AzTrials
AzTrials

Prostate CancerPhase 2NCT00006365

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

A Phase 2 study testing brachytherapy, iodine I 125 and radiation therapy in people with Prostate Cancer, run by Radiation Therapy Oncology Group at 254 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
brachytherapy, iodine I 125 and radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
254 sitesin 2 countries
Study dates
Nov 2000to Nov 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

254 sites in 2 countries.

254 sites in 2 countries

United States236 sites

  • Akron General Medical Center

    Akron, Ohio, 44302

  • Akron City Hospital

    Akron, Ohio, 44309

  • Cancer Center of Albany Medical Center

    Albany, New York, 12208

  • Saint Joseph Medical Center

    Albuquerque, New Mexico, 87102

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Harrington Cancer Center

    Amarillo, Texas, 79106

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • St. John's Medical Center

    Anderson, Indiana, 46016

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0752

  • Anne Arundel Oncology Center

    Annapolis, Maryland, 21401

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342-1701

  • Greater Baltimore Medical Center and Cancer Center

    Baltimore, Maryland, 21204

  • Harbor Hospital Center

    Baltimore, Maryland, 21225

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21225

  • Johns Hopkins Oncology Center

    Baltimore, Maryland, 21231-2410

  • Radiation Oncology Affiliates of Maryland, P.A.

    Baltimore, Maryland, 21237

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Julie and Ben Rogers Cancer Institute

    Beaumont, Texas, 77701

  • CCOP - Southwestern Vermont Regional Cancer Center

    Bennington, Vermont, 05201

  • St. Luke's Hospital Regional Cancer Center

    Bethlehem, Pennsylvania, 18015

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • Bloomington Hospital

    Bloomington, Indiana, 47402

  • State University of New York Health Science Center at Brooklyn

    Brooklyn, New York, 11203

  • New York Methodist Hospital

    Brooklyn, New York, 11215-3609

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Vermont Cancer Center

    Burlington, Vermont, 05401-3498

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • Martha Jefferson Hospital

    Charlottesville, Virginia, 22901

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Barrett Cancer Center, The University Hospital

    Cincinnati, Ohio, 45219

  • Christ Hospital

    Cincinnati, Ohio, 45219

  • Lykes Center for Radiation Therapy

    Clearwater, Florida, 33757-0210

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Finger Lakes Radiation Oncology, P.C.

    Clifton Springs, New York, 14432

  • Memorial Hospital Cancer Center

    Colorado Springs, Colorado, 80909

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri, 65203

  • Medical Center/John B. Amos Community Cancer Center

    Columbus, Georgia, 31902

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210-1240

  • Mount Diablo Medical Center

    Concord, California, 94524-4110

  • Northeast Medical Center

    Concord, North Carolina, 28025

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Fitzgerald Mercy Hospital

    Darby, Pennsylvania, 19023

  • Halifax Medical Center

    Daytona Beach, Florida, 32114

  • CCOP - Central Illinois

    Decatur, Illinois, 62526

  • University of Colorado Cancer Center

    Denver, Colorado, 80010

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • Cancer Center and Beckman Research Institute, City of Hope

    Duarte, California, 91010-3000

  • Wendt Regional Cancer Center of Finley Hospital

    Dubuque, Iowa, 52001

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07018-1095

  • Pocono Cancer Center

    East Stroudsburg, Pennsylvania, 18301

  • John F. Kennedy Medical Center

    Edison, New Jersey, 08818

  • Provena St. Joseph Hospital- Regional Cancer Care Center

    Elgin, Illinois, 60123

  • Trinitas Hospital - Jersey Street Campus

    Elizabeth, New Jersey, 07201

  • Meritcare Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • McLaren Regional Cancer Center

    Flint, Michigan, 48432

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Radiation Therapy Associates - Fort Myers

    Fort Myers, Florida, 33901

  • California Cancer Center

    Fresno, California, 93720

  • Saint Agnes Cancer Center

    Fresno, California, 93720

  • University of Florida Health Science Center

    Gainesville, Florida, 32610-0296

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0209

  • Glendale Memorial Hospital and Health Center

    Glendale, California, 91204

  • Saint Mary's Hospital and Medical Center

    Grand Junction, Colorado, 81502

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54307-3508

  • Sutter Health West Cancer Research Group

    Greenbrae, California, 94904

  • East Carolina University School of Medicine

    Greenville, North Carolina, 27858-4354

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • RMH Regional Canter Center

    Harrisonburg, Virginia, 22801

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Penn State Geisinger Cancer Center

    Hershey, Pennsylvania, 17033

  • Catawba Memorial Hospital

    Hickory, North Carolina, 28601

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Huntsville Hospital System

    Huntsville, Alabama, 35801-4470

  • Comprehensive Cancer Institute of Huntsville

    Huntsville, Alabama, 35801

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Veterans Affairs Medical Center - Indianapolis (Roudebush)

    Indianapolis, Indiana, 46202

  • Clarion Health Partners Inc.

    Indianapolis, Indiana, 46206-1367

  • Community Hospitals of Indianapolis - Regional Cancer Center

    Indianapolis, Indiana, 46219

  • Holden Comprehensive Cancer Center at The University of Iowa

    Iowa City, Iowa, 52242-1009

  • Jackson-Madison County General Hospital

    Jackson, Tennessee, 38301

  • Veterans Affairs Medical Center - Boston (Jamaica Plain)

    Jamaica Plain, Massachusetts, 02130

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • CCOP - Dayton

    Kettering, Ohio, 45429

  • Gundersen Lutheran Medical Foundation

    La Crosse, Wisconsin, 54601

  • University of California San Diego Cancer Center

    La Jolla, California, 92093-0658

  • Wilford Hall - 59th Medical Wing

    Lackland Air Force Base, Texas, 78236-5300

  • Romagosa Radiation Oncology Center

    Lafayette, Louisiana, 70501

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756-0002

  • Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Veterans Affairs Medical Center - Lexington

    Lexington, Kentucky, 40511-1093

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0084

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Veterans Affairs Medical Center - Long Beach

    Long Beach, California, 90822

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740-6395

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033-0804

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • Louisville Radiation Oncology

    Louisville, Kentucky, 40215

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410-1894

  • Southern Wisconsin Radiotherapy Center

    Madison, Wisconsin, 53713

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Merle M. Mahr Cancer Center

    Madisonville, Kentucky, 42431

  • Elliot Regional Cancer Center

    Manchester, New Hampshire, 03103

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • Marquette General Hospital

    Marquette, Michigan, 49855

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Health First Holmes Regional Medical Center

    Melbourne, Florida, 32901

  • University of Tennessee, Memphis Cancer Center

    Memphis, Tennessee, 38103

  • Community Memorial Hospital

    Menomonee Falls, Wisconsin, 53051

  • Veterans Affairs Medical Center - Miami

    Miami, Florida, 33125

  • Sylvester Cancer Center, University of Miami

    Miami, Florida, 33136

  • Baptist Hospital of Miami

    Miami, Florida, 33176-2197

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • MidMichigan Medical Center - Midland

    Midland, Michigan, 48670

  • South Jersey Regional Cancer Center

    Millville, New Jersey, 08332

  • St. Joseph's Hospital

    Milwaukee, Wisconsin, 53210

  • Columbia Hospital

    Milwaukee, Wisconsin, 53211

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Veterans Affairs Medical Center - Milwaukee (Zablocki)

    Milwaukee, Wisconsin, 53295

  • Trinity Cancer Care Center

    Minot, North Dakota, 58701

  • MBCCOP - Gulf Coast

    Mobile, Alabama, 36688

  • Alabama Oncology, LLC

    Montgomery, Alabama, 36106-2801

  • Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County

    Mount Holly, New Jersey, 08060

  • Ball Memorial Hospital

    Muncie, Indiana, 47303-3499

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • Beth Israel Medical Center

    New York, New York, 10003

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609-3305

  • St. Anthony Hospital

    Oklahoma City, Oklahoma, 73101

  • Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Health System

    Omaha, Nebraska, 68105-1018

  • Methodist Cancer Center - Omaha

    Omaha, Nebraska, 68114

  • Florida Radiation Oncology Group

    Orange Park, Florida, 32073

  • MD Anderson Cancer Center Orlando

    Orlando, Florida, 32806

  • Bay Medical Center

    Panama City, Florida, 32401

  • Gulf Coast Cancer Treatment Center

    Panama City, Florida, 32405-4587

  • Lutheran General Cancer Care Center

    Park Ridge, Illinois, 60068

  • Huntington Cancer Center

    Pasadena, California, 91105

  • Bayshore Medical Center

    Pasadena, Texas, 77504

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • Hahnemann University Hospital

    Philadelphia, Pennsylvania, 19102-1192

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104-4283

  • Veterans Affairs Medical Center - Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213-3489

  • Mercy Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15219

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Champlain Valley Physicians Hospital Medical Center

    Plattsburgh, New York, 12901

  • Cancer Care Center

    Pomona, California, 91767

  • Atlantic City Medical Center

    Pomona, New Jersey, 08240

  • Maine Medical Center

    Portland, Maine, 04102

  • CCOP - Columbia River Program

    Portland, Oregon, 97213

  • Naval Medical Center, Portsmouth

    Portsmouth, Virginia, 23708-2197

  • Vassar Brothers Hospital

    Poughkeepsie, New York, 12601

  • Roger Williams Medical Center/BUSM

    Providence, Rhode Island, 02908-4735

  • Southeastern Wisconsin Regional Cancer Center

    Racine, Wisconsin, 53405

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57709

  • Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Bon-Secours - St. Mary's Hospital

    Richmond, Virginia, 23226

  • Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Valley Hospital

    Ridgewood, New Jersey, 07450

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • University of Rochester Cancer Center

    Rochester, New York, 14642

  • InterCommunity Cancer Center at Rome

    Rome, Georgia, 30161

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Radiation Oncology Center - Sacramento

    Sacramento, California, 95816

  • St. Mary's Medical Center

    Saginaw, Michigan, 48601

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Peninsula Regional Medical Center

    Salisbury, Maryland, 21801

  • University of Utah Health Sciences Center

    Salt Lake City, Utah, 84132

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Radiation Medical Group, Inc.

    San Diego, California, 92101-1492

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California, 94143-0128

  • O'Connor Hospital

    San Jose, California, 95128

  • CCOP - Santa Rosa Memorial Hospital

    Santa Rosa, California, 95403

  • Sarasota Radiation and Medical Oncology Center

    Sarasota, Florida, 34233

  • Mercy Hospital Cancer Center - Scranton

    Scranton, Pennsylvania, 18501

  • Virginia Mason Medical Center

    Seattle, Washington, 98111

  • Grand View Hospital

    Sellersville, Pennsylvania, 18960

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Deaconess Medical Center

    Spokane, Washington, 99210-0248

  • Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • St. Louis University Health Sciences Center

    St Louis, Missouri, 63110-0250

  • Mallinckrodt Institute of Radiology

    St Louis, Missouri, 63110

  • Dixie Regional Medical Center

    St. George, Utah, 84770

  • Tallahassee Memorial Healthcare

    Tallahassee, Florida, 32308

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • Albert Einstein Comprehensive Cancer Center

    The Bronx, New York, 10461

  • CCOP - Toledo Community Hospital Oncology Program

    Toledo, Ohio, 43623-3456

  • Community Medical Center

    Toms River, New Jersey, 08755

  • David Grant Medical Center

    Travis Air Force Base, California, 94535

  • St. Francis Medical Center

    Trenton, New Jersey, 08629

  • William Beaumont Hospital - Troy

    Troy, Michigan, 48098

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • St. John Health System

    Tulsa, Oklahoma, 74104

  • North Mississippi Medical Center/Cancer Center

    Tupelo, Mississippi, 38801

  • Radiation Oncology Associates of West Alabama

    Tuscaloosa, Alabama, 35401

  • East Texas Medical Center - Cancer Institute

    Tyler, Texas, 75701

  • New York Medical College

    Valhalla, New York, 10595

  • Associated Radiologists, P.A.

    Warren Township, New Jersey, 07059

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000

  • Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • Schiffler Cancer Center

    Wheeling, West Virginia, 26003

  • Wilkes Barre General Hospital

    Wilkes-Barre, Pennsylvania, 18764

  • CCOP - Christiana Care Health Services

    Wilmington, Delaware, 19899

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • Bowman Gray School of Medicine

    Winston-Salem, North Carolina, 27157

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

  • Yakima Valley Memorial Hospital

    Yakima, Washington, 98902

  • Riverhill Radiation Oncology

    Yonkers, New York, 10701

  • York Hospital

    York, Pennsylvania, 17315

Other trials in United States

Canada18 sites

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • CHUS-Hopital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • Northeastern Ontario Regional Cancer Centre, Sudbury

    Greater Sudbury, Ontario, P3E 5J1

  • Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Cancer Care Ontario-Hamilton Regional Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Kingston Regional Cancer Centre

    Kingston, Ontario, K7L 5P9

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • McGill University

    Montreal, Quebec, H2W 1S6

  • Ottawa Regional Cancer Centre - General Campus

    Ottawa, Ontario, K1H 1C4

  • CHU de Quebec - L'Hotel-Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Newfoundland Cancer Treatment and Research Foundation

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Northwestern Ontario Regional Cancer Centre, Thunder Bay

    Thunder Bay, Ontario, P7A 7T1

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions
Prostate Cancer
Being tested
brachytherapy, iodine I 125, radiation therapy
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • brachytherapyRadiation

  • iodine I 125Radiation

  • radiation therapyRadiation

Study groups in NCT00006365
Study groupRoleWhat they receive
EBRT to the prostate followed by brachytherapyExperimentalPatients 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.
Receives: Radiation: brachytherapy; Radiation: iodine I 125; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of late severe GU and GI toxicity

    Rate of late severe GU and GI toxicity defined as grade 3-5 GU and GI toxicity based on Common Toxicity Criteria 2.0

    Measured: Start of radiotherapy to at least 18 months of follow-up

Secondary outcomes (4)

  1. Rate of acute severe GU and GI toxicity

    Rate of acute severe GU and GI toxicity, defined as grde 3-5 GU and GI toxicity based on Common Toxicity Criteria 2.0

    Measured: Nine months from the start of radiotherapy

  2. Biochemical Failure

    Measured: 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

  3. Overall failure

    Measured: From the date of study entry to the date of death due to any cause

  4. Failure rate of clinical progression including local-regional/distant failure

    Measured: Documented evidence of local progression or regional nodal recurrence or distant disease relapse

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2004 (estimated)
  2. Study startNov 2000
  3. Primary completionDec 2006
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006365
Sponsor's protocol ID
RTOG-P-0019
Other IDs
CDR0000068238
Status last verified
Jan 2014
First submitted
4 Oct 2000
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 16289906

  • 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.

    PubMed 17118317

  • 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.

    PubMed 22330999

  • 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.

    PubMed 17340591

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing brachytherapy, iodine I 125 and radiation therapy in people with Prostate Cancer, run by Radiation Therapy Oncology Group at 254 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 254 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of late severe GU and GI toxicity (time frame: Start of radiotherapy to at least 18 months of follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006365, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

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