New drug combo aims to boost radiation success in aggressive prostate cancer

NCT ID NCT01546987

Disease control Sponsor: Radiation Therapy Oncology Group Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested whether adding the drug TAK-700 to standard hormone therapy and radiation could better control high-risk prostate cancer. 239 men participated. The study compared standard treatment (GnRH agonist plus anti-androgen) with an enhanced version that also included TAK-700. The goal was to see if the enhanced combo delayed cancer recurrence and improved survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: TAK-700 (orteronel) plus GnRH agonist and anti-androgen
What this could lead to: If successful, adding TAK-700 to standard hormone therapy and radiation could improve cancer control and delay recurrence in men with high-risk prostate cancer.
What could go wrong: This is a completed Phase 3 trial, but results may show no significant benefit or added side effects. The primary endpoint was changed during the study, which can affect reliability.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

239 people

The number who actually took part.

Started

May 2012

Finished

Sep 2025

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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: * 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 2. History/physical examination within 60 days prior to registration. 3. Clinically negative lymph nodes as established by imaging \[abdominal and/or pelvic computerized tomography (CT) or abdominal and/or pelvic magnetic resonance imaging (MRI)\], 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. 4. No distant metastases (M0) on bone scan within 90 days prior to registration (18F-Na bone scan is an acceptable substitute). •Equivocal bone scan findings are allowed if plain films are negative for metastasis. 5. Baseline serum prostate-specific antigen (PSA) value performed with an FDA-approved assay (e.g., Abbott, Hybritech), obtained prior to any luteinizing hormone-releasing hormone (LHRH) or anti-androgen therapy, within 180 days of randomization. 6. 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. Please note: If the patient has started ADT he will not be eligible to participate in the quality of life component of this study. 7. Prior testosterone administration is allowed if last administered at least 90 days prior to registration. 8. Zubrod Performance Status 0-1 within 21 days prior to registration 9. Age ≥ 18 10. Complete blood count (CBC)/differential obtained within 14 days prior to registration on study, with adequate bone marrow function defined as follows: * Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3 * Platelets ≥ 100,000 cells/mm3 * Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.) 11. Serum creatinine \< 2.0 mg/dl and creatinine clearance (can be calculated) \> 40 mL/minute within 21 days prior to registration 12. Bilirubin \< 1.5x upper limit of normal (ULN) and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 2.5x ULN within 21 days prior to registration 13. Serum testosterone within 21 days prior to registration 14. Chemistry (including sodium, potassium, chloride, bicarbonate (carbon dioxide), blood urea nitrogen (BUN), glucose, calcium, magnesium and phosphorous) and liver panels (including albumin and alkaline phosphatase) obtained within 21 days prior to registration 15. Fasting glucose, fasting insulin, lipid panel \[cholesterol, triglyceride, high-density lipoprotein (HDL), low-density lipoprotein (LDL)\], and Hemoglobin A1C within 21 days prior to registration 16. Screening calculated ejection fraction of ≥ to institutional lower limit of normal by multiple gated acquisition (MUGA) scan or by echocardiogram (ECHO). 17. Baseline electrocardiogram (ECG) within 180 days prior to registration 18. Patients, even if surgically sterilized (ie, status post vasectomy), who: 1. 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, or 2. Agree to completely abstain from intercourse. 19. Patient must be able to provide study-specific informed consent prior to study entry. Exclusion Criteria: 1. PSA \> 150 2. Definite evidence of metastatic disease. 3. Pathologically positive lymph nodes or nodes \> 2.0 cm on imaging. 4. Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason. 5. Prior invasive malignancy (except non-melanoma skin cancer) unless disease-free or not requiring systemic therapy for a minimum of 3 years. 6. Prior systemic chemotherapy for prostate cancer (Note that prior chemotherapy for a different cancer is allowed). 7. Prior radiotherapy, including brachytherapy, to the region of the prostate that would result in overlap of radiation therapy fields. •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 radiation therapy \[EBRT\] only). 8. Previous hormonal therapy for \> 50 days. 9. Known hypersensitivity to TAK-700 or related compounds 10. A history of adrenal insufficiency 11. History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade \> 2 \[NCI CTCAE, version 4.02\] (U.S. Department of Health and Human Services, National Institutes of Health National Cancer Institute, 2009), thromboembolic events (eg, 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. 12. New York Heart Association Class III or IV heart failure. 13. ECG abnormalities of: 1. Q-wave infarction, unless identified 6 or more months prior to screening 2. QTc interval \> 460 msec 14. Patients who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. 15. Prior allergic reaction to the drugs involved in this protocol. 16. Study entry PSA obtained during the following time frames: 1. 10-day period following prostate biopsy; 2. following initiation of hormonal therapy. 17. Cushing's syndrome 18. Severe chronic renal disease (serum creatinine \> 2.0 mg/dl and confirmed by creatinine clearance \< 40 mL/minute) 19. Chronic liver disease (bilirubin \> 1.5x ULN, ALT or AST \> 2.5x ULN) 20. Chronic treatment with glucocorticoids within one year 21. 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) 22. Unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel. 23. Major surgery within 14 days prior to registration 24. Serious infection within 14 days prior to registration 25. Uncontrolled nausea, vomiting, or diarrhea \[Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3\] despite appropriate medical therapy at the time of registration 26. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-700, including difficulty swallowing tablets

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

Adams Cancer Center

Gettysburg, Pennsylvania, 17325, United States
Akron General Medical Center

Akron, Ohio, 44307, United States
Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada
Appleton Medical Center

Appleton, Wisconsin, 54911, United States
Arizona Oncology Services Foundation

Scottsdale, Arizona, 85260, United States
Arizona Oncology-Deer Valley Center

Phoenix, Arizona, 85027, United States
Atlanta VA Medical Center

Decatur, Georgia, 30033, United States
BCCA-Cancer Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada
Barnes-Jewish West County Hospital

St Louis, Missouri, 63141, United States
Bay Area Medical Center

Marinette, Wisconsin, 54143, United States
Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, 59405, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
Bixby Medical Center

Adrian, Michigan, 49221, United States
Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States
CHUM - Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada
Case Western Reserve University

Cleveland, Ohio, 44106, United States
Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States
Cherry Tree Cancer Center

Hanover, Pennsylvania, 17331, United States
Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States
Clement J. Zablocki VA Medical Center

Milwaukee, Wisconsin, 53295, United States
Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
Columbia Saint Mary's Hospital - Ozaukee

Mequon, Wisconsin, 53097, United States
Columbia Saint Mary's Water Tower Medical Commons

Milwaukee, Wisconsin, 53211, United States
Concord Hospital

Concord, New Hampshire, 03301, United States
Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States
Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional

Milford, Massachusetts, 01757, United States
Dana-Farber/Brigham and Women's Cancer Center at South Shore

South Weymouth, Massachusetts, 02190, United States
Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States
Decatur Memorial Hospital

Decatur, Illinois, 62526, United States
Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026, United States
Dixie Medical Center Regional Cancer Center

St. George, Utah, 84770, United States
Door County Cancer Center

Sturgeon Bay, Wisconsin, 54235-1495, United States
Elliot Hospital

Manchester, New Hampshire, 03103, United States
Emory University/Winship Cancer Institute

Atlanta, Georgia, 30322, United States
Exeter Hospital

Exeter, New Hampshire, 03833, United States
Florida Hospital

Orlando, Florida, 32803, United States
Flower Hospital

Sylvania, Ohio, 43560, United States
Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States
Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Geaugra Hospital

Chardon, Ohio, 44024, United States
Gibbs Cancer Center-Pelham

Greer, South Carolina, 29651, United States
Grady Health System

Atlanta, Georgia, 30303, United States
Great Lakes Cancer Institute-Lapeer Campus

Lapeer, Michigan, 48446, United States
Gundersen Lutheran

La Crosse, Wisconsin, 54601, United States
Hartford Hospital

Hartford, Connecticut, 06102, United States
Helen F Graham Cancer Center

Newark, Delaware, 19713, United States
Hines Veterans Administration Hospital

Hines, Illinois, 60141, United States
Idaho Urologic Institute PA

Meridian, Idaho, 83642, United States
Intermountain Medical Center

Murray, Utah, 84157, United States
Ireland Cancer Center at Firelands Regional Medical Center

Sandusky, Ohio, 44870, United States
Kaiser Permanente Cancer Treatment Center

South San Francisco, California, 94080, United States
Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051, United States
Kansas City Cancer Center - South

Kansas City, Missouri, 64131, United States
Kansas City Cancer Center-Lee's Summit

Lee's Summit, Missouri, 64064, United States
Kansas City Cancer Centers - North

Kansas City, Missouri, 64154, United States
Kansas City Cancer Centers-Southwest

Overland Park, Kansas, 66210, United States
Lake University Ireland Cancer Center

Mentor, Ohio, 44060, United States
Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States
Lexington Medical Center

West Columbia, South Carolina, 29169, United States
London Regional Cancer Program

London, Ontario, N6A 4L6, Canada
Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States
Loyola University Medical Center

Maywood, Illinois, 60153, United States
M D Anderson Cancer Center

Houston, Texas, 77030, United States
MD Anderson Cancer Center at Cooper-Voorhees

Voorhees Township, New Jersey, 08043, United States
Maine Medical Center- Scarborough Campus

Scarborough, Maine, 04074, United States
Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States
Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States
McLaren Cancer Institute-Owosso

Owosso, Michigan, 48867, United States
McLaren-Flint

Flint, Michigan, 48532, United States
Memorial Hermann Memorial City Medical Center

Houston, Texas, 77024, United States
Mercy Cancer Center-Elyria

Elyria, Ohio, 44035, United States
Mercy Hospital Springfield

Springfield, Missouri, 65804, United States
Mercy San Juan Medical Center

Carmichael, California, 95608, United States
Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States
Natalie Warren Bryant Cancer Center at Saint Francis

Tulsa, Oklahoma, 74136, United States
Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States
North Shore Medical Center Cancer Center

Peabody, Massachusetts, 01960, United States
Northern Michigan Regional Hospital

Petoskey, Michigan, 49770, United States
OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States
Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States
Ohio State University Medical Center

Columbus, Ohio, 43210, United States
Oncology and Hematology Associates of Southwest Virginia

Roanoke, Virginia, 24014, United States
Ottawa Health Research Institute-General Division

Ottawa, Ontario, K1H 1C4, Canada
Paoli Memorial Hospital

Paoli, Pennsylvania, 19301, United States
Parkview Hospital Randallia

Fort Wayne, Indiana, 46805, United States
Peninsula Regional Medical Center

Salisbury, Maryland, 21801, United States
Piedmont Hospital

Atlanta, Georgia, 30309, United States
Pomona Valley Hospital Medical Center

Pomona, California, 91767, United States
Poudre Valley Radiation Oncology

Fort Collins, Colorado, 80528, United States
Queen's Medical Center

Honolulu, Hawaii, 96813, United States
Radiation Oncology Associates PC

Fort Wayne, Indiana, 46804, United States
Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States
Reading Hospital

West Reading, Pennsylvania, 19611, United States
Regions Hospital

Saint Paul, Minnesota, 55101, United States
Robinson Radiation Oncology

Ravenna, Ohio, 44266, United States
Rogue Valley Medical Center

Medford, Oregon, 97504, United States
Rohnert Park Cancer Center

Rohnert Park, California, 94928, United States
Saint Agnes Hospital

Baltimore, Maryland, 21229, United States
Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States
Saint Anne's Hospital

Fall River, Massachusetts, 02721, United States
Saint Francis Hospital

Federal Way, Washington, 98003, United States
Saint John's Mercy Medical Center

St Louis, Missouri, 63141, United States
Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106-0995, United States
Saint Joseph's-Candler Health System

Savannah, Georgia, 31405, United States
Saint Luke's Hospital of Duluth

Duluth, Minnesota, 55805, United States
Saint Mary's Hospital

Green Bay, Wisconsin, 54303, United States
Saint Peter's University Hospital

New Brunswick, New Jersey, 08901, United States
Saint Vincent Hospital

Green Bay, Wisconsin, 54301, United States
Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States
Sanford Clinic North-Bemidgi

Bemidji, Minnesota, 56601, United States
Sanford Medical Center-Fargo

Fargo, North Dakota, 58122, United States
Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada
Sentara Cancer Institute at Sentara CarePlex Hospital

Hampton, Virginia, 23666, United States
Sentara Hospitals

Norfolk, Virginia, 23507, United States
Sentara Virginia Beach General Hospital

Virginia Beach, Virginia, 23454, United States
Siteman Cancer Center - Saint Peters

City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center-South County

St Louis, Missouri, 63129, United States
Southeast Cancer Center

Cape Girardeau, Missouri, 63703, United States
Southwest General Health Center Ireland Cancer Center

Middleburg Heights, Ohio, 44130, United States
Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States
Stanford University Hospitals and Clinics

Stanford, California, 94305, United States
Summa Akron City Hospital/Cooper Cancer Center

Akron, Ohio, 44304, United States
Summa Barberton Hospital

Barberton, Ohio, 44203, United States
Summa Health Center at Lake Medina

Medina, Ohio, 44256, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, 95603, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, 95682, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, 95661, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville

Vacaville, California, 95687, United States
Sutter General Hospital

Sacramento, California, 95816, United States
Sutter Solano Medical Center

Vallejo, California, 94589, United States
Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States
Texas Cancer Center-Sherman

Sherman, Texas, 75090, United States
Texas Oncology Cancer Center Sugar Land

Sugar Land, Texas, 77479, United States
Texas Oncology PA - Bedford

Bedford, Texas, 76022, United States
The Hospital of Central Connecticut

New Britain, Connecticut, 06050, United States
The Kirklin Clinic at Acton Road

Birmingham, Alabama, 35243, United States
The Klabzuba Cancer Center

Fort Worth, Texas, 76104, United States
The Nebraska Medical Center

Omaha, Nebraska, 68198, United States
The Regional Cancer Center

Erie, Pennsylvania, 16505, United States
Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States
Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada
Touro Infirmary

New Orleans, Louisiana, 70115, United States
UCSF-Mount Zion

San Francisco, California, 94115, United States
UHHS-Chagrin Highlands Medical Center

Orange, Ohio, 44122, United States
UHHS-Westlake Medical Center

Westlake, Ohio, 44145, United States
UTMB Cancer Center at Victory Lakes

League City, Texas, 77573, United States
University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States
University of California At San Diego

San Diego, California, 92103, United States
University of Cincinnati

Cincinnati, Ohio, 45267, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States
University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States
University of Kansas Medical Center

Kansas City, Kansas, 66160, United States
University of Kentucky

Lexington, Kentucky, 40536, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States
University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Southern California/Norris Cancer Center

Los Angeles, California, 90033, United States
University of Texas Medical Branch at Galveston

Galveston, Texas, 77555-0565, United States
University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States
Utah Cancer Specialists-Salt Lake City

Salt Lake City, Utah, 84106, United States
Veterans Administration Long Beach Medical Center

Long Beach, California, 90822, United States
Virginia Mason CCOP

Seattle, Washington, 98101, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
Weiss Memorial Hospital

Chicago, Illinois, 60640, United States
WellSpan Health-York Hospital

York, Pennsylvania, 17405, United States
West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States
Wheaton Franciscan Cancer Care - All Saints

Racine, Wisconsin, 53405, United States
William Backus Hospital

Norwich, Connecticut, 06360, United States
William Beaumont Hospital - Troy

Troy, Michigan, 48098, United States
William Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073, United States

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