Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Neoplasm Metastasis

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Anti-Infective Agents

Fluorides

Listerine

Sodium Fluoride

Protective Agents

Anti-Infective Agents, Local

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 will be administered at 300mg twice per day on 28-day continuous cycles

TAK-700

Fluorine F 18 Sodium Fluoride

Positron Emission Tomography

Computed Tomography

Justine Y Bruce, MD

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.

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

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

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.

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.

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.

The number of subjects experiencing adverse events per CTCAE 4.0 while on treatment.

Stable: no change in PSA kinetics Decrease: less than baseline Increase: greater than baseline

PSA data was gathered at baseline and off treatment.

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.

Baseline compared to 12 weeks. Value at three months minus value at baseline.

Change from baseline to one month and three month.

Millennium Pharmaceuticals, Inc.

University of Wisconsin, Madison

All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.

TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.

TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles

Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan

Positron Emission Tomography: Undergo 18F NaF PET/CT scan

Computed Tomography: Undergo 18F NaF PET/CT scan

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Justine Bruce

The study closed early so only 8 of 20 planned were enrolled and of the 8, only 4 completed the week 12 scan.

Number of Participants With a Change in Maximum NaF PET/CT Standardized Uptake Values

Study closed early and only 8 of planned 20 enrolled. Four subjects came off study prior to the three month time point.

Number of Participants With Change in Prostate Specific Antigen (PSA) Response Rate

TAK-700 will be administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.

TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles

Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan at screen, week 4-8 and week 12

Number of Subjects Who Experience Adverse Events While on Treatment With TAK 700

Due to study closing early only 8 of planned 20 patients enrolled.

Number of Patients With a Measurable Change in PSA Kinetics With TAK700 From Baseline to Off Treatment

Due to study closing early only 8 of planned 20 patients enrolled and only 4 of the 8 subjects enrolled completed the week 12 scan.

Number of Participants With Changes in NaF PET/CT Results in Response to TAK700

Due to study closing early, only 8 of planned 20 patients enrolled. Data for this endpoint was not obtained.

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.

Due to study closing early only 8 of 12 patients enrolled, and only 5 subjects obtained a week 12 CTC test.

Number of Participants With a Change in the Number of Circulating Tumor Cells Using One or More Methods (Epispot)

Cycle 1 (one month)

Cycle 4 (three months)

Due to study closing early only 8 of planned 20 enrolled. All subjects completed one month of treatment; only 4 subjects completed the week 12 scan.

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

Data was not collected for this outcome measure.

Spots Global Cancer Trial Database for 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

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