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RTOG 1115: 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

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. - 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.

Phase

Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.

Inclusion and Exclusion 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 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

Sites

  • California

    • Veterans Administration Long Beach Medical Center, Long Beach, California, 90822
    • Pomona Valley Hospital Medical Center, Pomona, California, 91767
    • University of California At San Diego, San Diego, California, 92103
    • Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, 95051
    • Kaiser Permanente Cancer Treatment Center, South San Francisco, California, 94080
    • UCSF-Mount Zion, San Francisco, California, 94115
    • Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park, California, 95682
    • Mercy San Juan Medical Center, Carmichael, California, 95608
    • Sutter General Hospital, Sacramento, California, 95816
    • Sutter Solano Medical Center, Vallejo, California, 94589
    • Sutter Cancer Centers Radiation Oncology Services-Vacaville, Vacaville, California, 95687
    • Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville, California, 95661
    • Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn, California, 95603
    • Rohnert Park Cancer Center, Rohnert Park, California, 94928
  • Utah

    • Dixie Medical Center Regional Cancer Center, Saint George, Utah, 84770
    • Intermountain Medical Center, Murray, Utah, 84157
    • Utah Cancer Specialists-Salt Lake City, Salt Lake City, Utah, 84106
  • Arizona

    • Arizona Oncology-Deer Valley Center, Phoenix, Arizona, 85027
    • Arizona Oncology Services Foundation, Scottsdale, Arizona, 85260
  • Oregon

    • Rogue Valley Medical Center, Medford, Oregon, 97504
  • Idaho

    • Idaho Urologic Institute PA, Meridian, Idaho, 83642
    • Saint Alphonsus Regional Medical Center, Boise, Idaho, 83706
  • Colorado

    • Poudre Valley Radiation Oncology, Fort Collins, Colorado, 80528
  • Washington

    • Saint Francis Hospital, Federal Way, Washington, 98003
    • Virginia Mason CCOP, Seattle, Washington, 98101
  • Montana

    • Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, 59405
  • Texas

    • The Klabzuba Cancer Center, Fort Worth, Texas, 76104
    • Texas Oncology PA - Bedford, Bedford, Texas, 76022
    • University of Texas Southwestern Medical Center, Dallas, Texas, 75390
    • Texas Cancer Center-Sherman, Sherman, Texas, 75090
    • Texas Oncology Cancer Center Sugar Land, Sugar Land, Texas, 77479
    • Memorial Hermann Memorial City Medical Center, Houston, Texas, 77024
    • M D Anderson Cancer Center, Houston, Texas, 77030
    • UTMB Cancer Center at Victory Lakes, League City, Texas, 77573
  • Oklahoma

    • Natalie Warren Bryant Cancer Center at Saint Francis, Tulsa, Oklahoma, 74136
  • North Dakota

    • Sanford Bismarck Medical Center, Bismarck, North Dakota, 58501
    • Sanford Medical Center-Fargo, Fargo, North Dakota, 58122
  • Nebraska

    • The Nebraska Medical Center, Omaha, Nebraska, 68198
  • Kansas

    • Kansas City Cancer Centers-Southwest, Overland Park, Kansas, 66210
  • Missouri

    • Kansas City Cancer Center - South, Kansas City, Missouri, 64131
    • Kansas City Cancer Center-Lee's Summit, Lee's Summit, Missouri, 64064
    • Mercy Hospital Springfield, Springfield, Missouri, 65804
    • Siteman Cancer Center - Saint Peters, Saint Peters, Missouri, 63376
    • Barnes-Jewish West County Hospital, Saint Louis, Missouri, 63141
    • Missouri Baptist Medical Center, Saint Louis, Missouri, 63131
    • Siteman Cancer Center-South County, Saint Louis, Missouri, 63129
    • Washington University School of Medicine, Saint Louis, Missouri, 63110
    • Southeast Cancer Center, Cape Girardeau, Missouri, 63703
  • Minnesota

    • Sanford Clinic North-Bemidgi, Bemidji, Minnesota, 56601
    • Saint Luke's Hospital of Duluth, Duluth, Minnesota, 55805
  • Wisconsin

    • Gundersen Lutheran, La Crosse, Wisconsin, 54601
    • Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, 53226
    • Appleton Medical Center, Appleton, Wisconsin, 54911
    • Columbia Saint Mary's Hospital - Ozaukee, Mequon, Wisconsin, 53097
    • Wheaton Franciscan Cancer Care - All Saints, Racine, Wisconsin, 53405
    • Columbia Saint Mary's Water Tower Medical Commons, Milwaukee, Wisconsin, 53211
    • Saint Mary's Hospital, Green Bay, Wisconsin, 54303
    • Saint Vincent Hospital, Green Bay, Wisconsin, 54301
    • Clement J. Zablocki VA Medical Center, Milwaukee, Wisconsin, 53295
    • Bay Area Medical Center, Marinette, Wisconsin, 54143
  • Illinois

    • OSF Saint Francis Medical Center, Peoria, Illinois, 61637
    • Decatur Memorial Hospital, Decatur, Illinois, 62526
    • Weiss Memorial Hospital, Chicago, Illinois, 60640
  • Louisiana

    • Ochsner Medical Center Jefferson, New Orleans, Louisiana, 70121
    • Touro Infirmary, New Orleans, Louisiana, 70115
  • Alabama

    • The Kirklin Clinic at Acton Road, Birmingham, Alabama, 35243
  • Indiana

    • Radiation Oncology Associates PC, Fort Wayne, Indiana, 46804
    • Parkview Hospital Randallia, Fort Wayne, Indiana, 46805
  • Ohio

    • University of Cincinnati, Cincinnati, Ohio, 45267
  • Kentucky

    • University of Kentucky, Lexington, Kentucky, 40536
  • Michigan

    • Northern Michigan Regional Hospital, Petoskey, Michigan, 49770
    • McLaren Cancer Institute-Owosso, Owosso, Michigan, 48867
  • Georgia

    • Piedmont Hospital, Atlanta, Georgia, 30309
    • Grady Health System, Atlanta, Georgia, 30303
    • Emory University/Winship Cancer Institute, Atlanta, Georgia, 30322
    • Atlanta VA Medical Center, Decatur, Georgia, 30033
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