AzTrials
AzTrials

Prostate CancerPhase 3NCT01546987

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

A Phase 3 study testing GnRH agonist, Anti-androgen and TAK-700 in people with Prostate Cancer, run by Radiation Therapy Oncology Group at 172 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
GnRH agonist, Anti-androgen and TAK-700
Could I receive a placebo?
No, everyone receives an active treatment
How many people
239 participants
Where
172 sitesin 2 countries
Study dates
May 2012to 4 Sep 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • History/physical examination within 60 days prior to registration.
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  • 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.
  • 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.
  • 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.
  • 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.
  • Prior testosterone administration is allowed if last administered at least 90 days prior to registration.
  • Zubrod Performance Status 0-1 within 21 days prior to registration
  • Age ≥ 18
  • 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.)
  • Serum creatinine < 2.0 mg/dl and creatinine clearance (can be calculated) > 40 mL/minute within 21 days prior to registration
  • 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
  • Serum testosterone within 21 days prior to registration
  • 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
  • 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
  • Screening calculated ejection fraction of ≥ to institutional lower limit of normal by multiple gated acquisition (MUGA) scan or by echocardiogram (ECHO).
  • Baseline electrocardiogram (ECG) within 180 days prior to registration
  • Patients, even if surgically sterilized (ie, status post vasectomy), who:
  • 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
  • Agree to completely abstain from intercourse.
  • Patient must be able to provide study-specific informed consent prior to study entry.

Who cannot join

  • PSA > 150
  • Definite evidence of metastatic disease.
  • Pathologically positive lymph nodes or nodes > 2.0 cm on imaging.
  • Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason.
  • Prior invasive malignancy (except non-melanoma skin cancer) unless disease-free or not requiring systemic therapy for a minimum of 3 years.
  • Prior systemic chemotherapy for prostate cancer (Note that prior chemotherapy for a different cancer is allowed).
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  • 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).
  • Previous hormonal therapy for > 50 days.
  • Known hypersensitivity to TAK-700 or related compounds
  • A history of adrenal insufficiency
  • 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.
  • New York Heart Association Class III or IV heart failure.
  • ECG abnormalities of:
  • Q-wave infarction, unless identified 6 or more months prior to screening
  • QTc interval > 460 msec
  • 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.
  • Prior allergic reaction to the drugs involved in this protocol.
  • Study entry PSA obtained during the following time frames:
  • 10-day period following prostate biopsy;
  • following initiation of hormonal therapy.
  • Cushing's syndrome
  • Severe chronic renal disease (serum creatinine > 2.0 mg/dl and confirmed by creatinine clearance < 40 mL/minute)
  • Chronic liver disease (bilirubin > 1.5x ULN, ALT or AST > 2.5x ULN)
  • Chronic treatment with glucocorticoids within one year
  • 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)
  • Unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel.
  • Major surgery within 14 days prior to registration
  • Serious infection within 14 days prior to registration
  • Uncontrolled nausea, vomiting, or diarrhea [Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3] despite appropriate medical therapy at the time of registration
  • Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-700, including difficulty swallowing tablets

Trial locations and contacts

172 sites in 2 countries.

172 sites in 2 countries

United States165 sites

  • Bixby Medical Center

    Adrian, Michigan, 49221

  • Summa Akron City Hospital/Cooper Cancer Center

    Akron, Ohio, 44304

  • Akron General Medical Center

    Akron, Ohio, 44307

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Appleton Medical Center

    Appleton, Wisconsin, 54911

  • Grady Health System

    Atlanta, Georgia, 30303

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

  • University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • Summa Barberton Hospital

    Barberton, Ohio, 44203

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Texas Oncology PA - Bedford

    Bedford, Texas, 76022

  • Sanford Clinic North-Bemidgi

    Bemidji, Minnesota, 56601

  • The Kirklin Clinic at Acton Road

    Birmingham, Alabama, 35243

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Geaugra Hospital

    Chardon, Ohio, 44024

  • Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Siteman Cancer Center - Saint Peters

    City of Saint Peters, Missouri, 63376

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Concord Hospital

    Concord, New Hampshire, 03301

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • Saint Luke's Hospital of Duluth

    Duluth, Minnesota, 55805

  • Mercy Cancer Center-Elyria

    Elyria, Ohio, 44035

  • The Regional Cancer Center

    Erie, Pennsylvania, 16505

  • Exeter Hospital

    Exeter, New Hampshire, 03833

  • Saint Anne's Hospital

    Fall River, Massachusetts, 02721

  • Sanford Medical Center-Fargo

    Fargo, North Dakota, 58122

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • McLaren-Flint

    Flint, Michigan, 48532

  • Poudre Valley Radiation Oncology

    Fort Collins, Colorado, 80528

  • Radiation Oncology Associates PC

    Fort Wayne, Indiana, 46804

  • Parkview Hospital Randallia

    Fort Wayne, Indiana, 46805

  • The Klabzuba Cancer Center

    Fort Worth, Texas, 76104

  • University of Texas Medical Branch at Galveston

    Galveston, Texas, 77555-0565

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Sentara Cancer Institute at Sentara CarePlex Hospital

    Hampton, Virginia, 23666

  • Cherry Tree Cancer Center

    Hanover, Pennsylvania, 17331

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Hines Veterans Administration Hospital

    Hines, Illinois, 60141

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Memorial Hermann Memorial City Medical Center

    Houston, Texas, 77024

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Kansas City Cancer Center - South

    Kansas City, Missouri, 64131

  • Kansas City Cancer Centers - North

    Kansas City, Missouri, 64154

  • Gundersen Lutheran

    La Crosse, Wisconsin, 54601

  • Great Lakes Cancer Institute-Lapeer Campus

    Lapeer, Michigan, 48446

  • UTMB Cancer Center at Victory Lakes

    League City, Texas, 77573

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Kansas City Cancer Center-Lee's Summit

    Lee's Summit, Missouri, 64064

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Veterans Administration Long Beach Medical Center

    Long Beach, California, 90822

  • Los Angeles County-USC Medical Center

    Los Angeles, California, 90033

  • University of Southern California/Norris Cancer Center

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Elliot Hospital

    Manchester, New Hampshire, 03103

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Rogue Valley Medical Center

    Medford, Oregon, 97504

  • Summa Health Center at Lake Medina

    Medina, Ohio, 44256

  • Lake University Ireland Cancer Center

    Mentor, Ohio, 44060

  • Columbia Saint Mary's Hospital - Ozaukee

    Mequon, Wisconsin, 53097

  • Idaho Urologic Institute PA

    Meridian, Idaho, 83642

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • Southwest General Health Center Ireland Cancer Center

    Middleburg Heights, Ohio, 44130

  • Dana-Farber/Brigham and Women's Cancer Center at Milford Regional

    Milford, Massachusetts, 01757

  • Columbia Saint Mary's Water Tower Medical Commons

    Milwaukee, Wisconsin, 53211

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Clement J. Zablocki VA Medical Center

    Milwaukee, Wisconsin, 53295

  • Intermountain Medical Center

    Murray, Utah, 84157

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

  • Touro Infirmary

    New Orleans, Louisiana, 70115

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Sentara Hospitals

    Norfolk, Virginia, 23507

  • William Backus Hospital

    Norwich, Connecticut, 06360

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • The Nebraska Medical Center

    Omaha, Nebraska, 68198

  • UHHS-Chagrin Highlands Medical Center

    Orange, Ohio, 44122

  • Florida Hospital

    Orlando, Florida, 32803

  • Kansas City Cancer Centers-Southwest

    Overland Park, Kansas, 66210

  • McLaren Cancer Institute-Owosso

    Owosso, Michigan, 48867

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • North Shore Medical Center Cancer Center

    Peabody, Massachusetts, 01960

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Northern Michigan Regional Hospital

    Petoskey, Michigan, 49770

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Arizona Oncology-Deer Valley Center

    Phoenix, Arizona, 85027

  • Pomona Valley Hospital Medical Center

    Pomona, California, 91767

  • Wheaton Franciscan Cancer Care - All Saints

    Racine, Wisconsin, 53405

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Robinson Radiation Oncology

    Ravenna, Ohio, 44266

  • Oncology and Hematology Associates of Southwest Virginia

    Roanoke, Virginia, 24014

  • Rohnert Park Cancer Center

    Rohnert Park, California, 94928

  • Sutter Cancer Centers Radiation Oncology Services-Roseville

    Roseville, California, 95661

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • Sutter General Hospital

    Sacramento, California, 95816

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Peninsula Regional Medical Center

    Salisbury, Maryland, 21801

  • Utah Cancer Specialists-Salt Lake City

    Salt Lake City, Utah, 84106

  • University of California At San Diego

    San Diego, California, 92103

  • UCSF-Mount Zion

    San Francisco, California, 94115

  • Ireland Cancer Center at Firelands Regional Medical Center

    Sandusky, Ohio, 44870

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051

  • Saint Joseph's-Candler Health System

    Savannah, Georgia, 31405

  • Maine Medical Center- Scarborough Campus

    Scarborough, Maine, 04074

  • Arizona Oncology Services Foundation

    Scottsdale, Arizona, 85260

  • Virginia Mason CCOP

    Seattle, Washington, 98101

  • Texas Cancer Center-Sherman

    Sherman, Texas, 75090

  • Kaiser Permanente Cancer Treatment Center

    South San Francisco, California, 94080

  • Dana-Farber/Brigham and Women's Cancer Center at South Shore

    South Weymouth, Massachusetts, 02190

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Barnes-Jewish West County Hospital

    St Louis, Missouri, 63141

  • Saint John's Mercy Medical Center

    St Louis, Missouri, 63141

  • Dixie Medical Center Regional Cancer Center

    St. George, Utah, 84770

  • Stanford University Hospitals and Clinics

    Stanford, California, 94305

  • Door County Cancer Center

    Sturgeon Bay, Wisconsin, 54235-1495

  • Texas Oncology Cancer Center Sugar Land

    Sugar Land, Texas, 77479

  • Flower Hospital

    Sylvania, Ohio, 43560

  • William Beaumont Hospital - Troy

    Troy, Michigan, 48098

  • Natalie Warren Bryant Cancer Center at Saint Francis

    Tulsa, Oklahoma, 74136

  • Sutter Cancer Centers Radiation Oncology Services-Vacaville

    Vacaville, California, 95687

  • Sutter Solano Medical Center

    Vallejo, California, 94589

  • Sentara Virginia Beach General Hospital

    Virginia Beach, Virginia, 23454

  • MD Anderson Cancer Center at Cooper-Voorhees

    Voorhees Township, New Jersey, 08043

  • Lexington Medical Center

    West Columbia, South Carolina, 29169

  • Reading Hospital

    West Reading, Pennsylvania, 19611

  • UHHS-Westlake Medical Center

    Westlake, Ohio, 44145

  • Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

  • WellSpan Health-York Hospital

    York, Pennsylvania, 17405

Other trials in United States

Canada7 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • BCCA-Cancer Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • CHUM - Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • Ottawa Health Research Institute-General Division

    Ottawa, Ontario, K1H 1C4

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

Other trials in Canada

About this study

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

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.

Read the detailed description

OBJECTIVES:

Primary

  • 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).

Secondary

  • 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.

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

Conditions
Prostate Cancer
Being tested
GnRH agonist, Anti-androgen, TAK-700, Radiation therapy
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage IIA prostate cancer, stage IIB prostate cancer, stage III prostate cancer, stage IV prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GnRH agonistDrug

    Also called LHRH analog, leuprolide, goserelin, buserelin

    LHRH agonists are administered with a variety of techniques. The manufacturer's instructions should be followed. Begins within 6 weeks after registration (if not started prior) at same time as anti-androgen and TAK-700 (if applicable).

  • Anti-androgenDrug

    Also called flutamide, bicalutamide, androgen suppression

    Starts at same time as GnRH agonist, ends at end of radiation therapy. Either flutamide (orally 250 mg three times a day) or bicalutamide (orally 50 mg once a day).

  • TAK-700Drug

    300 mg twice daily (BID) (600 mg per day) orally, continuously for 2 years starting with ADT.

  • Radiation therapyRadiation

    Starts 8-10 weeks after initiation of ADT. Initially 45 Gy (1.8 Gy / fraction) to prostate and pelvic lymph nodes delivered with 3DCRT/IMRT, then a boost using intensity-modulated radiation therapy (IMRT), low dose rate (LDR) brachytherapy, or high dose rate (HDR) brachytherapy.

Study groups in NCT01546987
Study groupRoleWhat they receive
ADT + RTActive comparatorStandard androgen deprivation therapy (ADT) beginning two months prior to radiation therapy (RT). ADT comprised of anti-androgen continuing for two years and GnRH agonist stopping at end of RT.
Receives: Drug: GnRH agonist; Drug: Anti-androgen; Radiation: Radiation therapy
TAK-700 + ADT + RTExperimentalTAK-700 and standard androgen deprivation therapy (ADT) beginning two months prior to radiation therapy (RT). ADT comprised of anti-androgen continuing for two years and GnRH agonist stopping at end of RT. TAK-700 continues for two years.
Receives: Drug: GnRH agonist; Drug: Anti-androgen; Drug: TAK-700; Radiation: Radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Biochemical Failure (Primary Endpoint of Revised Protocol)

    Note, the revised protocol (see Limitations and Caveats) changed this outcome measure from secondary (original protocol) to primary. Biochemical failure will be defined by the Phoenix definition (PSA ≥ 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or the initiation of salvage androgen deprivation therapy. Time to failure 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, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here.

    Measured: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.

Secondary outcomes (20)

  1. Percentage of Patients Alive [Overall Survival] (Primary Endpoint of Original Protocol)

    Note, the revised protocol (see Limitations and Caveats) changed this outcome measure from primary (original protocol) to secondary. 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. 5-year rates are provided.

    Measured: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.

  2. Percentage of Participants With Grade 3 or Higher Adverse Events

    Time to grade 3 or higher adverse event (event) is defined as time from randomization to the date of first event, last known follow-up (censored), or death without failure (competing risk). Event rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here.

    Measured: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.

  3. Percentage of Participants With Local Progression

    Local recurrence (failure) is defined as biopsy proven recurrence within the prostate gland. Time to failure is defined as time from randomization to the date of failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here.

    Measured: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates reported.

  4. Percentage of Participants With Distant Metastases

    Distant metastases (failure) is defined as imaging or biopsy demonstrated evidence for systemic recurrence. Biopsy was not required, however it was encouraged in absence of a rising PSA. Time to failure 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, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here. Note, the protocol lists this endpoint as regional or distant metastasis, but regional progression data was not collected.

    Measured: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.

  5. Percentage of Participants With General Clinical Treatment Failure

    General clinical treatment failure (GCTF) is defined as: PSA > 25 ng/ml, documented local disease progression, regional or distant metastasis, or initiation of salvage androgen deprivation therapy. Failure time is defined as time from registration to the date of failure, last known follow-up (censored), or death without failure (competing risk). Failure rates are estimated using the cumulative incidence method, while treatment effect comparisons are based on cause-specific hazards (deaths censored). Five-year rates are provided here.

    Measured: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.

  6. Percentage of Participants With Death Due to Prostate Cancer

    Time to prostate cancer death is defined as time from randomization to the date of death due to prostate cancer, last known follow-up (censored), or death due to other causes (competing risk). Failure rates were to be estimated using the cumulative incidence method. If too few events occur for meaningful estimates, then only counts of events will be reported.

    Measured: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.

  7. Change in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form at One Year

    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.

    Measured: Baseline, one year

  8. Change in Patient-reported Quality of Life as Measured by Expanded Prostate Cancer Index Composite (EPIC) Short Form at One Year

    The EPIC-Short Form is a 26-item, validated self-administered tool to assess disease-specific aspects of prostate cancer and its therapies consisting of five summary domains (bowel, urinary incontinence, urinary irritation/obstruction, sexual, and hormonal function). Responses for each item form a Likert scale which are transformed to a 0-100 scale. A domain score is the average of the transformed domain item scores, ranging from 0-100 with higher scores representing better health-related quality of life (HRQOL). Change at one year is defined as one-year value - baseline value. Positive change at one year indicates improved quality of life.

    Measured: Baseline, one year

  9. Serum Testosterone

    Measured: Baseline,12 months, 24 months

  10. Fasting Total Cholesterol

    Measured: Baseline, 12 months, 24 months

  11. Serum High-density Lipoprotein (HDL)

    Measured: Baseline, 12 months, 24 months

  12. Serum High-density Lipoprotein (LDL)

    Measured: Baseline, 12 months, 24 months

  13. Hemoglobin A1c

    Measured: Baseline, 12 months, 24 months

  14. Fasting Plasma Glucose

    Measured: Baseline, 12 months, 24 months

  15. Fasting Plasma Insulin

    Measured: Baseline, 12 months, 24 months

  16. Change From Baseline in Body Mass Index (BMI)

    Body Mass Index (BMI) is a person's weight in kilograms (or pounds) divided by the square of height in meters (or feet). Change from baseline = time point value - baseline value.

    Measured: Baseline and yearly to five years.

  17. Number of Participants by Highest Grade Adverse Event

    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

    Measured: From registration to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.

  18. Testosterone Recovery at 12 and 24 Months

    Testosterone recovery is defined as testosterone level after treatment greater than 230 ng/dL. Time to testosterone recovery is defined as time from randomization to the date of testosterone recovery, biochemical, local, or distant failure (competing risk), salvage therapy (competing risk), death (competing risk), or last known follow-up (censored). Testosterone recovery rates are estimated using the cumulative incidence method.

    Measured: From registration to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years.

  19. Median Testosterone Recovery Time

    Testosterone recovery is defined as testosterone level after treatment greater than 230 ng/dL. Testosterone recovery rates are estimated using the Kaplan-Meier method, censoring for biochemical, local, or distant failure, salvage therapy, death, and otherwise alive without event. Testosterone recovery time is defined as time from randomization to testosterone recovery or censoring.

    Measured: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.

  20. Number of Patients With Clinical Survivorship Events

    Clinical survivorship events are defined as the following newly diagnosed non-fatal cardiovascular events or other clinical endpoints relevant to prostate cancer survivorship:

    type 2 diabetes, coronary artery disease, myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis, and osteoporotic fracture.

    Measured: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2012 (estimated)
  2. Study startMay 2012
  3. Primary completion1 Nov 2021
  4. Study completion4 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
239 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01546987
Sponsor's protocol ID
RTOG 1115
Other IDs
CDR0000727326, NCI-2012-00700
Status last verified
Sep 2025
First submitted
3 Mar 2012
Last updated
6 Mar 2026
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GnRH agonist, Anti-androgen and TAK-700 in people with Prostate Cancer, run by Radiation Therapy Oncology Group at 172 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 172 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Biochemical Failure (Primary Endpoint of Revised Protocol) (time frame: From randomization to last follow-up. Follow-up schedule: every 3 months from start of treatment for 2 years, then every 6 months for 3 years, then yearly. Maximum follow-up at time of analysis was 9.1 years. Five-year rates are reported here.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01546987.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.

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