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Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

bicalutamide

flutamide

LHRH agonist (antagonist) therapy

Dose-Escalated Radiation Therapy

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma, at intermediate risk for recurrence, within 180 days prior to registration as determined by having one or more of the following intermediate-risk features: Gleason score 7; prostate-specific antigen (PSA) >10 but ≤20; clinical stage T2b-T2c.
- Patients previously diagnosed with low risk (Gleason score ≤ 6, clinical stage < T2a, and PSA < 10) prostate cancer undergoing active surveillance who are re-biopsied and found to have intermediate risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure.
Clinically negative lymph nodes as established by imaging (pelvic +/- abdominal CT or MRI), nodal sampling, or dissection within 60 days prior to registration, except as noted immediately below:
- Patients with a single intermediate risk factor only do not require abdominopelvic imaging, but these studies may be obtained at the discretion of the treating physician. Patients with 2 or 3 risk factors are required to undergo pelvic +/- abdominal CT or MRI.
- Patients with lymph nodes equivocal or questionable by imaging are eligible without biopsy if the nodes are ≤1.5 cm; any node larger than this on imaging will require negative biopsy for eligibility.
No evidence of bone metastases (M0) on bone scan within 60 days prior to registration.
- Bone scan is not required for patients enrolled with a single intermediate risk factor only, but this scan may be obtained at the discretion of the treating physician. Patients with 2 or 3 risk factors will require a negative bone scan for eligibility.
- Equivocal bone scan findings are allowed if plain film x-rays are negative for metastasis.
History/physical examination (to include, at a minimum, digital rectal examination of the prostate and examination of the skeletal system and abdomen, and formal comorbidity assessment via the ACE-27 instrument) within 60 days prior to registration.
Zubrod Performance Status 0-1
Age ≥ 18
Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 60 days prior to registration
- Study entry PSA must not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of ADT; (3) within 30 days after discontinuation of finasteride; or (4) within 90 days after discontinuation of dutasteride.
For patients undergoing brachytherapy only: complete blood count (CBC)/differential obtained within 60 days prior to registration, with adequate bone marrow function defined as follows:
- Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3
- Platelets ≥ 100,000 cells/mm3
- Hemoglobin (Hgb) ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
Patient must be able to provide study-specific informed consent prior to study entry.

Exclusion Criteria:

Patients with Gleason Score ≥ 8; PSA > 20; OR Clinical Stage ≥ T3 are ineligible for this trial.
- Should findings of extracapsular extension or seminal vesicle invasion be noted on prostate MRI, this study, if used, will not render patients ineligible for accrual to this protocol. Primary tumor staging for eligibility purposes is to be based on palpable or core biopsy evidence only with respect to extracapsular extension or seminal vesicle involvement.
Patients with all three intermediate risk factors who also have ≥ 50% of the number of their biopsy cores positive for cancer are ineligible for this trial.
Prior invasive malignancy (except non-melanomatous skin cancer) or hematological (e.g., leukemia, lymphoma, myeloma) malignancy unless disease free for a minimum of 5 years (prior diagnoses of carcinoma in situ are permitted)
Prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery for prostate cancer
Prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy
Use of finasteride within 30 days prior to registration
Use of dutasteride within 90 days prior to registration
Prior or concurrent cytotoxic chemotherapy for prostate cancer; prior chemotherapy for a different cancer is permitted.
Prior RT, including brachytherapy, to the region of the study cancer that would result in overlap of RT fields
- Any patient undergoing brachytherapy must have transrectal ultrasound confirmation of prostate volume <60 cc, American Urological Association Symptom Index (AUA-SI) score ≤15 within 60 days of registration, and no history of prior transurethral resection of the prostate (TURP); prior TURP is permitted for patients who receive EBRT only)
Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
- Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. While the treatment employed in this study is not significantly immunosuppressive, it is felt that a diagnosis of AIDS associated with prostate cancer is likely to impact this study's primary endpoint of overall survival. Patients who are HIV seropositive but do not meet criteria for diagnosis of AIDS are eligible for study participation.
Men who are sexually active with a woman of child-bearing potential and not willing/able to use medically acceptable forms of contraception (e.g., surgical, barrier, medicinal) during protocol treatment and during the first 3 months after cessation of protocol treatment; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.

Sites / Locations

University of Alabama at Birmingham Cancer Center
Fairbanks Memorial Hospital
Arizona Center for Cancer Care-Peoria
Saint Joseph's Hospital and Medical Center
21st Century Oncology-Scottsdale
Mayo Clinic in Arizona
Arizona Oncology Services Foundation
Arizona Oncology Associates-West Orange Grove
Mercy Cancer Center-Hot Springs
Sutter Cancer Centers Radiation Oncology Services-Auburn
Alta Bates Summit Medical Center-Herrick Campus
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Mercy San Juan Medical Center
Enloe Medical Center
21st Century Oncology - El Segundo
Fresno Cancer Center
Saint Agnes Medical Center
Marin General Hospital
Veterans Administration Long Beach Medical Center
Los Angeles County-USC Medical Center
USC / Norris Comprehensive Cancer Center
Memorial Medical Center
Kaiser Permanente Oakland-Broadway
Kaiser Permanente-Oakland
Desert Regional Medical Center
Stanford Cancer Institute
Feather River Cancer Center
Pomona Valley Hospital Medical Center
Kaiser Permanente-Rancho Cordova Cancer Center
Kaiser Permanente-Redwood City
Kaiser Permanente-Richmond
Rohnert Park Cancer Center
Kaiser Permanente-Roseville
Sutter Cancer Centers Radiation Oncology Services-Roseville
The Permanente Medical Group-Roseville Radiation Oncology
Sutter General Hospital
University of California Davis Comprehensive Cancer Center
Mercy General Hospital Radiation Oncology Center
Kaiser Permanente-South Sacramento
South Sacramento Cancer Center
Kaiser Permanente - Sacramento
University of California San Diego
Kaiser Permanente-San Francisco
UCSF Medical Center-Mount Zion
California Pacific Medical Center-Pacific Campus
Kaiser Permanente-Santa Teresa-San Jose
Kaiser Permanente San Leandro
Kaiser Permanente-San Rafael
Kaiser Permanente Medical Center - Santa Clara
Kaiser Permanente-Santa Rosa
Kaiser Permanente Cancer Treatment Center
Kaiser Permanente-South San Francisco
Kaiser Permanente-Stockton
David Grant United States Air Force Medical Center
Tahoe Forest Cancer Center
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Sutter Solano Medical Center/Cancer Center
Kaiser Permanente-Walnut Creek
Rocky Mountain Cancer Centers-Aurora
University of Colorado Cancer Center - Anschutz Cancer Pavilion
The Urology Center of Colorado
The Shaw Regional Cancer Center
Poudre Valley Hospital
Saint Mary's Hospital and Regional Medical Center
Rocky Mountain Cancer Centers-Littleton
Hartford Hospital
Saint Francis Hospital and Medical Center
Midstate Medical Center
The Hospital of Central Connecticut
Yale-New Haven Hospital Saint Raphael Campus
Helen F Graham Cancer Center
Christiana Care Health System-Christiana Hospital
University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach
Broward Health Medical Center
Mayo Clinic in Florida
Florida Hospital Kissimmee
Lakeland Regional Cancer Center
The Watson Clinic
Jackson Memorial Hospital-Holtz Children's Hospital
University of Miami Miller School of Medicine-Sylvester Cancer Center
South Miami Hospital
Florida Hospital Orlando
Bay Medical Center
James A. Haley Veterans Affairs Hospital
Grady Health System
Piedmont Hospital
Emory University/Winship Cancer Institute
Northside Hospital
John B Amos Cancer Center
Northside Hospital-Forsyth
Atlanta VA Medical Center
Piedmont Fayette Hospital
Northeast Georgia Medical Center
Memorial University Medical Center
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Queen's Medical Center
University of Hawaii Cancer Center
The Cancer Center of Hawaii-Liliha
Saint Alphonsus Cancer Care Center-Boise
Idaho Urologic Institute-Meridian
Kootenai Cancer Center
Saint Anthony's Health
Memorial Hospital of Carbondale
Northwestern University
John H Stroger Jr Hospital of Cook County
University of Chicago Comprehensive Cancer Center
Advocate Illinois Masonic Medical Center
Decatur Memorial Hospital
Crossroads Cancer Center
Hines Veterans Administration Hospital
Loyola University Medical Center
Pekin Cancer Treatment Center
OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC
OSF Saint Francis Medical Center
SwedishAmerican Regional Cancer Center/ACT
Saint John's Hospital
Memorial Medical Center
Memorial and Saint Elizabeth's Health Care Services LLP
Saint Vincent Anderson Regional Hospital/Cancer Center
IU Health West Hospital
IU Health Bloomington
Radiation Oncology Associates PC
Parkview Hospital Randallia
IU Health Goshen Center for Cancer Care
Indiana University/Melvin and Bren Simon Cancer Center
IU Health Methodist Hospital
Richard L. Roudebush Veterans Affairs Medical Center
IU Health Central Indiana Cancer Centers-East
McFarland Clinic PC-William R Bliss Cancer Center
Medical Oncology and Hematology Associates-West Des Moines
Iowa Methodist Medical Center
Iowa Oncology Research Association CCOP
Medical Oncology and Hematology Associates-Des Moines
Medical Oncology and Hematology Associates-Laurel
Mercy Medical Center - Des Moines
Iowa Lutheran Hospital
Finley Hospital
Cancer Center of Kansas - Dodge City
Cancer Center of Kansas - El Dorado
Lawrence Memorial Hospital
Kansas City Cancer Centers-Southwest
Cancer Center of Kansas - Wellington
Associates In Womens Health
Cancer Center of Kansas-Wichita Medical Arts Tower
Cancer Center of Kansas - Main Office
Via Christi Regional Medical Center
Wesley Medical Center
Wichita CCOP
Cancer Center of Kansas - Winfield
Baptist Health Lexington
University of Kentucky/Markey Cancer Center
The James Graham Brown Cancer Center at University of Louisville
Owensboro Health Mitchell Memorial Cancer Center
Mary Bird Perkins Cancer Center
Tulane University Health Sciences Center
Ochsner Medical Center Jefferson
Central Maine Medical Center
Maine Medical Center- Scarborough Campus
Anne Arundel Medical Center
University of Maryland/Greenebaum Cancer Center
Greater Baltimore Medical Center
Saint Agnes Hospital
Upper Chesapeake Medical Center
Walter Reed National Military Medical Center
Central Maryland Radiation Oncology in Howard County
Tate Cancer Center
Holy Cross Hospital
Massachusetts General Hospital Cancer Center
Boston Medical Center
Mass General/North Shore Cancer Center
Saint Anne's Hospital
Cape Cod Hospital
Lowell General Hospital
Berkshire Hematology Oncology PC
Beth Israel Deaconess Hospital-Plymouth
D'Amour Center for Cancer Care
Baystate Medical Center
Saint Vincent Hospital/Reliant Medical Group
Bixby Medical Center
Veteran's Administration Medical Center - Ann Arbor
Saint Joseph Mercy Hospital
University of Michigan Comprehensive Cancer Center
Bronson Battle Creek
McLaren-Bay Region
Henry Ford Macomb Hospital
Huron Valley-Sinai Hospital
Henry Ford Hospital
Saint John Hospital and Medical Center
Green Bay Oncology - Escanaba
21st Century Oncology-Farmington Hills
Botsford General Hospital
Genesys Hurley Cancer Institute
Genesys Regional Medical Center-West Flint Campus
McLaren-Flint
Mercy Health Saint Mary's
Spectrum Health at Butterworth Campus
Green Bay Oncology - Iron Mountain
Borgess Medical Center
Bronson Methodist Hospital
West Michigan Cancer Center
Sparrow Hospital
Great Lakes Cancer Institute-Lapeer Campus
McLaren-Macomb
McLaren-Central Michigan
Mercy Health Mercy Campus
McLaren Cancer Institute-Owosso
Northern Michigan Regional Hospital
Saint Joseph Mercy Oakland
Saint Joseph Mercy Port Huron
Crittenton Hospital
William Beaumont Hospital-Royal Oak
Saint Mary's of Michigan
Downriver Center for Oncology
21st Century Oncology-Troy
William Beaumont Hospital - Troy
Saint John Macomb-Oakland Hospital
Henry Ford West Bloomfield Hospital
Mayo Clinic Health System in Albert Lea
Sanford Clinic North-Bemidgi
Miller-Dwan Hospital
Saint Luke's Hospital of Duluth
Fairview-Southdale Hospital
Mayo Clinic Health Systems-Mankato
Mayo Clinic
Regions Hospital
Saint Francis Medical Center
Mercy Hospital-Joplin
Kansas City Cancer Center - South
Kansas City Cancer Centers - North
Kansas City Cancer Center-Lee's Summit
Phelps County Regional Medical Center
Washington University School of Medicine
Siteman Cancer Center-South County
Missouri Baptist Medical Center
Barnes-Jewish West County Hospital
Mercy Hospital Saint Louis
Saint Louis-Cape Girardeau CCOP
Siteman Cancer Center - Saint Peters
Cancer Research for the Ozarks NCORP
Mercy Hospital Springfield
CoxHealth South Hospital
Montana Cancer Consortium CCOP
Northern Rockies Radiation Oncology Center
Billings Clinic Cancer Center
Berdeaux, Donald MD (UIA Investigator)
Great Falls Clinic
Saint Elizabeth Regional Medical Center
Missouri Valley Cancer Consortium
Nebraska Methodist Hospital
Alegent Health Immanuel Medical Center
Alegent Health Bergan Mercy Medical Center
Alegent Health Lakeside Hospital
Creighton University Medical Center
University of Nebraska Medical Center
Concord Hospital
Exeter Hospital
Cheshire Medical Center-Dartmouth-Hitchcock Keene
Dartmouth Hitchcock Medical Center
Elliot Hospital
Ocean Medical Center
Cooper Hospital University Medical Center
Veterans Adminstration New Jersey Health Care System
CentraState Medical Center
Princeton Radiation Oncology Center
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Jersey Shore Medical Center
Rutgers Cancer Institute of New Jersey
UMDNJ - Robert Wood Johnson University Hospital
UMDNJ - New Jersey Medical School
Newark Beth Israel Medical Center
The Medical Center At Princeton
Riverview Medical Center/Booker Cancer Center
Sparta Cancer Treatment Center
Community Medical Center
MD Anderson Cancer Center at Cooper-Voorhees
Virtua West Jersey Hospital Voorhees
Prostate Cancer Center of New Jersey
Lovelace Medical Center-Downtown
University of New Mexico
University of New Mexico Cancer Center
Radiation Oncology Associates
Memorial Medical Center - Las Cruces
New York Oncology Hematology PC - Albany
Saint Peters Hospital-Albany
Southside Hospital
Lourdes Hospital
State University of New York Downstate Medical Center
Veteran Affairs New York Harbor Healthcare System-Brooklyn Campus
Roswell Park Cancer Institute
Sands Cancer Center
Mary Imogene Bassett Hospital
Arnot Ogden Medical Center/Falck Cancer Center
North Shore University Hospital
North Shore-LIJ Health System NCORP
Long Island Jewish Medical Center
North Shore-LIJ Health System/Center for Advanced Medicine
Columbia University Medical Center
Hudson Valley Oncology Associates
Highland Hospital
University Radiation Oncology
University of Rochester
Randolph Hospital
University of North Carolina at Chapel Hill
Duke University Medical Center
Cone Health Cancer Center
The Coleman Radiation Center-Carteret General Hospital
CarolinaEast Health System-Medical Center
Duke Cancer Institute Macon Pond
Rex Cancer Center
South Atlantic Radiation Oncology
Coastal Carolina Radiation Oncology
New Hanover Regional Medical Center/Zimmer Cancer Center
Southeast Cancer Consortium-Upstate NCORP
Mid Dakota Clinic
Saint Alexius Medical Center
Sanford Bismarck Medical Center
Sanford Clinic North-Fargo
Sanford Medical Center-Fargo
Trinity Cancer Care Center
Summa Akron City Hospital/Cooper Cancer Center
Akron General Medical Center
Summa Barberton Hospital
UHHS-Chagrin Highlands Medical Center
Geaugra Hospital
Adena Regional Medical Center
University of Cincinnati
Case Western Reserve University
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland Clinic Foundation
Ohio State University Comprehensive Cancer Center
Riverside Methodist Hospital
Columbus CCOP
Grant Medical Center
The Mark H Zangmeister Center
Mount Carmel Health Center West
Doctors Hospital
Grady Memorial Hospital
Mercy Cancer Center-Elyria
Cleveland Clinic Cancer Center Independence
Marietta Memorial Hospital
Toledo Clinic Cancer Centers-Maumee
Hillcrest Hospital Cancer Center
Summa Health Center at Lake Medina
Lake University Ireland Cancer Center
Southwest General Health Center Ireland Cancer Center
Licking Memorial Hospital
Saint Charles Hospital
University Hospitals Parma Medical Center
Southern Ohio Medical Center
Robinson Radiation Oncology
Cancer Care Center, Incorporated
Ireland Cancer Center at Firelands Regional Medical Center
North Coast Cancer Care
Flower Hospital
University of Toledo
Mercy Saint Anne Hospital
University Pointe
Saint Ann's Hospital
UHHS-Westlake Medical Center
Cancer Treatment Center
Cleveland Clinic Wooster Specialty Center
Wright-Patterson Medical Center
Genesis HealthCare System
University of Oklahoma Health Sciences Center
Clackamas Radiation Oncology Center
Willamette Valley Cancer Center
Three Rivers Community Hospital
Legacy Mount Hood Medical Center
Asante Health System
Providence Medford Medical Center
Rogue Valley Medical Center
Providence Milwaukie Hospital
Legacy Good Samaritan Hospital and Medical Center
Providence Portland Medical Center
Western Oncology Research Consortium
Providence Saint Vincent Medical Center
Legacy Meridian Park Hospital
Abington Memorial Hospital
Saint Luke's University Hospital-Bethlehem Campus
Bryn Mawr Hospital
Geisinger Medical Center
Mercy Fitzgerald Hospital
Delaware County Memorial Hospital
Northeast Radiation Oncology Center
The Regional Cancer Center
Fox Chase Cancer Center Buckingham
Adams Cancer Center
Cherry Tree Cancer Center
Penn State Milton S Hershey Medical Center
Academic Urology Prostate Center
Saint Mary Medical and Regional Cancer Center
Upper Delaware Valley Cancer Center
Paoli Memorial Hospital
Thomas Jefferson University Hospital
Fox Chase Cancer Center
Temple University Hospital
Albert Einstein Medical Center
VA Pittsburgh Healthcare System
Reading Hospital
Lankenau Medical Center
Mainline Health CCOP
WellSpan Health-York Hospital
AnMed Health Hospital
Medical University of South Carolina
Greenville Health System Cancer Institute-Faris
Greenville Health System Cancer Institute-Eastside
Self Regional Healthcare
Greenville Health System Cancer Institute-Greer
Gibbs Cancer Center-Pelham
Carolina Regional Cancer Center
Greenville Health System Cancer Institute-Seneca
Spartanburg Medical Center
Greenville Health System Cancer Institute-Spartanburg
Rapid City Regional Hospital
Wellmont Holston Valley Hospital and Medical Center
Thompson Cancer Survival Center
Blount Memorial Hospital
Texas Oncology-Arlington South
Texas Oncology-Austin Midtown
Texas Oncology - Central Austin Cancer Center
Texas Oncology - South Austin Cancer Center
Texas Oncology Bedford
Texas Cancer Center - Medical City Dallas
Texas Oncology Methodist Charlton Cancer Center
UT Southwestern/Simmons Cancer Center-Dallas
Texas Oncology-Denton South
Brooke Army Medical Center
The Klabzuba Cancer Center
University of Texas Medical Branch
Memorial Hermann Memorial City Medical Center
M D Anderson Cancer Center
UTMB Cancer Center at Victory Lakes
Texas Oncology - Lewisville
Texas Oncology-Longview Cancer Center
West Texas Cancer Center
Texas Oncology-Seton Williamson
Texas Oncology - Round Rock Cancer Center
Texas Cancer Center-Sherman
Texas Oncology Cancer Center Sugar Land
Texas Oncology-Wichita Falls Texoma Cancer Center
Sandra L Maxwell Cancer Center
Intermountain Medical Center
McKay-Dee Hospital Center
Utah Valley Regional Medical Center
Dixie Medical Center Regional Cancer Center
Utah Cancer Specialists-Salt Lake City
Huntsman Cancer Institute/University of Utah
LDS Hospital
Southwestern Vermont Medical Center
Rutland Regional Medical Center
Norris Cotton Cancer Center-North
Inova Alexandria Hospital
Danville Regional Medical Center
Augusta Health Cancer Center
Sentara Cancer Institute at Sentara CarePlex Hospital
Sentara Rockingham Memorial Hospital Hahn Cancer Center
Sentara Hospitals
Southwest VA Regional Cancer Center
Naval Medical Center - Portsmouth
Oncology and Hematology Associates of Southwest Virginia
Sentara Virginia Beach General Hospital
PeaceHealth Saint Joseph Medical Center
Saint Francis Hospital
Virginia Mason CCOP
Virginia Mason Medical Center
Cancer Care Northwest - Spokane South
Cancer Care Northwest-North Spokane
PeaceHealth Southwest Medical Center
Compass Oncology Vancouver
Legacy Salmon Creek Hospital
Appleton Medical Center
Green Bay Oncology at Saint Vincent Hospital
Bellin Memorial Hospital
Saint Vincent Hospital
Green Bay Oncology Limited at Saint Mary's Hospital
Saint Mary's Hospital
Aurora BayCare Medical Center
UW Cancer Center Johnson Creek
Gundersen Lutheran Medical Center
Mayo Clinic Health System-Franciscan Healthcare
Bay Area Medical Center
Vince Lombardi Cancer Clinic-Marinette
Community Memorial Hospital
Columbia Saint Mary's Hospital - Ozaukee
Columbia Saint Mary's Water Tower Medical Commons
Aurora Saint Luke's Medical Center
Froedtert and the Medical College of Wisconsin
Zablocki Veterans Administration Medical Center
Green Bay Oncology - Oconto Falls
Vince Lombardi Cancer Clinic - Oshkosh
Wheaton Franciscan Cancer Care - All Saints
Door County Cancer Center
Green Bay Oncology - Sturgeon Bay
Aurora Medical Center in Summit
Aurora West Allis Medical Center
The Alyce and Elmore Kraemer Cancer Care Center
Riverview Hospital
Welch Cancer Center
Tom Baker Cancer Centre
Cross Cancer Institute
BCCA-Cancer Centre for the Southern Interior
BCCA-Vancouver Island Cancer Centre
Atlantic Health Sciences Corporation-Saint John Regional Hospital
QEII Health Sciences Centre/Capital District Health Authority
Juravinski Cancer Centre at Hamilton Health Sciences
London Regional Cancer Program
Ottawa Health Research Institute-General Division
Irving Greenberg Family Cancer Centre
Thunder Bay Regional Health Science Centre
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Hopital Maisonneuve-Rosemont
CHUM - Hopital Notre-Dame
McGill University Department of Oncology
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Allan Blair Cancer Centre
Saskatoon Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Dose-Escalated Radiation Therapy Alone

Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation

Arm Description

Radiation therapy consists of 79.2 Gy EBRT only or 45 Gy EBRT followed by low- or high-dose rate brachytherapy. EBRT is delivered in 1.8 Gy daily fractions.

Radiation therapy consists of 79.2 Gy EBRT only or 45 Gy EBRT followed by low- or high-dose rate brachytherapy. EBRT is delivered in 1.8 Gy daily fractions. Six months of androgen-deprivation therapy starts 8 weeks prior to start of radiation therapy and consists of luteinizing-hormone releasing-hormone (LHRH) agonist (antagonist) therapy (leuprolide, goserelin, buserelin. triptorelin, or degarelix) and anti-androgen therapy (bicalutamide or flutamide).

Outcomes

Primary Outcome Measures

Percentage of Participants Alive (Overall Survival)

Overall survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.

Secondary Outcome Measures

Percentage of Participants With Biochemical Failure

Biochemical failure is defined as an increase of at least 2 ng/ml above the nadir PSA. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.

Percentage of Participants With Local Recurrence

Local recurrence (failure) is defined as clinical (palpable) suspicion of local recurrence [this date is used] confirmed by biopsy. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.

Percentage of Participants With Regional Recurrence

Regional recurrence is defined as the documented progression in pelvic lymph nodes. If discovered on image of the pelvis prompted by a biochemical failure, then the event date would be the date of documented biochemical failure.

Percentage of Participants With Distant Metastasis

Distant metastasis (failure) is defined as metastatic disease documented by any method. If diagnosed on diagnostic imaging prompted by biochemical failure, then the event date will be the date of biochemical progression. Failure time is defined as time from randomization to the date of first failure, last known follow-up (competing risk), or death without failure (censored). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.

Percentage of Participants Dead Due to Prostate Cancer (Prostate Cancer-specific Mortality)

Prostate cancer specific mortality (failure) is defined as death due to prostate cancer or a complication from treatment. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.

Percentage of Participants Dead Due to Cause Other Than Prostate Cancer (Non-Prostate Cancer-specific Mortality)

Non-prostate cancer specific mortality is defined as a death without evidence of prostate cancer or a complication from treatment. . Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.

Percentage of Participants Receiving Salvage Androgen Deprivation Therapy (ADT)

Salvage (non-protocol) ADT administration is defined as the first administration of subsequent ADT (either LHRH agonist or anti-androgen) Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Salvage ADT rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of salvage ADT times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.

Percentage of Participants Alive (Overall Survival) by Radiation Therapy Modality

Number of Participants With Acute Adverse Events

Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Acute adverse events are defined as occuring within 30 days of completion of radiation therapy.

Percentage of Participants With Late Grade 3+ Adverse Events

Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Late adverse events are defined as occurring more than 30 days after the end of radiation therapy. Failure is defined as grade 3 or higher late adverse event. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.

Percentage of Participants Failed (Freedom From Failure)

Failure is defined as biochemical failure, local failure, or distant metastasis. Failure time is defined as time from randomization to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Five-year rates are provided here. Analysis was planned to occur after 218 deaths were reported.

Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Urinary Domain Score

The EPIC assesses disease-specific aspects of prostate cancer and it's therapies and consists of four summary domains (bowel, urinary, sexual, and hormonal), each ranging from 0-100, with higher scores representing better health-related quality of life. Change is calculated as time point value - baseline value, such that a positive change indicates improvement.

Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score

Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Hormonal Domain Score

Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Score

Change From Baseline in Patient Reported Outcome Measurement Information System (PROMIS) Fatigue Domain Score

The PROMIS Fatigue short form 8a contains 8 questions, each with 5 responses ranging from 1 to 5, evaluating self-reported fatigue symptoms over the past 7 days. The total score is the sum of all questions which is then converted into a pro-rated T-score with a mean of 50 and standard deviation of 10, with a possible range of 33.1 to 77.8. Higher scores indicate more fatigue. Change is defined as value at one year - value at baseline. Positive change from baseline indicates increased fatigue at one year.

Quality Adjusted Life Years (QALYs)

Correlation Between PROMIS Fatigue Score Change and Plasma Cytokine Change

Full Information

NCT ID

NCT00936390

First Posted

July 8, 2009

Last Updated

September 22, 2023

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI), NRG Oncology

1. Study Identification

Unique Protocol Identification Number

NCT00936390

Brief Title

Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer

Official Title

A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 2009 (undefined)

Primary Completion Date

October 3, 2020 (Actual)

Study Completion Date

October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI), NRG Oncology

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without androgen-deprivation therapy in treating patients with prostate cancer. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.

Detailed Description

OBJECTIVES: Primary Demonstrate an overall survival (OS) advantage in patients with intermediate-risk prostate cancer treated with dose-escalated radiotherapy (RT) with versus without short-term androgen-deprivation therapy (ADT). Secondary Determine whether the addition of ADT to dose-escalated RT versus RT alone improves clinical failures, biochemical failure by the "nadir +2", freedom from failure, rate of salvage ADT, and prostate cancer-specific mortality in these patients. Estimate the magnitude of benefit of ADT with respect to OS in patients treated with different RT modalities (i.e., external-beam radiation therapy alone vs low-dose rate brachytherapy boost vs high-dose rate brachytherapy boost). Compare acute and late treatment adverse events of these regimens and correlate these events with the presence or absence of pre-existing comorbidity as documented by the Adult Comorbidity Evaluation 27 assessment. OUTLINE: This is a multicenter, dose-escalation study of radiotherapy. Patients are stratified according to number of risk factors (1 vs 2-3), comorbidity (ACE-27 grade ≥ 2 vs < 2), and radiotherapy (RT) modality (dose-escalated external-beam RT [EBRT] vs EBRT and low-dose rate brachytherapy boost vs EBRT and high-dose rate brachytherapy boost). Patients are randomized to 1 of 2 treatment arms. After completion of study therapy, patients are followed up periodically.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1538 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose-Escalated Radiation Therapy Alone

Arm Type

Active Comparator

Arm Description

Radiation therapy consists of 79.2 Gy EBRT only or 45 Gy EBRT followed by low- or high-dose rate brachytherapy. EBRT is delivered in 1.8 Gy daily fractions.

Arm Title

Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

bicalutamide

Intervention Description

Administered orally at a dose of one 50 mg tablet per day, beginning within (before, same day as, or after) 10 days of the date of the first LHRH agonist (antagonist) therapy administration and continuing for a total duration of 6 months.

Intervention Type

Drug

Intervention Name(s)

flutamide

Other Intervention Name(s)

anti-androgen therapy

Intervention Description

Administered orally at a dose of 250 mg (two 125-mg capsules) three times a day for a total daily dose of 750 mg, beginning within (before, same day as, or after) 10 days of with the date of the first LHRH agonist (antagonist) therapy administration and continuing for a total duration of 6 months.

Intervention Type

Drug

Intervention Name(s)

LHRH agonist (antagonist) therapy

Other Intervention Name(s)

leuprolide, goserelin, buserelin, triptorelin, degarelix

Intervention Description

LHRH agonist (antagonist) therapy consists of leuprolide, goserelin, buserelin, triptorelin, or degarelix. The manufacturer's instructions should be followed. The first administration occurs with the start of anti-androgen treatment 8 weeks prior to the start of RT. The total duration of LHRH agonist (antagonist) therapy is 6 months.

Intervention Type

Radiation

Intervention Name(s)

Dose-Escalated Radiation Therapy

Intervention Description

External beam radiotherapy (EBRT) as 3D Conformal Radiotherapy (3DCRT) or intensity-modulated radiation therapy (IMRT). Brachytherapy is optional, at the discretion of the treating physician. Patients treated entirely via EBRT receive 79.2 Gy delivered in 1.8 Gy fractions. Patients who receive brachytherapy as a component of their RT receive 45 Gy EBRT in 1.8 Gy fractions. Low-dose brachytherapy boost occurs following the EBRT portion of treatment no more than 4 weeks following its completion.High-dose rate brachytherapy boost is delivered in 2 fractions separated by a minimum time span of 6 hours and the implant(s) may be performed during the EBRT portion of the treatment or within 1 week prior to its initiation or following its completion.

Primary Outcome Measure Information:

Title

Percentage of Participants Alive (Overall Survival)

Description

Time Frame

From randomization to last follow-up. Follow-up schedule: end of RT (2nd arm only), then every 3 months for a year, every 4 months for 4 years, then yearly. Maximum follow-up at time of analysis was 10.3 years. Five-year rates reported here.

Secondary Outcome Measure Information:

Title

Percentage of Participants With Biochemical Failure

Description

Time Frame

Title

Percentage of Participants With Local Recurrence

Description

Time Frame

Title

Percentage of Participants With Regional Recurrence

Description

Time Frame

From randomization to last follow-up. Maximum follow-up at time of analysis was 10.3 years.

Title

Percentage of Participants With Distant Metastasis

Description

Time Frame

Title

Percentage of Participants Dead Due to Prostate Cancer (Prostate Cancer-specific Mortality)

Description

Time Frame

Title

Percentage of Participants Dead Due to Cause Other Than Prostate Cancer (Non-Prostate Cancer-specific Mortality)

Description

Time Frame

Title

Percentage of Participants Receiving Salvage Androgen Deprivation Therapy (ADT)

Description

Time Frame

Title

Percentage of Participants Alive (Overall Survival) by Radiation Therapy Modality

Description

Time Frame

Title

Number of Participants With Acute Adverse Events

Description

Time Frame

Title

Percentage of Participants With Late Grade 3+ Adverse Events

Description

Time Frame

Title

Percentage of Participants Failed (Freedom From Failure)

Description

Time Frame

Title

Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Urinary Domain Score

Description

Time Frame