Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer

NCT ID: NCT00002597

Last Updated: 2018-06-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2028 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-10-31

Study Completion Date

2018-05-14

Brief Summary

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RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer.

Detailed Description

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OBJECTIVES: Primary: To evaluate whether a combination of Zoladex and flutamide used as cytoreductive agents prior to and during definitive radiation therapy improves overall survival over radiation therapy alone in locally confined carcinomas of the prostate; Secondary: To compare the rates of disease-specific survival, clinical relapse (local progression and/or distant failure), freedom from prostate-specific antigen (PSA) failure, freedom from second clinical relapse, freedom from second PSA relapse, and disease-free survival; To compare the prostate re-biopsy at two years; To measure the effect on sexual function.

OUTLINE: This is a randomized, multicenter study. Patients were stratified by PSA level (less than 4 vs 4-20), tumor differentiation (well vs moderate vs poor), nodal status (N0 \[nodes evaluated by surgical sampling\] vs NX \[nodes evaluated negative by imaging methods only\]), and participating center. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral flutamide 3 times a day and goserelin subcutaneously once every 4 weeks, or once as a time release injection (intramuscular leuprolide may be substituted for goserelin), beginning 2 months prior to radiotherapy and continuing until completion of radiotherapy. Patients undergo radiotherapy daily 4-5 days per week for almost 8 weeks. Arm II: Patients undergo radiotherapy only, as in arm I. Patients are followed every 3 months for the remainder of the first year, every 4 months for the second year, every 6 months for the third through fifth years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1980 patients within 5 years.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neoadjuvant TAS + RT

Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.

Group Type EXPERIMENTAL

flutamide

Intervention Type DRUG

Two 125 mg capsules (t.i.d., p.o.) beginning two months before RT and continuing until RT is completed.

Zoladex

Intervention Type DRUG

3.6 mg s.c. monthly x 4 beginning two months before RT and continuing until RT is completed. The 3-month preparation may be used instead of three separate monthly injections.

Lupron

Intervention Type DRUG

7.5 mg IM (intramuscular) monthly x 4 beginning two months before RT and continuing until RT is completed. The 3-month preparation may be used instead of three separate monthly injections.

radiation therapy

Intervention Type RADIATION

46.8 Gy (1.8 Gy/day four to five times a week \[26 fx\]) to regional lymphatics followed by 19.8 Gy (1.8 Gy/day x 11 fx) for a total of 66.6 Gy to the prostate. Prostate only may be treated in defined circumstances.

Radiation therapy alone

Radiation therapy alone

Group Type OTHER

radiation therapy

Intervention Type RADIATION

46.8 Gy (1.8 Gy/day four to five times a week \[26 fx\]) to regional lymphatics followed by 19.8 Gy (1.8 Gy/day x 11 fx) for a total of 66.6 Gy to the prostate. Prostate only may be treated in defined circumstances.

Interventions

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flutamide

Two 125 mg capsules (t.i.d., p.o.) beginning two months before RT and continuing until RT is completed.

Intervention Type DRUG

Zoladex

3.6 mg s.c. monthly x 4 beginning two months before RT and continuing until RT is completed. The 3-month preparation may be used instead of three separate monthly injections.

Intervention Type DRUG

Lupron

7.5 mg IM (intramuscular) monthly x 4 beginning two months before RT and continuing until RT is completed. The 3-month preparation may be used instead of three separate monthly injections.

Intervention Type DRUG

radiation therapy

46.8 Gy (1.8 Gy/day four to five times a week \[26 fx\]) to regional lymphatics followed by 19.8 Gy (1.8 Gy/day x 11 fx) for a total of 66.6 Gy to the prostate. Prostate only may be treated in defined circumstances.

Intervention Type RADIATION

Other Intervention Names

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Eulexin goserelin acetate leuprolide acetate

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed locally confined adenocarcinoma of the prostate with primary tumors confined to the prostate, clinical stage T1b,1c, 2a or 2b.
* Negative nodes evaluated by imaging methods (classified in the study as NX) or by surgical sampling (classified in the study as N0).
* Karnofsky performance status ≥ 70.
* PSA is mandatory, must be ≤ 20)
* No prior hormonal therapy, radiation or chemotherapy.
* Prior finasteride for prostate hypertrophy allowed if discontinued at least 60 days prior to randomization.
* Prior testosterone administration allowed if at least 90 days elapsed since last administration.
* No evidence of distant metastasis or other synchronous primary. Patients with prior invasive malignancy who were disease free for at least 5 years could be eligible with pre-randomization approval by the study chairman.
* Treatment begins within 21 days after randomization.
* Patients signs a study-specific informed consent form.
* Alanine Aminotransferase (ALT) within 2x upper normal limits.

Exclusion Criteria

* Stage T1a or ≥ T2c disease.
* Lymph node involvement (N1 - N3).
* Evidence of distant metastasis. (M1)
* PSA \> 20.
* Radical surgery or cryosurgery for carcinoma of the prostate, previous irradiation, antiandrogen therapy or chemotherapy.
* Previous or concurrent cancers other than basal cell or squamous cell skin carcinoma.

Patients with squamous cell carcinomas required to be NED (no evidence of disease) for a minimum of two years prior to study entry.

* Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
* Karnofsky performance status of \< 70.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David G. McGowan, MD

Role: STUDY_CHAIR

Cross Cancer Institute at University of Alberta

Locations

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University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

Site Status

Huntsville Hospital System

Huntsville, Alabama, United States

Site Status

Comprehensive Cancer Institute of Huntsville

Huntsville, Alabama, United States

Site Status

MBCCOP - Gulf Coast

Mobile, Alabama, United States

Site Status

Alabama Oncology, LLC

Montgomery, Alabama, United States

Site Status

Radiation Oncology Associates of West Alabama

Tuscaloosa, Alabama, United States

Site Status

Providence Alaska Medical Center

Anchorage, Alaska, United States

Site Status

Arizona Cancer Center

Tucson, Arizona, United States

Site Status

Mount Diablo Medical Center

Concord, California, United States

Site Status

Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, United States

Site Status

California Cancer Center

Fresno, California, United States

Site Status

Saint Agnes Cancer Center

Fresno, California, United States

Site Status

Glendale Memorial Hospital and Health Center

Glendale, California, United States

Site Status

Sutter Health Western Division Cancer Research Group

Greenbrae, California, United States

Site Status

University of California San Diego Cancer Center

La Jolla, California, United States

Site Status

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Veterans Affairs Medical Center - Long Beach

Long Beach, California, United States

Site Status

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Site Status

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Site Status

CCOP - Bay Area Tumor Institute

Oakland, California, United States

Site Status

Cancer Care Center

Pomona, California, United States

Site Status

Radiation Oncology Center - Sacramento

Sacramento, California, United States

Site Status

Radiation Medical Group, Inc.

San Diego, California, United States

Site Status

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, United States

Site Status

O'Connor Hospital

San Jose, California, United States

Site Status

CCOP - Santa Rosa Memorial Hospital

Santa Rosa, California, United States

Site Status

Memorial Hospital Cancer Center

Colorado Springs, Colorado, United States

Site Status

University of Colorado Cancer Center

Denver, Colorado, United States

Site Status

CCOP - Christiana Care Health Services

Wilmington, Delaware, United States

Site Status

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Site Status

Lykes Center for Radiation Therapy

Clearwater, Florida, United States

Site Status

Halifax Medical Center

Daytona Beach, Florida, United States

Site Status

Radiation Therapy Associates - Fort Myers

Fort Myers, Florida, United States

Site Status

University of Florida Health Science Center

Gainesville, Florida, United States

Site Status

Health First Holmes Regional Medical Center

Melbourne, Florida, United States

Site Status

dVeterans Affairs Medical Center - Miami

Miami, Florida, United States

Site Status

Sylvester Cancer Center, University of Miami

Miami, Florida, United States

Site Status

Baptist Hospital of Miami

Miami, Florida, United States

Site Status

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status

Florida Radiation Oncology Group

Orange Park, Florida, United States

Site Status

MD Anderson Cancer Center Orlando

Orlando, Florida, United States

Site Status

Bay Medical Center

Panama City, Florida, United States

Site Status

Gulf Coast Cancer Treatment Center

Panama City, Florida, United States

Site Status

Sarasota Radiation and Medical Oncology Center

Sarasota, Florida, United States

Site Status

Tallahassee Memorial Healthcare

Tallahassee, Florida, United States

Site Status

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Emory University Hospital - Atlanta

Atlanta, Georgia, United States

Site Status

CCOP - Atlanta Regional

Atlanta, Georgia, United States

Site Status

Medical Center/John B. Amos Community Cancer Center

Columbus, Georgia, United States

Site Status

InterCommunity Cancer Center at Rome

Rome, Georgia, United States

Site Status

Northwest Community Hospital

Arlington Heights, Illinois, United States

Site Status

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Site Status

CCOP - Central Illinois

Decatur, Illinois, United States

Site Status

Provena St. Joseph Hospital- Regional Cancer Care Center

Elgin, Illinois, United States

Site Status

Ingalls Memorial Hospital

Harvey, Illinois, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Lutheran General Cancer Care Center

Park Ridge, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

St. John's Medical Center

Anderson, Indiana, United States

Site Status

Veterans Affairs Medical Center - Indianapolis (Roudebush)

Indianapolis, Indiana, United States

Site Status

Clarion Health Partners Inc.

Indianapolis, Indiana, United States

Site Status

Community Hospitals of Indianapolis - Regional Cancer Center

Indianapolis, Indiana, United States

Site Status

Ball Memorial Hospital

Muncie, Indiana, United States

Site Status

Wendt Regional Cancer Center of Finley Hospital

Dubuque, Iowa, United States

Site Status

Holden Comprehensive Cancer Center at The University of Iowa

Iowa City, Iowa, United States

Site Status

Veterans Affairs Medical Center - Lexington

Lexington, Kentucky, United States

Site Status

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, United States

Site Status

James Graham Brown Cancer Center

Louisville, Kentucky, United States

Site Status

Louisville Radiation Oncology

Louisville, Kentucky, United States

Site Status

Merle M. Mahr Cancer Center

Madisonville, Kentucky, United States

Site Status

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Site Status

Romagosa Radiation Oncology Center

Lafayette, Louisiana, United States

Site Status

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, United States

Site Status

Tulane University School of Medicine

New Orleans, Louisiana, United States

Site Status

CCOP - Ochsner

New Orleans, Louisiana, United States

Site Status

Maine Medical Center

Portland, Maine, United States

Site Status

Anne Arundel Oncology Center

Annapolis, Maryland, United States

Site Status

Greater Baltimore Medical Center and Cancer Center

Baltimore, Maryland, United States

Site Status

Harbor Hospital Center

Baltimore, Maryland, United States

Site Status

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Site Status

Johns Hopkins Oncology Center

Baltimore, Maryland, United States

Site Status

Radiation Oncology Affiliates of Maryland, P.A.

Baltimore, Maryland, United States

Site Status

Peninsula Regional Medical Center

Salisbury, Maryland, United States

Site Status

Cape Cod Hospital

Hyannis, Massachusetts, United States

Site Status

Veterans Affairs Medical Center - Boston (Jamaica Plain)

Jamaica Plain, Massachusetts, United States

Site Status

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

McLaren Regional Cancer Center

Flint, Michigan, United States

Site Status

Hurley Medical Center

Flint, Michigan, United States

Site Status

CCOP - Kalamazoo

Kalamazoo, Michigan, United States

Site Status

Marquette General Hospital

Marquette, Michigan, United States

Site Status

MidMichigan Medical Center - Midland

Midland, Michigan, United States

Site Status

William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

St. Mary's Medical Center

Saginaw, Michigan, United States

Site Status

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Site Status

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

Site Status

North Mississippi Medical Center/Cancer Center

Tupelo, Mississippi, United States

Site Status

Ellis Fischel Cancer Center - Columbia

Columbia, Missouri, United States

Site Status

CCOP - Kansas City

Kansas City, Missouri, United States

Site Status

Cancer Research for the Ozarks

Springfield, Missouri, United States

Site Status

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, United States

Site Status

St. Louis University Health Sciences Center

St Louis, Missouri, United States

Site Status

Mallinckrodt Institute of Radiology

St Louis, Missouri, United States

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CCOP - Montana Cancer Consortium

Billings, Montana, United States

Site Status

Nebraska Health System

Omaha, Nebraska, United States

Site Status

Methodist Cancer Center - Omaha

Omaha, Nebraska, United States

Site Status

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Site Status

Norris Cotton Cancer Center

Lebanon, New Hampshire, United States

Site Status

Elliot Regional Cancer Center

Manchester, New Hampshire, United States

Site Status

Cooper Cancer Institute

Camden, New Jersey, United States

Site Status

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, United States

Site Status

John F. Kennedy Medical Center

Edison, New Jersey, United States

Site Status

Trinitas Hospital - Jersey Street Campus

Elizabeth, New Jersey, United States

Site Status

Monmouth Medical Center

Long Branch, New Jersey, United States

Site Status

South Jersey Regional Cancer Center

Millville, New Jersey, United States

Site Status

Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County

Mount Holly, New Jersey, United States

Site Status

Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status

Atlantic City Medical Center

Pomona, New Jersey, United States

Site Status

Community Medical Center

Toms River, New Jersey, United States

Site Status

Capital Health System at Mercer

Trenton, New Jersey, United States

Site Status

St. Francis Medical Center

Trenton, New Jersey, United States

Site Status

Associated Radiologists, P.A.

Warren Township, New Jersey, United States

Site Status

Saint Joseph Medical Center

Albuquerque, New Mexico, United States

Site Status

Cancer Center of Albany Medical Center

Albany, New York, United States

Site Status

State University of New York Health Science Center at Brooklyn

Brooklyn, New York, United States

Site Status

New York Methodist Hospital

Brooklyn, New York, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Finger Lakes Radiation Oncology, P.C.

Clifton Springs, New York, United States

Site Status

CCOP - North Shore University Hospital

Manhasset, New York, United States

Site Status

Beth Israel Medical Center

New York, New York, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Site Status

Champlain Valley Physicians Hospital Medical Center

Plattsburgh, New York, United States

Site Status

Vassar Brothers Hospital

Poughkeepsie, New York, United States

Site Status

University of Rochester Cancer Center

Rochester, New York, United States

Site Status

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, United States

Site Status

New York Medical College

Valhalla, New York, United States

Site Status

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, United States

Site Status

Northeast Medical Center

Concord, North Carolina, United States

Site Status

East Carolina University School of Medicine

Greenville, North Carolina, United States

Site Status

Catawba Memorial Hospital

Hickory, North Carolina, United States

Site Status

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, United States

Site Status

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Meritcare Roger Maris Cancer Center

Fargo, North Dakota, United States

Site Status

Akron General Medical Center

Akron, Ohio, United States

Site Status

Akron City Hospital

Akron, Ohio, United States

Site Status

Christ Hospital

Cincinnati, Ohio, United States

Site Status

Ireland Cancer Center

Cleveland, Ohio, United States

Site Status

University Hospitals of Cleveland

Cleveland, Ohio, United States

Site Status

CCOP - Columbus

Columbus, Ohio, United States

Site Status

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, United States

Site Status

CCOP - Dayton

Kettering, Ohio, United States

Site Status

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, United States

Site Status

St. Anthony Hospital

Oklahoma City, Oklahoma, United States

Site Status

St. John Health System

Tulsa, Oklahoma, United States

Site Status

CCOP - Columbia River Program

Portland, Oregon, United States

Site Status

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Site Status

St. Luke's Hospital Regional Cancer Center

Bethlehem, Pennsylvania, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Mercy Catholic Medical Center, Mercy Fitzgerald Divison

Darby, Pennsylvania, United States

Site Status

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, United States

Site Status

Penn State Geisinger Cancer Center

Hershey, Pennsylvania, United States

Site Status

Hahnemann University Hospital

Philadelphia, Pennsylvania, United States

Site Status

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Veterans Affairs Medical Center - Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Site Status

Mercy Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Reading Hospital and Medical Center

Reading, Pennsylvania, United States

Site Status

Mercy Hospital Cancer Center - Scranton

Scranton, Pennsylvania, United States

Site Status

Wilkes Barre General Hospital

Wilkes-Barre, Pennsylvania, United States

Site Status

CCOP - MainLine Health

Wynnewood, Pennsylvania, United States

Site Status

York Hospital

York, Pennsylvania, United States

Site Status

Roger Williams Medical Center/BUSM

Providence, Rhode Island, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

CCOP - Greenville

Greenville, South Carolina, United States

Site Status

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

Site Status

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Site Status

Jackson-Madison County General Hospital

Jackson, Tennessee, United States

Site Status

University of Tennessee, Memphis Cancer Center

Memphis, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Harrington Cancer Center

Amarillo, Texas, United States

Site Status

Julie and Ben Rogers Cancer Institute

Beaumont, Texas, United States

Site Status

University of Texas Medical Branch

Galveston, Texas, United States

Site Status

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Wilford Hall - 59th Medical Wing

Lackland Air Force Base, Texas, United States

Site Status

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, United States

Site Status

Bayshore Medical Center

Pasadena, Texas, United States

Site Status

East Texas Medical Center - Cancer Institute

Tyler, Texas, United States

Site Status

University of Utah Health Sciences Center

Salt Lake City, Utah, United States

Site Status

LDS Hospital

Salt Lake City, Utah, United States

Site Status

Dixie Regional Medical Center

St. George, Utah, United States

Site Status

CCOP - Southwestern Vermont Regional Cancer Center

Bennington, Vermont, United States

Site Status

Vermont Cancer Center

Burlington, Vermont, United States

Site Status

Green Mountain Oncology Group

Rutland, Vermont, United States

Site Status

Martha Jefferson Hospital

Charlottesville, Virginia, United States

Site Status

Cancer Center at the University of Virginia

Charlottesville, Virginia, United States

Site Status

RMH Regional Canter Center

Harrisonburg, Virginia, United States

Site Status

Virginia Mason Medical Center

Seattle, Washington, United States

Site Status

Deaconess Medical Center

Spokane, Washington, United States

Site Status

Yakima Valley Memorial Hospital

Yakima, Washington, United States

Site Status

Schiffler Cancer Center

Wheeling, West Virginia, United States

Site Status

St. Vincent Hospital

Green Bay, Wisconsin, United States

Site Status

Gundersen Lutheran Medical Foundation

La Crosse, Wisconsin, United States

Site Status

Southern Wisconsin Radiotherapy Center

Madison, Wisconsin, United States

Site Status

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Site Status

Marshfield Clinic

Marshfield, Wisconsin, United States

Site Status

Community Memorial Hospital

Menomonee Falls, Wisconsin, United States

Site Status

St. Joseph's Hospital

Milwaukee, Wisconsin, United States

Site Status

Columbia Hospital

Milwaukee, Wisconsin, United States

Site Status

St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Veterans Affairs Medical Center - Milwaukee (Zablocki)

Milwaukee, Wisconsin, United States

Site Status

Southeastern Wisconsin Regional Cancer Center

Racine, Wisconsin, United States

Site Status

Waukesha Memorial Hospital

Waukesha, Wisconsin, United States

Site Status

Tom Baker Cancer Center - Calgary

Calgary, Alberta, Canada

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Site Status

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Site Status

Newfoundland Cancer Treatment and Research Foundation

St. John's, Newfoundland and Labrador, Canada

Site Status

Nova Scotia Cancer Centre

Halifax, Nova Scotia, Canada

Site Status

Northeastern Ontario Regional Cancer Centre, Sudbury

Greater Sudbury, Ontario, Canada

Site Status

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, Canada

Site Status

Kingston Regional Cancer Centre

Kingston, Ontario, Canada

Site Status

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, Canada

Site Status

Ottawa Regional Cancer Centre - General Campus

Ottawa, Ontario, Canada

Site Status

Northwestern Ontario Regional Cancer Centre, Thunder Bay

Thunder Bay, Ontario, Canada

Site Status

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, Canada

Site Status

Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

CHUS-Hopital Fleurimont

Fleurimont, Quebec, Canada

Site Status

McGill University

Montreal, Quebec, Canada

Site Status

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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United States Canada

References

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Bruner D, Scott C, McGowan D, et al.: Factors influencing sexual outcomes in prostate cancer patients enrolled on radiation therapy oncology group studies 90-20 and 94-08. [Abstract] Proceedings of the International Society for Quality of Life Research 7: 575, 1998.

Reference Type BACKGROUND

Bruner DW, Scott CB, McGowan D, et al.: Validation of the sexual adjustment questionnaire (SAQ) in prostate cancer patients enrolled on Radiation Therapy Oncology Group studies 90-20 and 94-08. [Abstract] Int J Radiat Oncol Biol Phys 42 (suppl 1): A-156, 202, 1998.

Reference Type BACKGROUND

Johnke RM, Edwards JM, Evans MJ, Nangami GN, Bakken NT, Kilburn JM, Lee TK, Allison RR, Karlsson UL, Arastu HH. Circulating cytokine levels in prostate cancer patients undergoing radiation therapy: influence of neoadjuvant total androgen suppression. In Vivo. 2009 Sep-Oct;23(5):827-33.

Reference Type BACKGROUND
PMID: 19779119 (View on PubMed)

Jones CU, Hunt D, McGowan DG, Amin MB, Chetner MP, Bruner DW, Leibenhaut MH, Husain SM, Rotman M, Souhami L, Sandler HM, Shipley WU. Radiotherapy and short-term androgen deprivation for localized prostate cancer. N Engl J Med. 2011 Jul 14;365(2):107-18. doi: 10.1056/NEJMoa1012348.

Reference Type RESULT
PMID: 21751904 (View on PubMed)

McGowan D, Hunt D, Jones C, et al.: Effect of short-term endocrine therapy prior to and during radiation therapy on overall survival in patients with T1b-T2b adenocarcinoma of the prostate and PSA equal to or less than 20: initial results of RTOG 94-08. [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-6, 2010.

Reference Type RESULT

Spratt DE, Tang S, Sun Y, Huang HC, Chen E, Mohamad O, Armstrong AJ, Tward JD, Nguyen PL, Lang JM, Zhang J, Mitani A, Simko JP, DeVries S, van der Wal D, Pinckaers H, Monson JM, Campbell HA, Wallace J, Ferguson MJ, Bahary JP, Schaeffer EM, Sandler HM, Tran PT, Rodgers JP, Esteva A, Yamashita R, Feng FY. Artificial Intelligence Predictive Model for Hormone Therapy Use in Prostate Cancer. NEJM Evid. 2023 Aug;2(8):EVIDoa2300023. doi: 10.1056/EVIDoa2300023. Epub 2023 Jun 29.

Reference Type DERIVED
PMID: 38320143 (View on PubMed)

Jones CU, Pugh SL, Sandler HM, Chetner MP, Amin MB, Bruner DW, Zietman AL, Den RB, Leibenhaut MH, Longo JM, Bahary JP, Rosenthal SA, Souhami L, Michalski JM, Hartford AC, Amin PP, Roach M 3rd, Yee D, Efstathiou JA, Rodgers JP, Feng FY, Shipley WU. Adding Short-Term Androgen Deprivation Therapy to Radiation Therapy in Men With Localized Prostate Cancer: Long-Term Update of the NRG/RTOG 9408 Randomized Clinical Trial. Int J Radiat Oncol Biol Phys. 2022 Feb 1;112(2):294-303. doi: 10.1016/j.ijrobp.2021.08.031. Epub 2021 Sep 1.

Reference Type DERIVED
PMID: 34481017 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CDR0000063821

Identifier Type: -

Identifier Source: secondary_id

RTOG-9408

Identifier Type: -

Identifier Source: org_study_id

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