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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

Primary Purpose

Prostatic Neoplasms, Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TAK-700
Fluorine F 18 Sodium Fluoride
Positron Emission Tomography
Computed Tomography
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring prostate, prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin Carbone Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TAK-700

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants With a Change in Maximum NaF PET/CT Standardized Uptake Values
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.
Number of Participants With Change in Prostate Specific Antigen (PSA) Response Rate
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 Total NaF PET/CT Standardized Uptake Values
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.

Secondary Outcome Measures

Number of Subjects Who Experience Adverse Events While on Treatment With TAK 700
The number of subjects experiencing adverse events per CTCAE 4.0 while on treatment.
Number of Patients With a Measurable Change in PSA Kinetics With TAK700 From Baseline to Off Treatment
Stable: no change in PSA kinetics Decrease: less than baseline Increase: greater than baseline PSA data was gathered at baseline and off treatment.
Number of Participants With Changes in NaF PET/CT Results in Response to TAK700
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.
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.
Number of Participants With a Change in the Number of Circulating Tumor Cells Using One or More Methods (Epispot)
Baseline compared to 12 weeks. Value at three months minus value at baseline.
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
Change from baseline to one month and three month.
PSA Response Rate and Circulating Tumor Cell Counts of Subjects Receiving TAK700 to NaF PET/CT Imaging Results

Full Information

First Posted
March 19, 2013
Last Updated
November 19, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01816048
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Study supporter (Takeda) ended study drug for prostate cancer; enrollment ended prematurely.
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Millennium Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Prostate Cancer
Keywords
prostate, prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAK-700
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TAK-700
Other Intervention Name(s)
orteronel
Intervention Description
TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles
Intervention Type
Radiation
Intervention Name(s)
Fluorine F 18 Sodium Fluoride
Other Intervention Name(s)
18 F-NaF, F-18 NaF
Intervention Description
Undergo NaF F18 PET/CT scan
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
PET
Intervention Description
Undergo 18F NaF PET/CT scan
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CT, CAT Scan
Intervention Description
Undergo 18F NaF PET/CT scan
Primary Outcome Measure Information:
Title
Number of Participants With a Change in Maximum NaF PET/CT Standardized Uptake Values
Description
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.
Time Frame
Baseline and 3 months
Title
Number of Participants With Change in Prostate Specific Antigen (PSA) Response Rate
Description
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.
Time Frame
Baseline and 3 months
Title
Number of Participants With a Change in Total NaF PET/CT Standardized Uptake Values
Description
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.
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Number of Subjects Who Experience Adverse Events While on Treatment With TAK 700
Description
The number of subjects experiencing adverse events per CTCAE 4.0 while on treatment.
Time Frame
Up to 12 months
Title
Number of Patients With a Measurable Change in PSA Kinetics With TAK700 From Baseline to Off Treatment
Description
Stable: no change in PSA kinetics Decrease: less than baseline Increase: greater than baseline PSA data was gathered at baseline and off treatment.
Time Frame
Up to 14 months
Title
Number of Participants With Changes in NaF PET/CT Results in Response to TAK700
Description
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.
Time Frame
At baseline and 12 weeks
Title
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
Title
Number of Participants With a Change in the Number of Circulating Tumor Cells Using One or More Methods (Epispot)
Description
Baseline compared to 12 weeks. Value at three months minus value at baseline.
Time Frame
At baseline and 12 weeks
Title
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
Description
Change from baseline to one month and three month.
Time Frame
At baseline, one month, three months
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justine Y Bruce, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Links:
URL
https://cancer.wisc.edu/
Description
University of Wisconsin Carbone Cancer Center

Learn more about this trial

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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