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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, Supportive care, TreatmentActive18 and overNCI, OtherRTOG 1115
CDR0000727326, NCI-2012-00700, NCT01546987

Trial Description


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.

Further Study Information



  • To evaluate the difference in overall survival of patients with clinically localized prostate cancer with unfavorable prognostic features between a) standard treatment (androgen-deprivation therapy [ADT] + radiotherapy) and b) standard treatment with the addition of 24 months of steroid 17alpha-monooxygenase TAK-700 (TAK-700).


  • To characterize differences between the treatment groups with respect to incidence of unexpected grade ≥ 3 adverse events and/or clinically significant decrement in patient-reported quality of life (QOL) among subjects treated with TAK-700.
  • To compare rates and cumulative incidence of biochemical control (freedom from PSA failure), local/regional progression, and distant metastases.
  • To compare rate and cumulative incidence of clinical failure, defined as prostate-specific antigen (PSA) > 25 ng/mL, documented local disease progression, regional or distant metastasis, or initiation of ADT.
  • To compare prostate cancer-specific survival and other-cause mortality.
  • To compare the change in severity of fatigue as measured by the Patient-Reported Outcome Measurement Information System (PROMIS) fatigue short form.
  • To compare changes in patient-reported QOL as measured by Expanded Prostate Cancer Index Composite (EPIC).
  • To assess quality-adjusted survival using the EQ-5D.
  • To compare nadir and average serum testosterone at 12 and 24 months during treatment.
  • To compare changes in hemoglobin A1C, fasting glucose, and fasting insulin during 24 months of systemic treatment and during the first three years of follow-up.
  • To compare changes in fasting lipid levels during 24 months of treatment and during the first three years of follow-up.
  • To compare changes in body mass index (BMI) during 24 months of treatment and during the first three years of follow-up.
  • To compare the incidence of adverse events ascertained via CTCAE version 4.
  • To compare the rate of recovery of testosterone to > 230 ng/dL (accepted threshold for supplementation) after 12 and 24 months of follow-up.
  • To compare the median time to recovery of testosterone to > 230 ng/dL during the first five years of follow-up.
  • To assess 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.

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to risk group (see Disease Characteristics) and type of radiation therapy (RT) boost (intensity-modulated RT (IMRT) vs brachytherapy). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive standard androgen suppression (AS) with a luteinizing hormone-releasing hormone (LHRH) 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).
  • Arm II: Patients receive the same standard AS with LHRH agonist and oral antiandrogen as in arm 1. Patients also receive steroid 17alpha-monooxygenase TAK-700 (TAK-700) PO twice daily (BID) for 2 years.

In both arms, patients undergo IMRT or 3D-conformal RT to the whole pelvis once daily, 5 days a week, for 6-8 weeks. Some patients also receive brachytherapy.

Quality of life is assessed via the Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Scale, the Expanded Prostate Cancer Index Composite (EPIC-26), and the EuroQol (EQ-5D) assessments at baseline and periodically during the study.

Serum may be collected from some patients for correlative studies.

After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter.

Eligibility Criteria


  • 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


  • 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


  • 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

National Cancer Institute

NRG Oncology Foundation, Inc.

M. Dror MichaelsonPrincipal Investigator

Trial Sites

 Kirklin Clinic at Acton Road
 Michael C Dobelbower Ph: 205-934-0309
 UAB Comprehensive Cancer Center
 Michael C Dobelbower Ph: 205-934-0309
 Auburn Radiation Oncology
 Christopher Jones Ph: 916-454-6500
  Cameron Park
 Radiation Oncology Centers - Cameron Park
 Christopher Jones Ph: 916-454-6500
 Mercy Cancer Center at Mercy San Juan Medical Center
 Christopher Jones Ph: 916-454-6500
  Los Angeles
 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
 Howard Mark Sandler Ph: 310-423-8965
 USC/Norris Comprehensive Cancer Center and Hospital
 Leslie Ballas Ph: 323-865-0451
 Leslie Ballas Ph: 323-865-0451
  Rohnert Park
 Rohnert Park Cancer Center
 Samantha A Seaward Ph: 626-564-3455
 Radiation Oncology Center - Roseville
 Christopher Jones Ph: 916-454-6500
 Sutter Cancer Center
 Christopher Jones Ph: 916-454-6500
  Santa Clara
 Kaiser Permanente Medical Center - Santa Clara Homestead Campus
 Samantha A Seaward Ph: 626-564-3455
  South San Francisco
 Kaiser Permanente Cancer Treatment Center
 Samantha A Seaward Ph: 626-564-3455
 Stanford Cancer Center
 Mark K Buyyounouski Ph: 650-498-7061
 Solano Radiation Oncology Center
 Christopher Jones Ph: 916-454-6500
 Sutter Solano Medical Center
 Ari D Baron Ph: 415-600-1182
 Helen F. Graham Cancer Center at Christiana Hospital
 Adam Raben Ph: 302-733-6227
 Adam Raben Ph: 302-733-6227
  Deerfield Beach
 University of Miami/Deerfield Beach
 Adrian S Ishkanian Ph: 866-574-5124
 University of Miami Sylvester Comprehensive Cancer Center - Miami
 Adrian S Ishkanian Ph: 866-574-5124
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Robert J Sollaccio Ph: 407-303-5623
 Winship Cancer Institute of Emory University
 Ashesh B. Jani Ph: 404-778-1868
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Samir Narayan Ph: 734-712-3456
 Louis A. Weiss Memorial Hospital
 Keith L. Shulman Ph: 773-564-5044
 OSF St. Francis Medical Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Mark C Smith Ph: 800-237-1225
  Baton Rouge
 Mary Bird Perkins Cancer Center - Baton Rouge
 Robert W Veith Ph: 504-568-2428
  New Orleans
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Troy G. Scroggins Ph: 888-562-4763
 Touro Infirmary
 Robert W Veith Ph: 504-568-2428
 Maine Medical Center- Scarborough Campus
 Ian J Bristol Ph: 207-396-8090
 St. Agnes Hospital Cancer Center
 Richard S. Hudes Ph: 410-368-2910
 Beth Israel Deaconess Medical Center
 M. Dror Michaelson Ph: 877-726-5130
 Dana-Farber/Brigham and Women's Cancer Center
 M. Dror Michaelson Ph: 877-726-5130
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 M. Dror Michaelson Ph: 877-726-5130
 Massachusetts General Hospital
 M. Dror Michaelson Ph: 877-726-5130
 Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
 M. Dror Michaelson Ph: 877-726-5130
 NSMC Cancer Center - Peabody
 M. Dror Michaelson Ph: 877-726-5130
  South Weymouth
 Dana-Farber/Brigham and Women's Cancer Center at South Shore
 M. Dror Michaelson Ph: 877-726-5130
 Hickman Cancer Center at Bixby Medical Center
 Rex B Mowat Ph: 517-265-0116
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Samir Narayan Ph: 734-712-3456
 University of Michigan Comprehensive Cancer Center
 Daniel A Hamstra Ph: 734-936-4300
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
 Sparrow Regional Cancer Center
 Samir Narayan Ph: 734-712-3456
  Royal Oak
 William Beaumont Hospital - Royal Oak Campus
 Jason M Hafron Ph: 248-786-0467
 William Beaumont Hospital - Troy Campus
 Jason M Hafron Ph: 248-786-0467
 MeritCare Bemidji
 Preston D. Steen Ph: 701-234-6161
 St. Luke's Hospital Cancer Care Center
 Steven R Bonin Ph: 888-823-5923
  Cape Girardeau
 Southeast Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Saint Louis
 Barnes-Jewish West County Hospital
 Jeff M. Michalski Ph: 800-600-3606
 David C. Pratt Cancer Center at St. John's Mercy
 Jay W Carlson Ph: 800-821-7532
 Missouri Baptist Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Jeff M. Michalski Ph: 800-600-3606
 St. John's Regional Health Center
 Jay W Carlson Ph: 800-821-7532
New Hampshire
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Alan C. Hartford Ph: 800-639-6918
North Dakota
 Medcenter One Hospital Cancer Care Center
 Preston D. Steen Ph: 701-234-6161
 Roger Maris Cancer Center at MeritCare Hospital
 Preston D. Steen Ph: 701-234-6161
 McDowell Cancer Center at Akron General Medical Center
 Mitchell Lee Fromm Ph: 330-344-6348
 Geauga Regional Hospital
 Matthew M. Cooney Ph: 800-641-2422
 Case Comprehensive Cancer Center
 Matthew M. Cooney Ph: 800-641-2422
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 Douglas David Martin Ph: 866-627-7616
 Mercy Cancer Center - Elyria
 Matthew M. Cooney Ph: 800-641-2422
 Lake/University Ireland Cancer Center
 Matthew M. Cooney Ph: 800-641-2422
  Middleburg Heights
 Southwest General Health Center
 Matthew M. Cooney Ph: 800-641-2422
  Orange Village
 UHHS Chagrin Highlands Medical Center
 Matthew M. Cooney Ph: 800-641-2422
 Robinson Radiation Oncology
 Mitchell Lee Fromm Ph: 330-344-6348
 University Hospitals Ireland Cancer Center at Firelands Regional Medical Center
 Matthew M. Cooney Ph: 800-641-2422
 Flower Hospital Cancer Center
 Rex B Mowat Ph: 517-265-0116
 UHHS Westlake Medical Center
 Matthew M. Cooney Ph: 800-641-2422
 Regional Cancer Center - Erie
 Andrew T Figura Ph: 814-838-0448
 Adams Cancer Center
 Amit B. Shah Ph: 877-441-7957
 Cherry Tree Cancer Center
 Amit B. Shah Ph: 877-441-7957
 Cancer Center of Paoli Memorial Hospital
 Albert S DeNittis Ph: 866-225-5654
 Fox Chase Cancer Center - Philadelphia
 Eric Horwitz Ph: 215-728-4790
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Robert B Den Ph: 215-955-6084
 Lankenau Cancer Center at Lankenau Hospital
 Albert S DeNittis Ph: 866-225-5654
 WellSpan Health
 Amit B. Shah Ph: 877-441-7957
South Carolina
 Hollings Cancer Center at Medical University of South Carolina
 David T Marshall Ph: 843-792-9321
 Gibbs Cancer Center-Pelham
 Patricia C Griffin Ph: 800-486-5941
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 Patricia C Griffin Ph: 800-486-5941
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Michael J Swartz Ph: 605-716-3982
 Texas Oncology, PA at Harris Center HEB
 Vivek S Kavadi Ph: 281-277-5200
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Dong W Kim Ph: 214-648-7097
  Fort Worth
 Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
 Vivek S Kavadi Ph: 281-277-5200
 University of Texas Medical Branch
 Todd A Swanson Ph: 409-772-1950
 Memorial Hermann Hospital - Memorial City
 Vivek S Kavadi Ph: 281-277-5200
  League City
 UTMB Cancer Center at Victory Lakes
 Todd A Swanson Ph: 409-772-1950
 Texas Oncology, PA at Texas Cancer Center - Sherman
 Vivek S Kavadi Ph: 281-277-5200
  Sugar Land
 Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
 Vivek S Kavadi Ph: 281-277-5200
 Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
 R. Jeffrey Lee Ph: 801-507-3950
  Saint George
 Dixie Regional Medical Center - East Campus
 R. Jeffrey Lee Ph: 801-507-3950
  Salt Lake City
 Utah Cancer Specialists at UCS Cancer Center
 R. Jeffrey Lee Ph: 801-507-3950
 Blue Ridge Cancer Care - Roanoke
 Vivek S Kavadi Ph: 281-277-5200
  Federal Way
 St. Francis Hospital
 Huong T. Pham Ph: 800-354-9527
 CCOP - Virginia Mason Research Center
 Huong T. Pham Ph: 800-354-9527
  Green Bay
 St. Mary's Hospital Medical Center - Green Bay
 James L Leenstra Ph: 920-433-8889
 St. Vincent Hospital Regional Cancer Center
 James L Leenstra Ph: 920-433-8889
  La Crosse
 Gundersen Lutheran Center for Cancer and Blood
 Kurt Oettel Ph: 608-775-2385
 Bay Area Cancer Care Center at Bay Area Medical Center
 James L Leenstra Ph: 920-433-8889
 All Saints Cancer Center at Wheaton Franciscan Healthcare
 James H. Taylor Ph: 414-874-4541
  Sturgeon Bay
 Door County Cancer Center at Door County Memorial Hospital
 James L Leenstra Ph: 920-433-8889

Link to the current record.
NLM Identifer NCT01546987 processed this data on July 09, 2014

Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to

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