Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT Vs AS and 3DCTR/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk, Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288080
• Other study ID #: RTOG-0521
• Secondary ID: CDR0000462375NCI
• Status: Completed
• Phase: Phase 3
• Start date: December 2005
• Est. completion date: May 20, 2022

Study information

• Verified date: May 2022
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy using drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may fight prostate cancer by lowering the amount of androgens the body makes. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving hormone therapy and radiation therapy together with chemotherapy is more effective than giving hormone therapy together with radiation therapy in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying hormone therapy and radiation therapy followed by docetaxel and prednisone to see how well it works compared to hormone therapy and radiation therapy in treating patients with localized prostate cancer.

Description:

OBJECTIVES:

Primary

• Compare the relative efficacy, in terms of overall survival, of the combination of androgen suppression and radiotherapy versus androgen suppression and radiotherapy followed by docetaxel and prednisone in patients with localized, high-risk prostate cancer.

Secondary

• Compare the disease-free survival and incidence of adverse events in patients treated with these regimens.

• Compare the biochemical control, local control, and freedom from distant metastases in patients treated with these regimens.

• Determine the validity of prostate-specific antigen (PSA)-defined endpoints as a surrogate for overall survival of patients treated with these regimens.

• Compare the time interval between biochemical failure and distant metastases with respect to testosterone level in patients treated with these regimens.

OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to risk group.

• Arm I: Patients receive androgen suppression therapy comprising luteinizing hormone-releasing hormone (LHRH) agonist (e.g., leuprolide acetate, goserelin, buserelin, or triptorelin) and oral antiandrogen (i.e., oral flutamide 3 times daily for 2 months or oral bicalutamide once daily for 2 months). Beginning at week 8, patients undergo radiotherapy 5 days a week for approximately 8 weeks. Antiandrogen therapy is discontinued at completion of radiotherapy, but LHRH agonist therapy continues for 20 months.

• Arm II: Patients receive androgen suppression therapy and undergo radiotherapy as in arm I. Beginning 4 weeks after completion of radiotherapy, patients receive docetaxel IV over 1 hour on day 1 and oral prednisone daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients continue LHRH agonist therapy as in arm I.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 612
• Est. completion date: May 20, 2022
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed prostate cancer at high-risk for recurrence within the past 180 days as determined by 1 of the following combinations (risk groups):

• Gleason score = 9, prostate-specific antigen (PSA) = 150 ng/mL, and any T stage

• Gleason score 8, PSA < 20 ng/mL, and stage = T2

• Gleason score 8, PSA 20-150 ng/mL, and any T stage

• Gleason score 7, PSA 20-150 ng/mL, and any T stage

• Clinically negative lymph nodes by imaging (pelvic CT scan or pelvic MRI), nodal sampling, or dissection within 90 days prior to study entry

• Equivocal or questionable lymph nodes = 1.5 cm by imaging allowed

• Positive lymph nodes by capromab pendetide (ProstaScint^®) scan with a corresponding lymph node = 1.5 cm by CT scan or MRI allowed

• PSA = 150 ng/mL

• Cannot have been obtained during any of the following time points:

• 10-day period after prostate biopsy

• After initiation of hormonal therapy

• Within 30 days after discontinuation of finasteride

• Within 90 days after discontinuation of dutasteride

• No distant metastases by physical exam and bone scan

• Equivocal bone scan findings allowed if plain films are negative

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1

• Platelet count = 100,000/mm^3

• Absolute neutrophil count = 1,800/mm^3

• Hemoglobin = 8 g/dL (transfusion or other intervention allowed)

• Alanine transaminase (ALT) and aspartate aminotransferase (AST) = 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase = 2.5 times ULN

• Bilirubin = 1.5 times ULN

• Fertile patients must use effective contraception during and for at least 3 months after completion of study treatment

• No prior invasive malignancy, except nonmelanomatous skin cancer or other malignancy, unless disease-free for = 3 years (e.g., carcinoma in situ of the oral cavity or bladder are allowed)

• No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months

• No transmural myocardial infarction within the past 6 months

• No acute bacterial or fungal infection requiring intravenous antibiotics

• No AIDS

• No prior allergic reaction to any study drugs or other drugs formulated with polysorbate 80

• No existing peripheral neuropathy = grade 2

PRIOR CONCURRENT THERAPY:

• At least 60 days since prior 5-alpha reductase inhibitor (e.g., finasteride) for prostatic hypertrophy

• At least 90 days since prior testosterone

• Prior pharmacologic androgen ablation for prostate cancer allowed provided androgen ablation was initiated no more than 50 days prior to study entry

• No prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy

• No prior systemic chemotherapy for prostate cancer

• Prior chemotherapy for a different cancer is allowed

• No prior radiotherapy, including brachytherapy, to the region of prostate cancer that would result in overlap of radiotherapy fields

• Intensity modulated radiotherapy allowed

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Dexamethasone
Premedication of dexamethasone prior to docetaxel, per institutional standards.
• Prednisone
10 mg orally per day until day 21 of the last cycle of docetaxel, beginning 28 days after the completion of RT.
• docetaxel
75 mg/m2 i.v. over 1 hour (on day 1 of each cycle) every 21 days for 6 cycles, beginning 28 days after the completion of RT.
• Oral antiandrogen
Oral antiandrogen of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy. Treatment is discontinued at the end of radiation therapy.

Radiation:
• Radiation therapy
46.8 Gy, using either three-dimensional conformal radiotherapy (3DCRT) or intensity-modulated radiation therapy (IMRT), will be given to the regional lymphatics followed by a 25.2-28.8 Gy boost to the prostate, to bring the total dose to the prostate to 72.0-75.6 Gy. Daily prescription doses will be 1.8 Gy per day, 5 days per week x 8-8.5 weeks, beginning 8 weeks after the initiation of androgen suppression.

Drug:
• LHRH agonist
LHRH agonist of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy, and then until 24 months from initiation of any treatment has been reached.

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre - Calgary	Calgary	Alberta
Canada	Cross Cancer Institute at University of Alberta	Edmonton	Alberta
Canada	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario
Canada	London Regional Cancer Program at London Health Sciences Centre	London	Ontario
Canada	Hopital Notre-Dame du CHUM	Montreal	Quebec
Canada	McGill Cancer Centre at McGill University	Montreal	Quebec
Canada	Ottawa Hospital Regional Cancer Centre - General Campus	Ottawa	Ontario
Canada	Centre Hospitalier Universitaire de Quebec	Quebec City	Quebec
Canada	Allan Blair Cancer Centre at Pasqua Hospital	Regina	Saskatchewan
United States	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania
United States	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan
United States	Summa Center for Cancer Care at Akron City Hospital	Akron	Ohio
United States	New York Oncology Hematology, PC at Albany Regional Cancer Care	Albany	New York
United States	Lovelace Medical Center - Downtown	Albuquerque	New Mexico
United States	New Mexico Cancer Center	Albuquerque	New Mexico
United States	Radiation Oncology Associates, PA	Albuquerque	New Mexico
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	Tulane Cancer Center Office of Clinical Research	Alexandria	Louisiana
United States	McFarland Clinic, PC	Ames	Iowa
United States	Providence Cancer Center	Anchorage	Alaska
United States	Saint John's Cancer Center at Saint John's Medical Center	Anderson	Indiana
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	DeCesaris Cancer Institute at Anne Arundel Medical Center	Annapolis	Maryland
United States	Theda Care Cancer Institute	Appleton	Wisconsin
United States	Northwest Community Hospital	Arlington Heights	Illinois
United States	Georgia Cancer Center for Excellence at Grady Memorial Hospital	Atlanta	Georgia
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	Auburn Radiation Oncology	Auburn	California
United States	Rocky Mountain Cancer Centers - Aurora	Aurora	Colorado
United States	University of Colorado Cancer Center at UC Health Sciences Center	Aurora	Colorado
United States	St. Agnes Hospital Cancer Center	Baltimore	Maryland
United States	Barberton Citizens Hospital	Barberton	Ohio
United States	UPMC Cancer Center at Beaver Medical Center	Beaver	Pennsylvania
United States	Texas Oncology, PA at Harris Center HEB	Bedford	Texas
United States	Suburban Hospital	Bethesda	Maryland
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	UAB Comprehensive Cancer Center	Birmingham	Alabama
United States	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center	Boise	Idaho
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	St. Vincent's Medical Center	Bridgeport	Connecticut
United States	St. Joseph Regional Cancer Center	Bryan	Texas
United States	Providence Saint Joseph Medical Center - Burbank	Burbank	California
United States	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Cancer Institute of New Jersey at Cooper University Hospital - Camden	Camden	New Jersey
United States	Radiation Oncology Centers - Cameron Park	Cameron Park	California
United States	Cancer Institute of Cape Girardeau, LLC	Cape Girardeau	Missouri
United States	Mercy Cancer Center at Mercy San Juan Medical Center	Carmichael	California
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina
United States	West Virginia University Health Sciences Center - Charleston	Charleston	West Virginia
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina
United States	Enloe Cancer Center at Enloe Medical Center	Chico	California
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	UPMC Cancer Center at Jefferson Regional Medical Center	Clairton	Pennsylvania
United States	Cancer Center at Clarion Hospital	Clarion	Pennsylvania
United States	Cleveland Clinic Cancer Center at Fairview Hospital	Cleveland	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	John B. Amos Cancer Center	Columbus	Georgia
United States	Cancer Care Center at John Muir Health - Concord Campus	Concord	California
United States	Dartmouth - Hitchcock Concord	Concord	New Hampshire
United States	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota
United States	Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital	Cooperstown	New York
United States	Medical City Dallas Hospital	Dallas	Texas
United States	Texas Oncology, PA at Texas Cancer Center Dallas Southwest	Dallas	Texas
United States	Mercy Fitzgerald Hospital	Darby	Pennsylvania
United States	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio
United States	Good Samaritan Hospital	Dayton	Ohio
United States	Grandview Hospital	Dayton	Ohio
United States	Samaritan North Cancer Care Center	Dayton	Ohio
United States	Veterans Affairs Medical Center - Dayton	Dayton	Ohio
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	Seacoast Cancer Center at Wentworth - Douglass Hospital	Dover	New Hampshire
United States	Delaware County Regional Cancer Center at Delaware County Memorial Hospital	Drexel Hill	Pennsylvania
United States	St. Luke's Hospital Cancer Care Center	Duluth	Minnesota
United States	Northeast Radiation Oncology Center	Dunmore	Pennsylvania
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Elmhurst Memorial Hospital	Elmhurst	Illinois
United States	Swedish Medical Center	Englewood	Colorado
United States	Willamette Valley Cancer Center - Eugene	Eugene	Oregon
United States	Center for Cancer Care at Exeter Hospital	Exeter	New Hampshire
United States	Hudner Oncology Center at Saint Anne's Hospital - Fall River	Fall River	Massachusetts
United States	Poudre Valley Radiation Oncology	Fort Collins	Colorado
United States	Parkview Regional Cancer Center at Parkview Health	Fort Wayne	Indiana
United States	Radiation Oncology Associates Southwest	Fort Wayne	Indiana
United States	Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital	Fort Worth	Texas
United States	Middletown Regional Hospital	Franklin	Ohio
United States	CentraState Medical Center	Freehold	New Jersey
United States	Washington Township Hospital	Fremont	California
United States	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	University of Florida Shands Cancer Center	Gainesville	Florida
United States	CaroMont Cancer Center at Gaston Memorial Hospital	Gastonia	North Carolina
United States	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	Colorado
United States	Sierra Nevada Cancer Center at Sierra Nevada Memorial Hospital	Grass Valley	California
United States	Great Falls Clinic - Main Facility	Great Falls	Montana
United States	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana
United States	North Colorado Medical Center	Greeley	Colorado
United States	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	UPMC Cancer Center - Arnold Palmer Pavilion	Greensburg	Pennsylvania
United States	CCOP - Greenville	Greenville	South Carolina
United States	Leo W. Jenkins Cancer Center at ECU Medical School	Greenville	North Carolina
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	High Point Regional Hospital	High Point	North Carolina
United States	Cancer Research Center of Hawaii	Honolulu	Hawaii
United States	M. D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Cleveland Clinic Cancer Center	Independence	Ohio
United States	Central Indiana Cancer Centers - East	Indianapolis	Indiana
United States	Veterans Affairs Medical Center - Indianapolis	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	UPMC Cancer Center at the John P. Murtha Pavilion	Johnstown	Pennsylvania
United States	St. John's Regional Medical Center	Joplin	Missouri
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Kansas City Cancer Centers - North	Kansas City	Missouri
United States	Kansas City Cancer Centers - South	Kansas City	Missouri
United States	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas
United States	Kingsbury Center for Cancer Care at Cheshire Medical Center	Keene	New Hampshire
United States	Charles F. Kettering Memorial Hospital	Kettering	Ohio
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	Gundersen Lutheran Center for Cancer and Blood	La Crosse	Wisconsin
United States	Rebecca and John Moores UCSD Cancer Center	La Jolla	California
United States	Breslin Cancer Center at Ingham Regional Medical Center	Lansing	Michigan
United States	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Nevada Cancer Institute	Las Vegas	Nevada
United States	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Lima Memorial Hospital	Lima	Ohio
United States	Norton Suburban Hospital	Louisville	Kentucky
United States	McKee Medical Center	Loveland	Colorado
United States	Elliot Regional Cancer Center at Elliot Hospital	Manchester	New Hampshire
United States	Shields Radiation Oncology Center - Mansfield	Mansfield	Massachusetts
United States	Minnesota Oncology Hematology, PA - Maplewood	Maplewood	Minnesota
United States	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin
United States	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Marlton	New Jersey
United States	Northwest Ohio Oncology Center	Maumee	Ohio
United States	Hillcrest Cancer Center at Hillcrest Hospital	Mayfield Heights	Ohio
United States	UPMC Cancer Center at UPMC McKeesport	McKeesport	Pennsylvania
United States	Community Memorial Hospital Cancer Care Center	Menomonee Falls	Wisconsin
United States	Columbia Saint Mary's Hospital - Ozaukee	Mequon	Wisconsin
United States	Columbia-Saint Mary's Cancer Care Center	Milwaukee	Wisconsin
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Veterans Affairs Medical Center - Milwaukee	Milwaukee	Wisconsin
United States	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital	Minneapolis	Minnesota
United States	Memorial Medical Center	Modesto	California
United States	UPMC - Moon	Moon	Pennsylvania
United States	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center	Murray	Utah
United States	UPMC Cancer Center - Natrona Heights	Natrona Heights	Pennsylvania
United States	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Saint Peter's University Hospital	New Brunswick	New Jersey
United States	Jameson Memorial Hospital - North Campus	New Castle	Pennsylvania
United States	Hospital of Saint Raphael	New Haven	Connecticut
United States	Yale Cancer Center	New Haven	Connecticut
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Eastern Connecticut Hematology and Oncology Associates	Norwich	Connecticut
United States	William W. Backus Hospital	Norwich	Connecticut
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center	Ogden	Utah
United States	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma
United States	Alegant Health Cancer Center at Bergan Mercy Medical Center	Omaha	Nebraska
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Immanuel Medical Center	Omaha	Nebraska
United States	Methodist Estabrook Cancer Center	Omaha	Nebraska
United States	St. Charles Mercy Hospital	Oregon	Ohio
United States	Kansas City Cancer Centers - Southwest	Overland Park	Kansas
United States	Bay Medical	Panama City	Florida
United States	Cancer Center of Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Advocate Lutheran General Cancer Care Center	Park Ridge	Illinois
United States	Regional Cancer Center at Singing River Hospital	Pascagoula	Mississippi
United States	NSMC Cancer Center - Peabody	Peabody	Massachusetts
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Arizona Oncology Services Foundation	Phoenix	Arizona
United States	UPMC - Shadyside	Pittsburgh	Pennsylvania
United States	UPMC Cancer Center - Upper St. Clair	Pittsburgh	Pennsylvania
United States	UPMC Cancer Center at Magee-Womens Hospital	Pittsburgh	Pennsylvania
United States	UPMC Cancer Center at UPMC Passavant	Pittsburgh	Pennsylvania
United States	UPMC Cancer Center at UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	UPMC Cancer Center at UPMC St. Margaret	Pittsburgh	Pennsylvania
United States	Knight Cancer Institute at Oregon Health and Science University	Portland	Oregon
United States	Naval Medical Center - Portsmouth	Portsmouth	Virginia
United States	South Suburban Oncology Center	Quincy	Massachusetts
United States	Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center	Rancho Mirage	California
United States	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center	Reading	Pennsylvania
United States	Veterans Affairs Medical Center - Richmond	Richmond	Virginia
United States	Virginia Commonwealth University Massey Cancer Center	Richmond	Virginia
United States	Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center	Robbinsdale	Minnesota
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Center for Cancer Care at OSF Saint Anthony Medical Center	Rockford	Illinois
United States	Radiation Oncology Center - Roseville	Roseville	California
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	Community Cancer Center at Rutland Regional Medical Center	Rutland	Vermont
United States	Mercy General Hospital	Sacramento	California
United States	Radiological Associates of Sacramento Medical Group, Incorporated	Sacramento	California
United States	University of California Davis Cancer Center	Sacramento	California
United States	Dixie Regional Medical Center - East Campus	Saint George	Utah
United States	David C. Pratt Cancer Center at St. John's Mercy	Saint Louis	Missouri
United States	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	United Hospital	Saint Paul	Minnesota
United States	Cancer Care Center, Incorporated	Salem	Ohio
United States	Salem Hospital Regional Cancer Care Services	Salem	Oregon
United States	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah
United States	California Pacific Medical Center - California Campus	San Francisco	California
United States	Cancer Institute of New Mexico	Santa Fe	New Mexico
United States	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia
United States	Guthrie Cancer Center at Guthrie Clinic Sayre	Sayre	Pennsylvania
United States	Maine Center for Cancer Medicine and Blood Disorders - Scarborough	Scarborough	Maine
United States	Grand View Hospital	Sellersville	Pennsylvania
United States	UPMC Cancer Center at UPMC Northwest	Seneca	Pennsylvania
United States	Vince Lombardi Cancer Clinic - Sheboygan	Sheboygan	Wisconsin
United States	Texas Oncology, PA at Texas Cancer Center - Sherman	Sherman	Texas
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Providence Cancer Center at Sacred Heart Medical Center	Spokane	Washington
United States	Cancer Institute at St. John's Hospital	Springfield	Illinois
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land	Sugar Land	Texas
United States	Flower Hospital Cancer Center	Sylvania	Ohio
United States	SUNY Upstate Medical University Hospital	Syracuse	New York
United States	Veterans Affairs Medical Center - Syracuse	Syracuse	New York
United States	CCOP - Northwest	Tacoma	Washington
United States	Madigan Army Medical Center - Tacoma	Tacoma	Washington
United States	Celilo Cancer Center at Mid-Columbia Medical Center	The Dalles	Oregon
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	Medical University of Ohio Cancer Center	Toledo	Ohio
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Torrance Memorial Medical Center	Torrance	California
United States	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio
United States	Arizona Oncology - Tucson	Tucson	Arizona
United States	Natalie Warren Bryant Cancer Center at St. Francis Hospital	Tulsa	Oklahoma
United States	UPMC Cancer Center - Uniontown	Uniontown	Pennsylvania
United States	Solano Radiation Oncology Center	Vacaville	California
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	John Muir/Mt. Diablo Comprehensive Cancer Center	Walnut Creek	California
United States	Washington Hospital Cancer Center	Washington	Pennsylvania
United States	University of Wisconcin Cancer Center at Aspirus Wausau Hospital	Wausau	Wisconsin
United States	Exempla Lutheran Medical Center	Wheat Ridge	Colorado
United States	New Hanover Radiation Oncology, PA	Wilmington	North Carolina
United States	Forsyth Regional Cancer Center at Forsyth Medical Center	Winston-Salem	North Carolina
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina
United States	Cancer Treatment Center	Wooster	Ohio
United States	Cleveland Clinic - Wooster	Wooster	Ohio
United States	CCOP - Main Line Health	Wynnewood	Pennsylvania
United States	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania
United States	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio
United States	York Cancer Center at Apple Hill Medical Center	York	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI), NRG Oncology

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Patel AR, Sandler HM, Pienta KJ. Radiation Therapy Oncology Group 0521: a phase III randomized trial of androgen suppression and radiation therapy versus androgen suppression and radiation therapy followed by chemotherapy with docetaxel/prednisone for loc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Four-year rates are shown. Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.	From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.
Secondary	Biochemical Control	Four-year rates are shown (Kaplan-Meier estimates). Biochemical control is defined as freedom from biochemical failure. Biochemical failure was considered as the first of either prostate-specific antigen (PSA) failure or initiation of salvage hormone therapy. PSA failure was defined as a rise of 2 ng/ml over the nadir PSA. Patients who experienced death without biochemical failure, local failure prior to biochemical failure, or development of distant metastases prior to biochemical failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization.	From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.
Secondary	Local Control	Local control is defined as the absence of local failure which is the first of either progression or recurrence within the prostate. Progression of the tumor was considered to have occurred when there was a 25% or greater increase in the product of the two largest perpendicular diameters of the prostate. Recurrence was defined as the reappearance of disease after a complete response. Patients who experienced death without local failure, biochemical failure prior to local failure, and development of distant metastases prior to local failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Due to an insufficient number of events (2 in each arm), this endpoint was not statistically compared. Local control rates at 4 years were calculated using the Kaplan-Meier method.	From randomization to date of local failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.
Secondary	Distant Metastasis	Distant failure was considered when there was evidence of metastatic disease. Patients who experienced death without distant failure, local failure prior to distant failure, and biochemical failure prior to distant failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Distant failure rates at 4 year were calculated using the Kaplan-Meier method.	From randomization to date of distant metastasis, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.
Secondary	Disease-free Survival	A failure for disease-free survival is the first of the following: biochemical failure, local failure, distant metastases, or death due to any cause. The corresponding outcome time was measured from the date of randomization. Disease-free survival rates at 4 years were calculated using the Kaplan-Meier method.	From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.
Secondary	Incidence of Adverse Events	Adverse events are graded using CTCAE v3.0. The worst grade of all adverse events for each patient is counted.	From start of treatment until the end of follow-up
Secondary	The Time Interval Between Biochemical Failure and Distant Failure Respect to Testosterone Level	Biochemical failure is defined as the first of either prostate-specific antigen (PSA) failure or the initiation of salvage hormone therapy. PSA failure is defined as a rise in PSA of 2 ng/ml over the nadir PSA. Distant failure is defined as the first occurrence of distant metastasis.	From date of biochemical failure to development of distant metastasis. Maximum follow-up was 12.9 years.
Secondary	Validity of PSA Endpoint as a Surrogate for Overall Survival	Prentice's operational criteria for determining whether determining whether biochemical failure (surrogate endpoint) is a suitable endpoint for overall survival (true endpoint): Treatment is prognostic for true endpoint; Treatment is prognostic for surrogate endpoint; Surrogate is prognostic for true endpoint; The full effect of the treatment on the true endpoint is explained by the surrogate.; If any of the criteria are not met, it is concluded that biochemical failure is not a suitable surrogate for overall survival. Therefore, if any of the criteria are met, the other criteria do not do not need to be evaluated.	From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.