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 ADT + TAK-700 ADT + Bicalutamide

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-South San Francisco
    South San Francisco California 94080 United States
  • Kaiser Permanente
    Fresno California 93720 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

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 29, 2018