Brachytherapy in Treating Patients With Prostate Cancer

January 23, 2014 updated by: Radiation Therapy Oncology Group

Phase II Trial of Transrectal Ultrasound Guided Permanent Radioactive Implantation of the Prostate for Definitive Management of Localized Adenocarcinoma of the Prostate

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy through seeds implanted into the prostate may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of brachytherapy in treating patients with stage I or stage II prostate cancer.

Study Overview

Status

Completed

Conditions

Prostate Cancer

Intervention / Treatment

Radiation: iodine I 125

Detailed Description

OBJECTIVES: I. Evaluate the effectiveness of transrectal ultrasound guided permanent radioactive implantation of the prostate in patients with confined adenocarcinoma of the prostate. II. Assess the overall survival, disease specific survival, clinical relapse (local or distant), PSA levels, and genitourinary and gastrointestinal morbidity in these implant patients. III. Assess the quality of life of these patients.

OUTLINE: This is a multicenter study. Patients receive transrectal ultrasound guided radioactive I-125 seeds implanted into the prostate. At least one week prior to implant, patients undergo transurethral ultrasound study to determine the volume of prostate. Following implantation, seeds that have extruded into the bladder or lodged in the urethral wall are retrieved, and extra seeds may be implanted into identified "cold spots" for uniform seed distribution. Prostate rebiopsy is required before starting hormonal therapy for local progression or biochemical failure without clear focus of progression. Quality of life is assessed every 3 months for 1 year, then every 6 months for 1 year, and then annually for 3 years. Patients are followed every 3 months for 1 year, then every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 95 patients will be accrued for this study within 1 year.

Study Type

Interventional

Enrollment (Anticipated)

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
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Cancer Institute
- British Columbia
  - Victoria, British Columbia, Canada, V8R 1J8
    - British Columbia Cancer Agency - Vancouver Island Cancer Centre
- New Brunswick
  - Moncton, New Brunswick, Canada, E1C 8X3
    - Doctor Leon Richard Oncology Centre
  - Saint John, New Brunswick, Canada, E2L 4L2
    - Saint John Regional Hospital
- 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, K1Y 4K7
    - Ottawa Regional Cancer Centre - Civic 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
  - Montreal, Quebec, Canada, H2W 1S6
    - McGill University Department of Oncology
  - Montreal, Quebec, Canada, H2W-W1T8
    - Centre Hospitalier de l'Université de Montréal
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N 4H4
    - Saskatoon Cancer Centre
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - Veterans Affairs Medical Center - Birmingham
  - Birmingham, Alabama, United States, 35294
    - University of Alabama Comprehensive Cancer Center
  - Huntsville, Alabama, United States, 35801
    - Huntsville Hospital System
  - Mobile, Alabama, United States, 36688
    - MBCCOP - University of South Alabama
  - Mobile, Alabama, United States, 36640
    - Urology Associates - Mobile AL
  - Montgomery, Alabama, United States, 36106-2801
    - Alabama Oncology, LLC
  - Tuscallosa, Alabama, United States, 35401
    - Radiation Oncology Associates of West Alabama
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Providence Cancer Therapy Center
- Arizona
  - Phoenix, Arizona, United States, 85001-2071
    - St. Joseph's Hospital and Medical Center
  - Tucson, Arizona, United States, 85724
    - Arizona Cancer Center
- California
  - Burbank, California, United States, 91505
    - Providence Saint Joseph Medical Center - Burbank
  - Concord, California, United States, 94524-4110
    - Mount Diablo Medical Center
  - Duarte, California, United States, 91010
    - 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 Western Division Cancer Research Group
  - 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, 90033-0800
    - USC/Norris Comprehensive Cancer Center
  - Los Angeles, California, United States, 90095-1781
    - Jonsson Comprehensive Cancer Center, UCLA
  - Los Angeles, California, United States, 90027
    - Kaiser Permanente Medical Center - Los Angeles
  - Martinez, California, United States, 94553
    - Veterans Affairs Outpatient Clinic - Martinez
  - Oakland, California, United States, 94609-3305
    - CCOP - Bay Area Tumor Institute
  - Pomona, California, United States, 91767
    - Cancer Care Center
  - Redding, California, United States, 96099-6009
    - Mercy Medical Center - Redding
  - Sacramento, California, United States, 95816
    - Radiation Oncology Center - Sacramento
  - San Francisco, California, United States, 94115-0128
    - UCSF Cancer Center and Cancer Research Institute
  - San Jose, California, United States, 95128
    - O'Connor Hospital
  - Santa Cruz, California, United States, 95065
    - Santa Cruz Radiation Oncology Medical Group, Inc.
  - Santa Rosa, California, United States, 95403
    - CCOP - Santa Rosa Memorial Hospital
  - Stanford, California, United States, 94305
    - Stanford University
  - Travis Air Force Base, California, United States, 94535
    - David Grant Medical Center
  - Walnut Creek, California, United States, 94598
    - Radiation Oncology Center - Walnut Creek
- Colorado
  - Colorado Springs, Colorado, United States, 80909
    - Memorial Hospital Cancer Center
  - Denver, Colorado, United States, 80262
    - University of Colorado Cancer Center
- Connecticut
  - Bridgeport, Connecticut, United States, 06610
    - Bridgeport Hospital
  - Norwalk, Connecticut, United States, 06856
    - Whittingham Cancer 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 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
  - Pensacola, Florida, United States, 32514
    - West Florida Cancer Institute - Pensacola
  - Saint Petersburg, Florida, United States, 33701
    - Bayfront Medical Center
  - Sarasota, Florida, United States, 34233
    - Sarasota Radiation and Medical Oncology Center
  - Tampa, Florida, United States, 33612
    - 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
  - Valdosta, Georgia, United States, 31603
    - South Georgia Medical Center
- Illinois
  - Arlington Heights, Illinois, United States, 60005
    - Northwest Community Hospital
  - Chicago, Illinois, United States, 60611
    - Northwestern Memorial Hospital
  - Chicago, Illinois, United States, 60637
    - University of Chicago Cancer Research 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
  - Springfield, Illinois, United States, 62526
    - CCOP - Central Illinois
  - Urbana, Illinois, United States, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Anderson, Indiana, United States, 46016
    - St. John's Medical Center
  - 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
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46617
    - St. Joseph's Radiation Oncology Center
- Iowa
  - Dubuque, Iowa, United States, 52001
    - Wendt Regional Cancer Center of Finley Hospital
  - Iowa City, Iowa, United States, 52242
    - University of Iowa Hospitals and Clinics
- Kentucky
  - Bowling Green, Kentucky, United States, 42102
    - Medical Center at Bowling Green
  - 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
  - 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
  - Paducah, Kentucky, United States, 42001
    - Western Baptist Hospital
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Mary Bird Perkins Cancer Center
  - Lafayette, Louisiana, United States, 70501
    - Romagosa Radiation Oncology Center
  - Metairie, Louisiana, United States, 70011
    - East Jefferson General Hospital
  - New Orleans, Louisiana, United States, 70112
    - Tulane University School of Medicine
  - New Orleans, Louisiana, United States, 70112
    - MBCCOP - LSU Medical Center
  - New Orleans, Louisiana, United States, 70121
    - CCOP - Ochsner
- Maine
  - Portland, Maine, United States, 04102
    - Maine Medical Center
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Anne Arundel Oncology Center
  - Baltimore, Maryland, United States, 21201
    - Marlene & Stewart Greenebaum Cancer Center, University of Maryland
  - 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, 21287
    - Johns Hopkins Oncology Center
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital Cancer Center
  - Boston, Massachusetts, United States, 02215
    - Joint Center for Radiation Therapy
  - 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, 48105
    - Veterans Affairs Medical Center - Ann Arbor
  - Ann Arbor, Michigan, United States, 48106
    - CCOP - Ann Arbor Regional
  - Detroit, Michigan, United States, 48201
    - Barbara Ann Karmanos Cancer Institute
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
  - 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
  - Lansing, Michigan, United States, 48909
    - Sparrow Regional Cancer Center
  - Marquette, Michigan, United States, 49855
    - Marquette General Hospital
  - Midland, Michigan, United States, 48670
    - MidMichigan Regional Medical Center
  - Saginaw, Michigan, United States, 48601
    - St. Mary's Medical Center
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic Cancer Center
  - Saint Louis Park, Minnesota, United States, 55416
    - CCOP - Metro-Minnesota
- 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, 63106
    - Veterans Affairs Medical Center - Saint Louis
  - Saint Louis, Missouri, United States, 63110
    - Mallinckrodt Institute of Radiology
  - Springfield, Missouri, United States, 65807
    - CCOP - 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, 68131
    - CCOP - Missouri Valley Cancer Consortium
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - CCOP - Southern Nevada Cancer Research Foundation
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - 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
    - Elizabeth General Medical Center - West
  - Millville, New Jersey, United States, 08332
    - South Jersey Hospital - Millville
  - Mount Holly, New Jersey, United States, 08060
    - Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
  - Newark, New Jersey, United States, 07112
    - Newark Beth Israel Medical Center
  - Toms River, New Jersey, United States, 08755
    - Community Medical Center
  - Trenton, New Jersey, United States, 08629
    - St. Francis Medical Center
- 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
  - Albany, New York, United States, 12208
    - Veterans Affairs Medical Center - Albany
  - 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, 10016
    - Kaplan 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, 14607
    - Genesee Hospital - Rochester
  - Rochester, New York, United States, 14642
    - University of Rochester Cancer Center
  - Valhalla, New York, United States, 10595
    - New York Medical College
- 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 of Wake Forest University Baptist Medical Center
- North Dakota
  - Fargo, North Dakota, United States, 58122
    - Meritcare Roger Maris Cancer Center
  - Minot, North Dakota, United States, 58701
    - UNI-MED Medical Center
- Ohio
  - Akron, Ohio, United States, 44302
    - Akron General Medical Center
  - Akron, Ohio, United States, 44309
    - Akron City 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, 43206
    - CCOP - Columbus
  - Columbus, Ohio, United States, 43210
    - Arthur G. James Cancer Hospital - Ohio State University
  - Dayton, Ohio, United States, 45428
    - Veterans Affairs Medical Center - Dayton
  - Kettering, Ohio, United States, 45429
    - CCOP - Dayton
  - Toledo, Ohio, United States, 43623-3456
    - CCOP - Toledo Community Hospital Oncology Program
- Oklahoma
  - Tulsa, Oklahoma, United States, 74104
    - St. John Medical Center
- Oregon
  - Corvallis, Oregon, United States, 97339
    - Samaritan Regional Cancer Center
  - 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
    - Penn State Geisinger Medical Center
  - Darby, Pennsylvania, United States, 19023
    - Mercy Catholic Medical Center, Mercy Fitzgerald Divison
  - Drexel Hill, Pennsylvania, United States, 19026
    - Delaware County Memorial Hospital
  - Hershey, Pennsylvania, United States, 17033
    - Penn State Geisinger Cancer Center
  - Philadelphia, Pennsylvania, United States, 19111
    - Fox Chase Cancer Center
  - Philadelphia, Pennsylvania, United States, 19102-1192
    - Allegheny University Hospitals- Hahnemann
  - Philadelphia, Pennsylvania, United States, 19104
    - University of Pennsylvania Cancer Center
  - Philadelphia, Pennsylvania, United States, 19104
    - Veterans Affairs Medical Center - Philadelphia
  - Philadelphia, Pennsylvania, United States, 19107
    - Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
  - Philadelphia, Pennsylvania, United States, 19141
    - Albert Einstein Cancer Center
  - Pittsburgh, Pennsylvania, United States, 15224
    - Western Pennsylvania Hospital
  - Pittsburgh, Pennsylvania, United States, 15213
    - 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
- Tennessee
  - Jackson, Tennessee, United States, 38301
    - Jackson-Madison County General Hospital
  - Knoxville, Tennessee, United States, 37901
    - Baptist Regional Cancer Center - Knoxville
  - Memphis, Tennessee, United States, 38117
    - CCOP - Baptist Cancer Institute
  - Memphis, Tennessee, United States, 38163
    - University of Tennessee, Memphis Cancer Center
  - Nashville, Tennessee, United States, 37232-6838
    - Vanderbilt 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, 77555-1329
    - University of Texas Medical Branch
  - Houston, Texas, United States, 77030
    - 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, 84143
    - LDS Hospital
- Vermont
  - Bennington, Vermont, United States, 05201
    - CCOP - Southwestern Vermont Regional Cancer Center
  - Burlington, Vermont, United States, 05401-3498
    - Vermont Cancer Center
  - Rutland, Vermont, United States, 05701
    - Green Mountain Oncology Group
  - White River Junction, Vermont, United States, 05009
    - Veterans Affairs Medical Center - White River Junction
- Virginia
  - Charlottesville, Virginia, United States, 22901
    - Martha Jefferson Hospital
  - Charlottesville, Virginia, United States, 22908
    - Cancer Center, University of Virginia HSC
  - Lynchburg, Virginia, United States, 24503
    - Virginia Baptist Hospital
  - Portsmouth, Virginia, United States, 23708-2197
    - Naval Medical Center, Portsmouth
  - Richmond, Virginia, United States, 23298-0037
    - Massey Cancer Center
- Washington
  - Seattle, Washington, United States, 98104
    - Swedish Cancer Institute
  - 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 Oncology 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, 53705
    - Veterans Affairs Medical Center - Madison
  - Madison, Wisconsin, United States, 53792
    - 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, 53226
    - Medical College of Wisconsin
  - 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

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS: Histologically proven locally confined adenocarcinoma of the prostate Stage I or II (T1b-c or T2a-b, NX, M0) PSA no greater than 10 ng/mL Prostate volume by transurethral ultrasound no greater than 45/mm3 at least 1 week, but no more than 4 weeks, prior to implant Gleason score no greater than 6 American Urological Association voiding symptom score no greater than 12 No evidence of distant metastases No lymph node involvement

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No prior or concurrent malignancy within 5 years except basal or squamous cell skin cancer No major medical or psychiatric illness

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No prior hormonal therapy, including finasteride Radiotherapy: No prior pelvic radiotherapy Surgery: No prior radical surgery for prostate cancer (e.g., transurethral prostatectomy) No hip prosthesis

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

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: Colleen A. Lawton, MD, Medical College of Wisconsin

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

Gillin MT, Dunning BF, Lawton CA, Foley WD, Byhardt RW, Morton G, Baikadi M, Pisansky TT, Michalski JM, Ibbott G, Lopez F; Radiation Therapy Oncology Group. Quality assurance methods for the first Radiation Therapy Oncology Group permanent prostate implant protocol. Brachytherapy. 2006 Jul-Sep;5(3):152-6. doi: 10.1016/j.brachy.2006.05.004.
Lawton CA, Hunt D, Lee WR, Gomella L, Grignon D, Gillin M, Morton G, Pisansky TM, Sandler H. Long-term results of a phase II trial of ultrasound-guided radioactive implantation of the prostate for definitive management of localized adenocarcinoma of the prostate (RTOG 98-05). Int J Radiat Oncol Biol Phys. 2011 Sep 1;81(1):1-7. doi: 10.1016/j.ijrobp.2010.05.056. Epub 2011 Apr 4.
Lawton CA, DeSilvio M, Lee WR, Gomella L, Grignon D, Gillin M, Morton G, Pisansky T, Sandler H. Results of a phase II trial of transrectal ultrasound-guided permanent radioactive implantation of the prostate for definitive management of localized adenocarcinoma of the prostate (radiation therapy oncology group 98-05). Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):39-47. doi: 10.1016/j.ijrobp.2006.08.016. Epub 2006 Nov 2.
Feigenberg SJ, Lee WR, Desilvio ML, Winter K, Pisansky TM, Bruner DW, Lawton C, Morton G, Baikadi M, Sandler H. Health-related quality of life in men receiving prostate brachytherapy on RTOG 98-05. Int J Radiat Oncol Biol Phys. 2005 Jul 15;62(4):956-64. doi: 10.1016/j.ijrobp.2004.12.061.
Lawton CA, DeSilvio M, Lee WR, et al.: Correlating prostate seed implant quality with clinical outcomes for patients treated on RTOG protocol 98-05 (a multi-institutional phase II trial of transrectal ultrasound guided prostate seed implant for localized prostate cancer). [Abstract] American Society of Clinical Oncology 2005 Prostate Cancer Symposium, 17-19 February 2005, Orlando, Florida. A-90, 2005.

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

September 1, 1998

Primary Completion (Actual)

January 1, 2004

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

August 13, 2004

First Posted (Estimate)

August 16, 2004

Study Record Updates

Last Update Posted (Estimate)

January 24, 2014

Last Update Submitted That Met QC Criteria

January 23, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

RTOG-9805
CDR0000066259

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.

Clinical Trials on Prostate Cancer

Roswell Park Cancer Institute

Recruiting

Nutrition and Exercise Interventions in Reducing Androgen Deprivation Therapy-Induced Obese Frailty in Prostate Cancer Survivors

Obesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditions

United States
Sidney Kimmel Cancer Center at Thomas Jefferson...
Regeneron Pharmaceuticals; Prostate Cancer Foundation

Withdrawn

Stereotactic Body Radiation Therapy With REGN2810 and/or Ipilimumab Before Surgery in Treating Participants With Progressive Advanced or Oligometastatic Prostate Cancer

Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)

Completed

Effect of Quercetin on Green Tea Polyphenol Uptake in Prostate Tissue From Patients With Prostate Cancer Undergoing Surgery

Recurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer

United States
University of Southern California
National Cancer Institute (NCI); Sanofi

Terminated

Cabazitaxel Plus Prednisone With Octreotide For Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel

Diarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer

United States
Ryan Kohlbrenner, MD
Radiological Society of North America

Completed

Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion

Prostate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...

United States
Jonsson Comprehensive Cancer Center
Progenics Pharmaceuticals, Inc.

Terminated

Randomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)

Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...

United States
Ohio State University Comprehensive Cancer Center
Riverside Methodist Hospital

Completed

Tangerine or Red Tomato Juice in Treating Patients With Prostate Cancer Undergoing Surgery

Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer

United States
University of California, Irvine

Completed

Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Naïve Prostate Cancer Patients

Recurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer

United States
Mayo Clinic
National Cancer Institute (NCI)

Withdrawn

Daily, Long-Term Intermittent Fasting for the Prevention of PSA-Recurrence in Patients With Localized Prostate Cancer After Radical Prostatectomy

Stage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...

United States
NRG Oncology
National Cancer Institute (NCI)

Recruiting

Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer

Prostate Adenocarcinoma | Stage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer... and other conditions

United States

Clinical Trials on iodine I 125

Radiation Therapy Oncology Group
National Cancer Institute (NCI)

Completed

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

Prostate Cancer

United States, Canada
National Cancer Institute (NCI)

Completed

Brachytherapy in Treating Patients With Recurrent Malignant Glioma

Brain and Central Nervous System Tumors

United States
New Approaches to Brain Tumor Therapy Consortium
National Cancer Institute (NCI)

Completed

Radiation Therapy in Treating Patients With Progressive or Recurrent Malignant Brain Tumors

Brain and Central Nervous System Tumors

United States
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)

Terminated

Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer

Lung Cancer

United States, Canada
Children's Oncology Group
National Cancer Institute (NCI)

Completed

Neoadjuvant Carboplatin and Vincristine and Standard Local Ophthalmic Therapy in Treating Patients With Intraocular Retinoblastoma

Intraocular Retinoblastoma

United States
Translational Research Center for Medical Innovation...
The Jikei University School of Medicine

Completed

Luteinizing Hormone-Releasing Hormone Agonist Therapy and Iodine I 125 Implant in Treating Patients With Previously Untreated Prostate Cancer (SHIP0804)

Prostate Cancer

Japan
British Columbia Cancer Agency
Biocompatibles UK Ltd

Completed

Ability of a New Design of Iodine 125 Seed to Maintain Intended Position When Implanted in the Prostate (FAST)

Prostate Cancer

Canada
Xuzhou Central Hospital

Enrolling by invitation

I-125 Seeds Loaded Stent Insertion for Inoperable Hilar Cholangiocarcinoma

Hilar Cholangiocarcinoma

China
Jiangxi Provincial Cancer Hospital

Completed

Clinical Efficacy of 125I Seed Implantation in the Treatment of Refractory Differentiated Thyroid Cancer

Thyroid Neoplasms
Translational Research Center for Medical Innovation...
Kurosawa Hospital

Completed

Implant Radiation Therapy Using Radioactive Iodine in Treating Patients With Localized Prostate Cancer (J-POPS)

Prostate Cancer

Japan

Brachytherapy in Treating Patients With Prostate Cancer

Phase II Trial of Transrectal Ultrasound Guided Permanent Radioactive Implantation of the Prostate for Definitive Management of Localized Adenocarcinoma of the Prostate

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Anticipated)

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

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 (Estimate)

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

Clinical Trials on Prostate Cancer

Clinical Trials on iodine I 125

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Conditions

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