Conditions: Prostatic Neoplasms Prostate Cancer
Keywords: prostate, prostate cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 8
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: 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.

Interventions: intervention 1: TAK-700 intervention 2: Fluorine F 18 Sodium Fluoride intervention 3: Positron Emission Tomography intervention 4: Computed Tomography
Intervention descriptions: intervention 1: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles intervention 2: Undergo NaF F18 PET/CT scan intervention 3: Undergo 18F NaF PET/CT scan intervention 4: Undergo 18F NaF PET/CT scan

Protocol document: