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Hormone Therapy, Radiation Therapy, and Steroid 17alpha-monooxygenase TAK-700 in Treating Patients With High-Risk Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01546987
First Posted: March 7, 2012
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
  Purpose

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as steroid 17alpha-monooxygenase TAK-700, when used with other hormone therapy, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for prostate cancer when combined with hormone therapy. Studying quality-of-life in patients having cancer treatment may help identify the intermediate- and long-term effects of treatment on patients with prostate cancer.

PURPOSE: This randomized phase III trial is studying the use of hormone therapy, including TAK-700, together with radiation therapy in treating patients with prostate cancer.


Condition Intervention Phase
Prostate Cancer Drug: bicalutamide Drug: buserelin Drug: flutamide Drug: goserelin acetate Drug: leuprolide acetate Drug: orteronel Drug: triptorelin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Trial of Dose Escalated Radiation Therapy and Standard Androgen Deprivation Therapy (ADT) With a GNRH Agonist vs. Dose Escalated Radiation Therapy and Enhanced ADT With a GNRH Agonist and TAK-700 For Men With High Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Overall survival [ Time Frame: From the date of randomization to the date of death due to any cause. ]

Secondary Outcome Measures:
  • Incidence of unexpected grade ≥ 3 adverse events and/or clinically significant decrement in patient-reported quality of life (PR-QOL) among patients treated with TAK-700 [ Time Frame: From the date of randomization to the date of first documented AE ≥ grade 3 and/or to the date of first clinically significant decrement in patient-reported quality of life (PR-QOL) among patients treated with TAK-700. ]
  • Rates and cumulative incidence of biochemical control - freedom from PSA failure [ Time Frame: From the date of randomization to the date of first documented biochemical failure by the Phoenix definition (PSA ≥ 2 ng/ml over the nadir PSA) or the initiation of salvage androgen deprivation therapy. ]
  • General clinical treatment failure-free interval [ Time Frame: From the date of randomization to the date of first documented general clinical treatment failure defined as: PSA > 25 ng/ml or documented local disease progression or regional or distant metastasis or initiation of androgen deprivation therapy. ]
  • Prostate cancer-specific survival and other-cause survival [ Time Frame: From the date of randomization to the date of death due to prostate cancer for prostate cancer-specific survival and to the date of death due to other causes for other-cause survival. ]
  • Change in fatigue from baseline to 1 year, as measured by PROMIS [ Time Frame: One year from the date of randomization. ]
  • Changes in PR-QOL as measured by EPIC [ Time Frame: From the date of randomization to the week prior to RT start, to the last week of RT and 1 year and 2.5 years after the initiation of therapy. ]
  • Assessment of quality-adjusted survival using the EQ-5D [ Time Frame: From the date of randomization to the week prior to RT start, to the last week of RT and 1 year and 2.5 years after the initiation of therapy. ]
  • Nadir and average serum testosterone at 12 and 24 months during treatment [ Time Frame: From baseline to 12 months and 24 months of treatment. ]
  • Lipid profiles at 12 and 24 months [ Time Frame: From baseline to 12 months and 24 months. ]
  • Fasting plasma glucose, fasting plasma insulin, and hemoglobin A1c at 12 and 24 months [ Time Frame: From baseline to 12 months and 24 months. ]
  • Changes in body mass index (BMI) during 24 months of treatment and during the first three years of follow-up [ Time Frame: From baseline to 2 years from the start of treatment and after that every year for 3 more years. ]
  • Incidence of adverse events ascertained via Common Toxicity Criteria for Adverse Effects (CTCAE) version 4 [ Time Frame: From the start of therapy to 6 months of follow-up. ]
  • Rate of recovery of testosterone to > 230 ng/dL (accepted threshold for supplementation) after 12 and 24 months of follow-up [ Time Frame: From the treatment end date to the date when testosterone levels first recovered to > 230 ng/dl within 12 months and 24 months of treatment. ]
  • Median time to recovery of testosterone to > 230 ng/dL during the first five years of follow-up [ Time Frame: From the date of ranomization to the post-treatment end date when testosterone levels first recovered to > 230 ng/dl within 5 years after treatment. ]
  • Cumulative incidence of relevant clinical survivorship endpoints including new diagnosis of type 2 diabetes, coronary artery disease, myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis, or osteoporotic fracture [ Time Frame: From the date of randomization to the date of first reported new incidence of any of the above mentioned clinical endpoints. ]
  • Rates and cumulative incidence of local/regional progression [ Time Frame: From the date of randomization to the date of the documented presence of local/regional recurrence. ]
  • Rates and cumulative incidence of distant metastases [ Time Frame: From the date of randomization to the date of documented distant recurrence. ]

Enrollment: 239
Actual Study Start Date: May 2012
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ADT + GnRH agonist + dose escalated radiation
Patients receive standard androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) agonist (such as leuprolide, goserelin, buserelin, or triptorelin) for 24 months from initiation and oral (PO) antiandrogen (such as flutamide or bicalutamide) beginning 2 months prior and for the duration of radiation therapy (RT).
Drug: bicalutamide
Given orally
Drug: buserelin
Given subcutaneously or intramuscularly
Drug: flutamide
Given orally
Drug: goserelin acetate
Given subcutaneously or intramuscularly
Drug: leuprolide acetate
Given subcutaneously or intramuscularly
Drug: triptorelin
Given subcutaneously or intramuscularly
Experimental: ADT + GnRH agonist + dose escalated radiation + TAK-700
Patients receive the same standard ADT with a GnRH agonist and oral antiandrogen. In addition, patients also receive steroid 17alpha-monooxygenase TAK-700 (TAK-700) PO twice daily (BID) for 2 years.
Drug: bicalutamide
Given orally
Drug: buserelin
Given subcutaneously or intramuscularly
Drug: flutamide
Given orally
Drug: goserelin acetate
Given subcutaneously or intramuscularly
Drug: leuprolide acetate
Given subcutaneously or intramuscularly
Drug: orteronel
Given orally
Drug: triptorelin
Given subcutaneously or intramuscularly

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days prior to registration at high risk for recurrence as determined by one of the following combinations (risk group):

    • Gleason Score (GS) ≥ 9, PSA ≤ 150 ng/mL, any T stage
    • GS ≥ 8, PSA < 20 ng/mL, T stage ≥ T2
    • GS ≥ 8, PSA ≥ 20-150 ng/mL, any T stage
    • GS ≥ 7, PSA ≥ 20-150 ng/mL, any T stage
  • Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech), obtained prior to any luteinizing hormone-releasing hormone (LHRH) agonist or antiandrogen therapy, within 180 days of randomization
  • Androgen deprivation therapy (ADT), such as LHRH agonists (e.g., goserelin, leuprolide), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., diethyl- stilbestrol [DES]), or surgical castration (orchiectomy), may have been started prior to registration, provided that registration is within 50 days of beginning ADT; please note: if the patient has started ADT he will not be eligible to participate in the quality of life component of this study
  • Clinically negative lymph nodes as established by imaging (abdominal and/or pelvic CT or abdominal and/or pelvic MRI), nodal sampling, or dissection within 90 days prior to registration

    • Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are < 2.0 cm
  • No distant metastases (M0) on bone scan within 90 days prior to registration

    • Equivocal bone scan findings are allowed if plain films are negative for metastasis
    • No definite evidence of metastatic disease
  • Any patient undergoing brachytherapy must have transrectal ultrasound confirmation of prostate volume < 60 cc, American Urological Association (AUA) 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 external-beam radiotherapy (EBRT) only

PATIENT CHARACTERISTICS:

  • Height, weight, Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) ≥ 1,800 cells/mm^3
  • Platelets ≥ 100,000 cells/mm^3
  • Hemoglobin ≥ 8.0 g/dL (The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable)
  • Serum creatinine < 2.0 mg/dL
  • Creatinine clearance > 40 mL/minute
  • Bilirubin < 1.5 x upper limit of normal (ULN)
  • Alanine aminotranserase (ALT) or aspartate aminotransferase (AST) < 2.5 x ULN
  • No PSA > 150 ng/mL
  • Screening calculated ejection fraction ≥ ULN by multiple-gated acquisition (MUGA) scan or by echocardiogram
  • Androgen deprivation therapy (ADT), such as LHRH agonists (e.g., goserelin, leuprolide), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical castration (orchiectomy) may have been started prior to registration, provided that registration is within 50 days of beginning ADT.
  • Patients, even if surgically sterilized (i.e., status post vasectomy), must agree to practice effective barrier contraception during the entire study treatment period and for 4 months (120 days) after the last dose of study drug
  • No prior invasive malignancy (except non-melanoma skin cancer) unless disease-free or not requiring systemic therapy for a minimum of 3 years
  • No known hypersensitivity to TAK-700 or related compounds
  • No history of adrenal insufficiency
  • No history of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of grade > 2 (NCI CTCAE, version 4.02) thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g., pericardial effusion restrictive cardiomyopathy) within 6 months prior to registration

    • Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed
  • No New York Heart Association Class III or IV heart failure
  • No ECG abnormalities of Q-wave infarction, unless identified 6 or more months prior to screening, or corrected QT (QTc) interval > 460 msec
  • No prior allergic reaction to the drugs involved in this protocol
  • No Cushing syndrome
  • No severe chronic renal disease or chronic liver disease
  • No uncontrolled hypertension despite appropriate medical therapy within 21 days prior to registration (blood pressure of greater than 150 mm Hg systolic and 90 mm Hg diastolic at 2 separate measurements no more than 60 minutes apart during screening visit)
  • No serious infection within 14 days prior to registration
  • No uncontrolled nausea, vomiting, or diarrhea (CTCAE grade ≥ 3) despite appropriate medical therapy at the time of registration
  • No known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-700, including difficulty swallowing tablets

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior testosterone administration is allowed if last administered at least 90 days prior to registration
  • No prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason
  • No prior systemic chemotherapy for prostate cancer

    • Prior chemotherapy for a different cancer is allowed
  • No prior radiotherapy, including brachytherapy, to the region of the prostate that would result in overlap of radiation therapy fields
  • No previous hormonal therapy for > 50 days
  • No chronic treatment with glucocorticoids within one year
  • No major surgery within 14 days prior to registration
  • No other investigational agent
  • No other anticancer therapy
  • No concurrent hormonal therapies including estrogens or herbal products
  • No concurrent ketoconazole or aminoglutethimide
  • No chronic use of systemic corticosteroids, such as oral prednisone
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01546987


  Hide Study Locations
Locations
United States, Alabama
The Kirklin Clinic at Acton Road
Birmingham, Alabama, United States, 35243
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Arizona Oncology-Deer Valley Center
Phoenix, Arizona, United States, 85027
Arizona Oncology Services Foundation
Scottsdale, Arizona, United States, 85260
United States, California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States, 95603
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States, 95682
Mercy San Juan Medical Center
Carmichael, California, United States, 95608
Veterans Administration Long Beach Medical Center
Long Beach, California, United States, 90822
Los Angeles County-USC Medical Center
Los Angeles, California, United States, 90033
University of Southern California/Norris Cancer Center
Los Angeles, California, United States, 90033
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Pomona Valley Hospital Medical Center
Pomona, California, United States, 91767
Rohnert Park Cancer Center
Rohnert Park, California, United States, 94928
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States, 95661
Sutter General Hospital
Sacramento, California, United States, 95816
University of California At San Diego
San Diego, California, United States, 92103
UCSF-Mount Zion
San Francisco, California, United States, 94115
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, United States, 94080
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, United States, 95687
Sutter Solano Medical Center
Vallejo, California, United States, 94589
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Poudre Valley Radiation Oncology
Fort Collins, Colorado, United States, 80528
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
William Backus Hospital
Norwich, Connecticut, United States, 06360
United States, Delaware
Helen F Graham Cancer Center
Newark, Delaware, United States, 19713
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Florida Hospital
Orlando, Florida, United States, 32803
United States, Georgia
Grady Health System
Atlanta, Georgia, United States, 30303
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
Saint Joseph's-Candler Health System
Savannah, Georgia, United States, 31405
United States, Hawaii
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
United States, Idaho
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
Idaho Urologic Institute PA
Meridian, Idaho, United States, 83642
United States, Illinois
Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Hines Veterans Administration Hospital
Hines, Illinois, United States, 60141
Loyola University Medical Center
Maywood, Illinois, United States, 60153
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
United States, Indiana
Radiation Oncology Associates PC
Fort Wayne, Indiana, United States, 46804
Parkview Hospital Randallia
Fort Wayne, Indiana, United States, 46805
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Kansas City Cancer Centers-Southwest
Overland Park, Kansas, United States, 66210
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Touro Infirmary
New Orleans, Louisiana, United States, 70115
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
United States, Maine
Maine Medical Center- Scarborough Campus
Scarborough, Maine, United States, 04074
United States, Maryland
Saint Agnes Hospital
Baltimore, Maryland, United States, 21229
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Saint Anne's Hospital
Fall River, Massachusetts, United States, 02721
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Milford, Massachusetts, United States, 01757
North Shore Medical Center Cancer Center
Peabody, Massachusetts, United States, 01960
Dana-Farber/Brigham and Women's Cancer Center at South Shore
South Weymouth, Massachusetts, United States, 02190
United States, Michigan
Bixby Medical Center
Adrian, Michigan, United States, 49221
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
University of Michigan
Ann Arbor, Michigan, United States, 48109
McLaren-Flint
Flint, Michigan, United States, 48532
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Great Lakes Cancer Institute-Lapeer Campus
Lapeer, Michigan, United States, 48446
McLaren Cancer Institute-Owosso
Owosso, Michigan, United States, 48867
Northern Michigan Regional Hospital
Petoskey, Michigan, United States, 49770
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital - Troy
Troy, Michigan, United States, 48098
United States, Minnesota
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States, 56601
Saint Luke's Hospital of Duluth
Duluth, Minnesota, United States, 55805
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United States, Missouri
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
Kansas City Cancer Center - South
Kansas City, Missouri, United States, 64131
Kansas City Cancer Centers - North
Kansas City, Missouri, United States, 64154
Kansas City Cancer Center-Lee's Summit
Lee's Summit, Missouri, United States, 64064
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center-South County
Saint Louis, Missouri, United States, 63129
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Barnes-Jewish West County Hospital
Saint Louis, Missouri, United States, 63141
Saint John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
Siteman Cancer Center - Saint Peters
Saint Peters, Missouri, United States, 63376
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
United States, Montana
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
The Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Hampshire
Concord Hospital
Concord, New Hampshire, United States, 03301
Exeter Hospital
Exeter, New Hampshire, United States, 03833
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Elliot Hospital
Manchester, New Hampshire, United States, 03103
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees, New Jersey, United States, 08043
United States, North Dakota
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Sanford Medical Center-Fargo
Fargo, North Dakota, United States, 58122
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Akron General Medical Center
Akron, Ohio, United States, 44307
Summa Barberton Hospital
Barberton, Ohio, United States, 44203
Geaugra Hospital
Chardon, Ohio, United States, 44024
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Mercy Cancer Center-Elyria
Elyria, Ohio, United States, 44035
Summa Health Center at Lake Medina
Medina, Ohio, United States, 44256
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
Southwest General Health Center Ireland Cancer Center
Middleburg Heights, Ohio, United States, 44130
UHHS-Chagrin Highlands Medical Center
Orange, Ohio, United States, 44122
Robinson Radiation Oncology
Ravenna, Ohio, United States, 44266
Ireland Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
Flower Hospital
Sylvania, Ohio, United States, 43560
UHHS-Westlake Medical Center
Westlake, Ohio, United States, 44145
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Rogue Valley Medical Center
Medford, Oregon, United States, 97504
United States, Pennsylvania
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
The Regional Cancer Center
Erie, Pennsylvania, United States, 16505
Adams Cancer Center
Gettysburg, Pennsylvania, United States, 17325
Cherry Tree Cancer Center
Hanover, Pennsylvania, United States, 17331
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Reading Hospital
West Reading, Pennsylvania, United States, 19611
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
WellSpan Health-York Hospital
York, Pennsylvania, United States, 17405
United States, South Carolina
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States, 29651
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Lexington Medical Center
West Columbia, South Carolina, United States, 29169
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
United States, Texas
Texas Oncology PA - Bedford
Bedford, Texas, United States, 76022
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
The Klabzuba Cancer Center
Fort Worth, Texas, United States, 76104
University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555-0565
Memorial Hermann Memorial City Medical Center
Houston, Texas, United States, 77024
M D Anderson Cancer Center
Houston, Texas, United States, 77030
UTMB Cancer Center at Victory Lakes
League City, Texas, United States, 77573
Texas Cancer Center-Sherman
Sherman, Texas, United States, 75090
Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, United States, 77479
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
Dixie Medical Center Regional Cancer Center
Saint George, Utah, United States, 84770
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, United States, 84106
United States, Virginia
Sentara Cancer Institute at Sentara CarePlex Hospital
Hampton, Virginia, United States, 23666
Sentara Hospitals
Norfolk, Virginia, United States, 23507
Oncology and Hematology Associates of Southwest Virginia
Roanoke, Virginia, United States, 24014
Sentara Virginia Beach General Hospital
Virginia Beach, Virginia, United States, 23454
United States, Washington
Saint Francis Hospital
Federal Way, Washington, United States, 98003
Virginia Mason CCOP
Seattle, Washington, United States, 98101
United States, Wisconsin
Appleton Medical Center
Appleton, Wisconsin, United States, 54911
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Gundersen Lutheran
La Crosse, Wisconsin, United States, 54601
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, United States, 53097
Columbia Saint Mary's Water Tower Medical Commons
Milwaukee, Wisconsin, United States, 53211
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Clement J. Zablocki VA Medical Center
Milwaukee, Wisconsin, United States, 53295
Wheaton Franciscan Cancer Care - All Saints
Racine, Wisconsin, United States, 53405
Door County Cancer Center
Sturgeon Bay, Wisconsin, United States, 54235-1495
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
BCCA-Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Canada, Ontario
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Ottawa Health Research Institute-General Division
Ottawa, Ontario, Canada, K1H 1C4
Canada, Quebec
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
NRG Oncology
Investigators
Principal Investigator: M. Dror Michaelson, MD, PhD Massachusetts General Hospital
  More Information

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01546987     History of Changes
Other Study ID Numbers: RTOG 1115
CDR0000727326
NCI-2012-00700 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: March 3, 2012
First Posted: March 7, 2012
Last Update Posted: May 19, 2017
Last Verified: May 2017

Keywords provided by Radiation Therapy Oncology Group:
adenocarcinoma of the prostate
stage I prostate cancer
stage IIA prostate cancer
stage IIB prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Buserelin
Goserelin
Triptorelin Pamoate
Flutamide
Bicalutamide
Deslorelin
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents