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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


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

3.2 years

Safety Issue:

No

Principal Investigator

Neeraj Agarwal, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Utah

Authority:

United States: Food and Drug Administration

Study ID:

S1216

NCT ID:

NCT01809691

Start Date:

March 2013

Completion Date:

Related Keywords:

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

Name

Location

University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Washington University School of Medicine Saint Louis, Missouri  63110
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Loyola University Medical Center Maywood, Illinois  60153
CentraCare Clinic Saint Cloud, Minnesota  56303
New Mexico Cancer Care Associates Santa Fe, New Mexico  87505-7670
Nebraska Methodist Hospital Omaha, Nebraska  68114
University of Rochester Rochester, New York  14642
New Hampshire Oncology-Hematology PA Hooksett, New Hampshire  03106
Weiss Memorial Hospital Chicago,, Illinois  60640
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah  84112
University of New Mexico Albuquerque, New Mexico  87131
UC Davis Comprehensive Cancer Center Sacramento, California  95817
Decatur Memorial Hospital Decatur, Illinois  62526
University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470
Rockwood Clinic Spokane, Washington  99220
Hematology Oncology Associates Albuquerque, New Mexico  87106
John B Amos Cancer Center Columbus, Georgia  31904
Joliet Oncology-Hematology Associates Limited Joliet, Illinois  60435
Nevada Cancer Research Foundation CCOP Las Vegas, Nevada  89106
LRGHealthcare-Lakes Region General Hospital Laconia, New Hampshire  03246
Veterans Adminstration New Jersey Health Care System East Orange, New Jersey  07018-1095
Kinston Medical Specialists PA Kinston, North Carolina  28501
Dayton CCOP Dayton, Ohio  45429
Sanford Cancer Center-Oncology Clinic Sioux Falls, South Dakota  57104
University of California Medical Center At Irvine-Orange Campus Orange, California  92868
Roger Maris Cancer Center Fargo, North Dakota  58122
University of Michigan University Hospital Ann Arbor, Michigan  48109
Erlanger Medical Center Chattanooga, Tennessee  37403
Susquehanna Cancer Center Williamsport, Pennsylvania  17701
Hematology Oncology Associates of Central New York PC East Syracuse, New York  13057
Sanford Clinic North-Fargo Fargo, North Dakota  58102
Sanford Medical Center-Fargo Fargo, North Dakota  58122
Summa Akron City Hospital Akron, Ohio  44304
Southwest Oncology Group San Antonio, Texas  78245
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota  57117-5134
Sanford Clinic North-Bemidgi Bemidji, Minnesota  56601
Sanford Bismarck Medical Center Bismarck, North Dakota  58501