NaF Positron Emission Tomography/Computed Tomography (PET/CT)Imaging to Assess Treatment Responsiveness to TAK-700 in Patients With Castrate Resistant Prostate Cancer (CRPC) With Bone Metastasis

University of Wisconsin (UW)

Status and phase: Terminated; Phase 2

Conditions: Prostatic Neoplasms; Prostate Cancer

Treatments: Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Radiation: Fluorine F 18 Sodium Fluoride; Drug: TAK-700

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01816048

CO12810

A534260 (Other Identifier)

NCI-2013-01081 (Registry Identifier)

SMPH\MEDICINE\HEM-ONC (Other Identifier)

2012-1107 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess whether NaF PET/CT scans can be used to evaluate treatment response in bone metastases in subjects with prostate cancer treated with the investigational drug, TAK-700.

Enrollment: 8 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 protocol
• 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 imaging
• 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 registration
• history of allergic reactions attributed to compounds similar to sodium fluoride F-18 (NaF)
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

TAK-700

Experimental group

Description:

TAK-700 will be administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles. The most common way of assessing bone metastasis is planar bone scintigraphy or single photon emission computed tomography (SPECT), though both lack high spatial resolution and thus make small metastases detection inaccurate. Positron emission tomography (PET) is a successful imaging modality with a higher resolution than SPECT, but has not been widely adopted in bone imaging. One of the most promising PET imaging agents for detection of bone metastasis is 18F-Sodium Fluoride (Fluorine F 18 Sodium Fluoride, or NaF). NaF uptake is characterized by high and rapid bone uptake accompanied by very rapid blood clearance, which results in a high bone-to-background ration in a short time.

Treatment:

Drug: TAK-700

Radiation: Fluorine F 18 Sodium Fluoride

Procedure: Computed Tomography

Procedure: Positron Emission Tomography