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

Phase 2

Terminated

Conditions: Prostate Cancer
Prostatic Neoplasms

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

Registration Number: NCT01816048

Lead Sponsor: University of Wisconsin, Madison

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: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: Male

Target Recruitment: 8

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAK-700	Fluorine F 18 Sodium Fluoride	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.
TAK-700	Positron Emission Tomography	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.
TAK-700	Computed Tomography	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.
TAK-700	TAK-700	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Change in Total NaF PET/CT Standardized Uptake Values	Baseline and 3 months	To measure changes in NaF PET/CT standardized uptake values (SUV total) from prior to dosing with Tak-700 to12 weeks after starting treatment with TAK-700. Percent change from three months to baseline; value at three months minus value at baseline.
Number of Participants With Change in Prostate Specific Antigen (PSA) Response Rate	Baseline and 3 months	Measure prostate specific antigen (PSA) response rate in patients treated with TAK700, as measured by a decline in the PSA level from baseline to the month 3 assessment according to the Prostate Cancer Clinical Trials Working Group (PCWG2), at least a 50% decrease from baseline. Percent increase or decrease from month three compared to baseline.
Number of Participants With a Change in Maximum NaF PET/CT Standardized Uptake Values	Baseline and 3 months	To measure changes in NaF PET/CT standardized uptake values (SUVmax) from prior to dosing with Tak-700 to12 weeks after starting treatment with TAK-700. Value at three months minus value at baseline.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With a Change in the Number of Circulating Tumor Cells Using One or More Methods (Epispot)	At baseline and 12 weeks	Baseline compared to 12 weeks. Value at three months minus value at baseline.
Number of Subjects Who Experience Adverse Events While on Treatment With TAK 700	Up to 12 months	The number of subjects experiencing adverse events per CTCAE 4.0 while on treatment.
Number of Participants With Changes in NaF PET/CT Results in Response to TAK700	At baseline and 12 weeks	This is an exploratory endpoint as we are planning to identify other new parameters during the PET/CT scanning that may be more predictive of response (such as SUV volume, or dynamic changes during the scanning period). Changes in results at week 12 compared to baseline. Value at 12 weeks minus value at baseline.
PSA Response Rate and Circulating Tumor Cell Counts of Subjects Receiving TAK700 to NaF PET/CT Imaging Results	Baseline, one month, 2 months, 3 months
Number of Patients With a Measurable Change in PSA Kinetics With TAK700 From Baseline to Off Treatment	Up to 14 months	Stable: no change in PSA kinetics Decrease: less than baseline Increase: greater than baseline PSA data was gathered at baseline and off treatment.
Compare Changes on NaF PET/CT After Treatment With TAK700 With Standard Clinical Outcomes Including PSA Doubling Time, Response Evaluation Criteria in Solid Tumors (RECIST), and Radiographic Progression Free Survival.	Approximately 24 months
Number of Participants With Change in the Number of Circulating Tumor Cells Using the Cell Search System (Veridex, LLC) Obtained Prior to Beginning Treatment With TAK 700, After Completing One Cycle and After Completing 3 Cycles	At baseline, one month, three months	Change from baseline to one month and three month.