Overview

This trial is active, not recruiting.

Conditions prostatic neoplasms, prostate cancer
Treatments tak-700, fluorine f 18 sodium fluoride, positron emission tomography, computed tomography
Phase phase 2
Sponsor University of Wisconsin, Madison
Collaborator Millennium Pharmaceuticals, Inc.
Start date May 2013
End date December 2015
Trial size 8 participants
Trial identifier NCT01816048, CO12810

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 orteronel
TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles
fluorine f 18 sodium fluoride 18 F-NaF
Undergo NaF F18 PET/CT scan
positron emission tomography PET
Undergo 18F NaF PET/CT scan
computed tomography CT
Undergo 18F NaF PET/CT scan

Primary Outcomes

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
time frame: baseline to month 3
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)
time frame: baseline to month 3

Secondary Outcomes

Measure
Number of subjects who experience adverse events while on treatment with TAK 700
time frame: Approximately 12 months
Measure change in PSA kinetics with TAK700 from baseline to off treatment
time frame: baseline and off treatment
Measure changes in NaF PET/CT results in response to TAK700
time frame: baseline and 8 weeks
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.
time frame: Approximately 24 months
To document the change in the number of circulating tumor cells using one or more methods -includes PSA Elispot, flow cytometry and the VeriFAST platform
time frame: baseline, one month, 3 months and at off study visit
To document 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.
time frame: baseline, one month and 3 months
To compare PSA response rate and circulating tumor cell counts of subjects receiving TAK700 to NaF PET/CT imaging results
time frame: Baseline, one month, 2 months, 3 months

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title 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
Principal investigator Justine Y Bruce, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.