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A Pharmacodynamic Study Using NaF PET/CT Imaging to Assess Treatment Responsiveness to TAK-700 in Patients With Metastatic Castrate Resistant Prostate Cancer to Bone

Phase 2
18 Years
Open (Enrolling)
Prostatic Neoplasms, Prostate Cancer

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Trial Information

A Pharmacodynamic Study Using NaF PET/CT Imaging to Assess Treatment Responsiveness to TAK-700 in Patients With Metastatic Castrate Resistant Prostate Cancer to Bone

Inclusion Criteria:

- Male patients 18 years or older

- Voluntary written consent

- Histologically proven adenocarcinoma of the prostate

- Evidence of radiographic bone metastases

- May have received prior chemotherapy for metastatic disease, but prior chemotherapy
is not a requirement for eligibility

- Eastern Cooperative Oncology Group performance status 0-2

- Serum testosterone level is less than or equal to 50 ng/dL

- Has undergone orchiectomy or plan to continue receiving gonadotropin releasing
hormone (GnRH) analogue therapy

- Adequate organ function as measured by screening laboratory values specified in the

- Must agree to use appropriate contraceptives prior to study procedures, during
duration of study participation and for 4 months after last dose of TAK 700

- Must be able to lie flat for greater than or equal to 30 minutes during PET/CT

- Screening calculated ejection fraction of greater than or equal to 50% by multigated
radionuclide angiography (MUGA) scan or Echocardiogram

Exclusion Criteria:

- Received Strontium-89, Samarium-153, or other radioisotope within 3 months of

- history of allergic reactions attributed to compounds similar to sodium fluoride F-18

- history of seizure disorder

- Known history of brain metastases

- Concurrent treatment with any herbal products within 7 days of study entry

- Received radiotherapy less than or equal to 4 weeks prior to registration

- Known hypersensitivity to TAK-700 or related compounds

- Prior therapy for treatment of metastatic castrate resistant prostate cancer with any
androgen biosynthesis inhibitor or androgen signaling pathway inhibitor such as:
enzalutamide (MDV-3100), abiraterone, ketoconazole, or aminoglutethimide

- Current bladder neck outlet obstruction

- Current spinal cord compression

- Current bilateral hydronephrosis

- History of adrenal insufficiency

- History of myocardial infarction, unstable symptomatic ischemic heart disease,
ongoing arrhythmias (over grade 2), thromboembolic events, or any other cardiac
condition within 6 months prior to first dose of study drug.

- Uncontrolled high blood pressure

- Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or
hepatitis C

- Major surgery less than or equal to 4 weeks before the first dose of study drug

- Serious infection less than or equal to 2 weeks before the first dose of study drug

- Known gastrointestinal (GI) disease or GI procedure that could interfere with oral
absorption or tolerance of TAK-700, including difficulty swallowing capsules

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To measure changes in NaF PET/CT standardized uptake values (SUVmean and SUV max) from prior to dosing with Tak-700 to 4-8 weeks after starting treatment with TAK-700

Outcome Time Frame:

baseline and 8 weeks

Safety Issue:


Principal Investigator

Justine Y Bruce, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison


United States: Food and Drug Administration

Study ID:




Start Date:

May 2013

Completion Date:

May 2016

Related Keywords:

  • Prostatic Neoplasms
  • Prostate Cancer
  • prostate, prostate cancer
  • Neoplasms
  • Prostatic Neoplasms



University of Wisconsin Carbone Cancer CenterMadison, Wisconsin  53792-5669