Biochemical Failure Time Frame: From the date of study entry to the date of first occurrence of PSA failure once by ASTRO definition of 3 years of follow-up been completed for all patients		From the date of study entry to the date of first occurrence of PSA failure once by ASTRO definition of 3 years of follow-up been completed for all patients
Overall failure Time Frame: From the date of study entry to the date of death due to any cause		From the date of study entry to the date of death due to any cause
Failure rate of clinical progression including local-regional/distant failure Time Frame: Documented evidence of local progression or regional nodal recurrence or distant disease relapse		Documented evidence of local progression or regional nodal recurrence or distant disease relapse

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: W. Robert Lee, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Lee W, Bae K, Lawton C, et al.: Biochemical recurrence and late toxicity following external beam radiotherapy combined with permanent source prostate brachytherapy: analysis of RTOG 0019. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-100, S57, 2006.
Lee W, Bae K, Lawton CF, et al.: A descriptive analysis of postimplant dosimetric parameters from RTOG P0019. [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-83, 2006.
Lee WR, DeSilvio M, Lawton C, Gillin M, Morton G, Firat S, Baikadi M, Kuettel M, Greven K, Sandler H. A phase II study of external beam radiotherapy combined with permanent source brachytherapy for intermediate-risk, clinically localized adenocarcinoma of the prostate: preliminary results of RTOG P-0019. Int J Radiat Oncol Biol Phys. 2006 Mar 1;64(3):804-9. doi: 10.1016/j.ijrobp.2005.09.002. Epub 2005 Nov 14.
Lee W, DeSilvio M, Lawton C, et al.: Is postimplant dosimetry associated with late morbidity? A secondary analysis of RTOG P-0019. [Abstract] American Society of Clinical Oncology 2005 Prostate Cancer Symposium, 17-19 February 2005, Orlando, Florida. A-96, 2005.
Lee WR, Bae K, Lawton CA, Gillin MT, Morton G, Firat S, Baikadi M, Kuettel M, Greven K, Sandler H. A descriptive analysis of postimplant dosimetric parameters from Radiation Therapy Oncology Group P0019. Brachytherapy. 2006 Oct-Dec;5(4):239-43. doi: 10.1016/j.brachy.2006.08.005.
Lawton CA, Yan Y, Lee WR, Gillin M, Firat S, Baikadi M, Crook J, Kuettel M, Morton G, Sandler H. Long-term results of an RTOG Phase II trial (00-19) of external-beam radiation therapy combined with permanent source brachytherapy for intermediate-risk clinically localized adenocarcinoma of the prostate. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):e795-801. doi: 10.1016/j.ijrobp.2011.11.040. Epub 2012 Feb 11.
Lee WR, Bae K, Lawton C, Gillin M, Morton G, Firat S, Baikadi M, Kuettel M, Greven K, Sandler H. Late toxicity and biochemical recurrence after external-beam radiotherapy combined with permanent-source prostate brachytherapy: analysis of Radiation Therapy Oncology Group study 0019. Cancer. 2007 Apr 15;109(8):1506-12. doi: 10.1002/cncr.22560.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2000

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

October 4, 2000

First Submitted That Met QC Criteria

February 25, 2004

First Posted (Estimate)

February 26, 2004

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

RTOG-P-0019
CDR0000068238

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

External-Beam Radiation Therapy Plus Implanted Radiation Therapy in Treating Patients With Prostate Cancer

A Phase II Study of External Beam Radiation Therapy Combined With Permanent Source Brachytherapy for Intermediate Risk Clinically Localized Adenocarcinoma of the Prostate

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers