Suspended
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
What is being tested
TAK-700
+ Fluorine F 18 Sodium Fluoride
+ Positron Emission Tomography
DrugRadiationProcedure
Who is being recruted
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Over 18 Years
+30 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: May 2013
Summary
Principal SponsorUniversity of Wisconsin, Madison
Last updated: December 9, 2019
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2013
Actual date on which the first participant was enrolled.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.
Principal SponsorUniversity of Wisconsin, Madison
Last updated: December 9, 2019
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
8 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Male
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesUrogenital NeoplasmsMale Urogenital DiseasesProstatic Neoplasms
Criteria
12 inclusion criteria required to participate
Adequate organ function as measured by screening laboratory values specified in the protocol
Eastern Cooperative Oncology Group performance status 0-2
Evidence of radiographic bone metastases
Has undergone orchiectomy or plan to continue receiving gonadotropin releasing hormone (GnRH) analogue therapy
Show More Criteria
18 exclusion criteria prevent from participating
Concurrent treatment with any herbal products within 7 days of study entry
Current bilateral hydronephrosis
Current bladder neck outlet obstruction
Current spinal cord compression
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalTAK-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.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Wisconsin Carbone Cancer Center
Madison, United StatesOpen University of Wisconsin Carbone Cancer Center in Google MapsSuspendedOne Study Center