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Eligibility
for males ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator
Terence W. Friedlander

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 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

  • University Oncology Associates accepting new patients
    Fresno, California, 93701, United States
  • California Pacific Medical Center-Pacific Campus accepting new patients
    San Francisco, California, 94115, United States
  • Kaiser Permanente-San Francisco accepting new patients
    San Francisco, California, 94115, United States
  • Kaiser Permanente accepting new patients
    Fresno, California, 93720, United States
  • Kaiser Permanente-South San Francisco accepting new patients
    South San Francisco, California, 94080, United States
  • Alta Bates Summit Medical Center-Herrick Campus accepting new patients
    Berkeley, California, 94704, United States
  • Kaiser Permanente-Richmond accepting new patients
    Richmond, California, 94801, United States
  • Mills - Peninsula Hospitals accepting new patients
    Burlingame, California, 94010, United States
  • Kaiser Permanente-Oakland accepting new patients
    Oakland, California, 94611, United States
  • Kaiser Permanente San Leandro accepting new patients
    San Leandro, California, 94577, United States
  • Kaiser Permanente-San Rafael accepting new patients
    San Rafael, California, 94903, United States
  • Kaiser Permanente-Redwood City accepting new patients
    Redwood City, California, 94063, United States
  • Kaiser Permanente-Walnut Creek accepting new patients
    Walnut Creek, California, 94596, United States
  • Sutter Cancer Research Consortium accepting new patients
    Novato, California, 94945, United States
  • Palo Alto Medical Foundation Health Care accepting new patients
    Palo Alto, California, 94301, United States
  • Kaiser Permanente-Vallejo accepting new patients
    Vallejo, California, 94589, United States
  • Sutter Solano Medical Center/Cancer Center accepting new patients
    Vallejo, California, 94589, United States
  • Kaiser Permanente-Fremont accepting new patients
    Fremont, California, 94538, United States
  • Palo Alto Medical Foundation-Camino Division accepting new patients
    Mountain View, California, 94040, United States
  • Palo Alto Medical Foundation-Gynecologic Oncology accepting new patients
    Mountain View, California, 94040, United States
  • Palo Alto Medical Foundation-Sunnyvale accepting new patients
    Sunnyvale, California, 94086, United States
  • Kaiser Permanente Medical Center - Santa Clara accepting new patients
    Santa Clara, California, 95051, United States
  • Kaiser Permanente-Deer Valley Medical Center accepting new patients
    Antioch, California, 94531, United States
  • Northbay Cancer Center currently not accepting new patients, but might later
    Vacaville, California, 95687, United States
  • Kaiser Permanente Medical Center-Vacaville accepting new patients
    Vacaville, California, 95688, United States
  • Saint Helena Hospital withdrawn
    Saint Helena, California, 94574, United States
  • Kaiser Permanente-Santa Teresa-San Jose accepting new patients
    San Jose, California, 95119, United States
  • Kaiser Permanente-Santa Rosa accepting new patients
    Santa Rosa, California, 95403, United States
  • Sutter Pacific Medical Foundation accepting new patients
    Santa Rosa, California, 95403, United States
  • Mercy UC Davis Cancer Center accepting new patients
    Merced, California, 95340, United States
  • Palo Alto Medical Foundation-Santa Cruz accepting new patients
    Santa Cruz, California, 95065, United States
  • Kaiser Permanente-Stockton accepting new patients
    Stockton, California, 95210, United States
  • Sutter Davis Hospital accepting new patients
    Davis, California, 95616, United States
  • Kaiser Permanente-South Sacramento accepting new patients
    Sacramento, California, 95823, United States
  • University of California Davis Comprehensive Cancer Center accepting new patients
    Sacramento, California, 95817, United States
  • Sutter General Hospital accepting new patients
    Sacramento, California, 95816, United States
  • Kaiser Permanente-Modesto accepting new patients
    Modesto, California, 95356, United States
  • Kaiser Permanente - Sacramento accepting new patients
    Sacramento, California, 95825, United States
  • Memorial Medical Center accepting new patients
    Modesto, California, 95355, United States
  • Mather Veteran Affairs Medical Center currently not accepting new patients, but might later
    Mather, California, 95655, United States
  • Kaiser Permanente-Roseville accepting new patients
    Roseville, California, 95661, United States
  • Sutter Roseville Medical Center accepting new patients
    Roseville, California, 95661, United States
  • AIS Cancer Center at San Joaquin Community Hospital accepting new patients
    Bakersfield, California, 93301, United States
  • Fremont - Rideout Cancer Center accepting new patients
    Marysville, California, 95901, United States
  • Sutter Auburn Faith Hospital accepting new patients
    Auburn, California, 95602, United States
  • PCR Oncology accepting new patients
    Pismo Beach, California, 93449, United States
  • Feather River Cancer Center withdrawn
    Paradise, California, 95969, United States
  • Gene Upshaw Memorial Tahoe Forest Cancer Center accepting new patients
    Truckee, California, 96161, United States
  • Renown Regional Medical Center accepting new patients
    Reno, Nevada, 89502, United States
  • Keck Medical Center of USC Pasadena accepting new patients
    Pasadena, California, 91105, United States
  • Los Angeles County-USC Medical Center accepting new patients
    Los Angeles, California, 90033, United States
  • USC / Norris Comprehensive Cancer Center accepting new patients
    Los Angeles, California, 90033, United States
  • City of Hope Comprehensive Cancer Center accepting new patients
    Duarte, California, 91010, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center accepting new patients
    Orange, California, 92868, United States
  • City of Hope Corona accepting new patients
    Corona, California, 92879, United States
  • Loma Linda University Medical Center accepting new patients
    Loma Linda, California, 92354, United States
  • Veterans Affairs Loma Linda Healthcare System accepting new patients
    Loma Linda, California, 92357, United States
  • USC Norris Oncology/Hematology-Newport Beach accepting new patients
    Newport Beach, California, 92663, United States
  • Comprehensive Cancer Centers of Nevada accepting new patients
    Las Vegas, Nevada, 89148, United States
  • Nevada Cancer Research Foundation CCOP accepting new patients
    Las Vegas, Nevada, 89106, United States
  • Comprehensive Cancer Centers of Nevada - Central Valley accepting new patients
    Las Vegas, Nevada, 89169, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Southwest Oncology Group
ID
NCT01809691
Phase
Phase 3
Lead Scientist
Terence W. Friedlander
Study Type
Interventional
Last Updated
May 1, 2017
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