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Summary

for males ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.

Official Title

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Sensitive Prostate Cancer

Keywords

Prostate Cancer TAK-700 Bicalutamide S1216 androgen therapy Phase III Prostatic Neoplasms Androgens

Eligibility

You can join if…

Open to males ages 18 years and up

  • Clinical diagnosis of metastatic prostate cancer.
  • Serum testosterone within institutional limits of normal.
  • PSA ≥ 2 ng/mL within 90 days prior to initiation of androgen deprivation. therapy (for early induction) or prior to registration (for late induction).
  • DEXA scan within 2 years prior to registration.
  • ECG within 42 days prior to registration and QTc interval ≤ 460 msec.
  • LVEF within 42 days prior to registration and within institutional limits of normal.
  • Adequate hepatic function as evidenced by bilirubin ≤ 2 x institutional upper limit of normal (ULN), SGOT (AST) and SGPT (ALT) ≤ 3 x institutional ULN, or ≤ 5 x institutional ULN if liver metastases are present.
  • Adequate renal function as evidenced by calculated creatinine clearance ≥ 40 mL/min.
  • Adequate hematologic function as evidenced by leukocytes ≥ 3,000/mcL, absolute neutrophil count (ANC) ≥ 1,500/mcL, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mcL.
  • Zubrod performance status of 0 - 2. Zubrod performance status 3 will be allowed if from bone pain only.
  • ≥ 18 years of age.
  • Men of reproduction potential and those who are surgically sterilized (i.e.,postvasectomy) must agree to practice effective barrier contraception or agree to abstain from intercourse while receiving treatment on this study and for at least 4 months after protocol treatment ends.

You CAN'T join if...

  • Known brain metastases.
  • No more than 36 months of prior neoadjuvant and/or adjuvant hormonal therapy.
  • ≥ 6 months since completion of androgen deprivation therapy.
  • Prior or concurrent therapy with ketoconazole, aminoglutethimide or abiraterone acetate, or enzalutamide (MDV3100). Concurrent megestrol for hot flashes is allowed.
  • Prior chemotherapy for treatment of metastatic prostate cancer. Prior chemotherapy in the neoadjuvant or adjuvant setting is allowed.
  • ≥ 2 years since completion of chemotherapy in the neoadjuvant or adjuvant setting.
  • Concurrent use of experimental therapy is not allowed.
  • ≥ 30 days since prior medical castration for metastatic prostate cancer.
  • If method of castration is a LHRH agonist, the patient must be willing to continue the use of LHRH and add bicalutamide or TAK-700 during protocol treatment.
  • If the patient was on an antiandrogen (e.g. bicalutamide, flutamide), the patient must be willing to switch over to bicalutamide or TAK-700 (according to randomization).
  • Prior bilateral orchiectomy.
  • Concurrent use of LHRH antagonists (e.g. Degarelix)
  • Grade III/IV cardiac disease (as defined by the NYHA Criteria), thromboembolic event,unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia.
  • Uncontrolled hypertension (defined as blood pressure > 160 mmHg systolic and > 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the Screening visit) despite appropriate medical therapy.
  • Known human immunodeficiency virus (HIV)infection, active chronic hepatitis B or C,life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study.
  • History of primary and secondary adrenal insufficiency.
  • Hypersensitivity to TAK-700, to TAK-700 metabolites, to bicalutamide, or to LHRH agonists.
  • Gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of TAK-700, including difficulty swallowing oral medications.
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.

Locations

  • UCSF Medical Center-Mount Zion
    San Francisco, California, 94115, United States
  • UCSF Medical Center-Mission Bay
    San Francisco, California, 94158, United States
  • University Oncology Associates
    Fresno, California, 93701, United States
  • California Pacific Medical Center-Pacific Campus
    San Francisco, California, 94115, United States
  • Kaiser Permanente-San Francisco
    San Francisco, California, 94115, United States
  • Kaiser Permanente
    Fresno, California, 93720, United States
  • Kaiser Permanente-South San Francisco
    South San Francisco, California, 94080, United States
  • Alta Bates Summit Medical Center-Herrick Campus
    Berkeley, California, 94704, United States
  • Kaiser Permanente-Richmond
    Richmond, California, 94801, United States
  • Mills - Peninsula Hospitals
    Burlingame, California, 94010, United States
  • Kaiser Permanente-Oakland
    Oakland, California, 94611, United States
  • Kaiser Permanente San Leandro
    San Leandro, California, 94577, United States
  • Kaiser Permanente-San Rafael
    San Rafael, California, 94903, United States
  • Kaiser Permanente-Redwood City
    Redwood City, California, 94063, United States
  • Kaiser Permanente-Walnut Creek
    Walnut Creek, California, 94596, United States
  • Sutter Cancer Research Consortium
    Novato, California, 94945, United States
  • Palo Alto Medical Foundation Health Care
    Palo Alto, California, 94301, United States
  • Kaiser Permanente-Vallejo
    Vallejo, California, 94589, United States
  • Sutter Solano Medical Center/Cancer Center
    Vallejo, California, 94589, United States
  • Kaiser Permanente-Fremont
    Fremont, California, 94538, United States
  • Palo Alto Medical Foundation-Camino Division
    Mountain View, California, 94040, United States
  • Palo Alto Medical Foundation-Gynecologic Oncology
    Mountain View, California, 94040, United States
  • Palo Alto Medical Foundation-Sunnyvale
    Sunnyvale, California, 94086, United States
  • Kaiser Permanente Medical Center - Santa Clara
    Santa Clara, California, 95051, United States
  • Kaiser Permanente-Deer Valley Medical Center
    Antioch, California, 94531, United States
  • Northbay Cancer Center
    Vacaville, California, 95687, United States
  • Kaiser Permanente Medical Center-Vacaville
    Vacaville, California, 95688, United States
  • Kaiser Permanente-Santa Teresa-San Jose
    San Jose, California, 95119, United States
  • Kaiser Permanente-Santa Rosa
    Santa Rosa, California, 95403, United States
  • Sutter Pacific Medical Foundation
    Santa Rosa, California, 95403, United States
  • Mercy UC Davis Cancer Center
    Merced, California, 95340, United States
  • Palo Alto Medical Foundation-Santa Cruz
    Santa Cruz, California, 95065, United States
  • Kaiser Permanente-Stockton
    Stockton, California, 95210, United States
  • Sutter Davis Hospital
    Davis, California, 95616, United States
  • Kaiser Permanente-South Sacramento
    Sacramento, California, 95823, United States
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California, 95817, United States
  • Sutter General Hospital
    Sacramento, California, 95816, United States
  • Kaiser Permanente-Modesto
    Modesto, California, 95356, United States
  • Kaiser Permanente - Sacramento
    Sacramento, California, 95825, United States
  • Memorial Medical Center
    Modesto, California, 95355, United States
  • Mather Veteran Affairs Medical Center
    Mather, California, 95655, United States
  • Kaiser Permanente-Roseville
    Roseville, California, 95661, United States
  • Sutter Roseville Medical Center
    Roseville, California, 95661, United States
  • AIS Cancer Center at San Joaquin Community Hospital
    Bakersfield, California, 93301, United States
  • Fremont - Rideout Cancer Center
    Marysville, California, 95901, United States
  • Sutter Auburn Faith Hospital
    Auburn, California, 95602, United States
  • PCR Oncology
    Pismo Beach, California, 93449, United States
  • Gene Upshaw Memorial Tahoe Forest Cancer Center
    Truckee, California, 96161, United States
  • Renown Regional Medical Center
    Reno, Nevada, 89502, United States
  • Keck Medical Center of USC Pasadena
    Pasadena, California, 91105, United States
  • Los Angeles County-USC Medical Center
    Los Angeles, California, 90033, United States
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California, 90033, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California, 91010, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
    Orange, California, 92868, United States
  • City of Hope Corona
    Corona, California, 92879, United States
  • Loma Linda University Medical Center
    Loma Linda, California, 92354, United States
  • Veterans Affairs Loma Linda Healthcare System
    Loma Linda, California, 92357, United States
  • USC Norris Oncology/Hematology-Newport Beach
    Newport Beach, California, 92663, United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas, Nevada, 89148, United States
  • Nevada Cancer Research Foundation CCOP
    Las Vegas, Nevada, 89106, United States
  • Comprehensive Cancer Centers of Nevada - Central Valley
    Las Vegas, Nevada, 89169, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Southwest Oncology Group
ID
NCT01809691
Phase
Phase 3
Study Type
Interventional
Last Updated
August 14, 2017