Prostatic NeoplasmsPhase 2NCT01816048

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 Phase 2 study testing TAK-700, Fluorine F 18 Sodium Fluoride and Positron Emission Tomography in people with Prostatic Neoplasms and Prostate Cancer, run by University of Wisconsin, Madison at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostatic Neoplasms, Prostate Cancer
What is being tested?: TAK-700, Fluorine F 18 Sodium Fluoride and Positron Emission Tomography
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: May 2013to Nov 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 12Show fewer

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

Who cannot join

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

Show all 18Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792

Other trials in United States

About this study

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

Conditions: Prostatic Neoplasms, Prostate Cancer
Being tested: TAK-700, Fluorine F 18 Sodium Fluoride, Positron Emission Tomography, Computed Tomography
Keywords: prostate, prostate cancer
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAK-700Drug
Also called orteronel
TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles
Fluorine F 18 Sodium FluorideRadiation
Also called 18 F-NaF, F-18 NaF
Undergo NaF F18 PET/CT scan
Positron Emission TomographyProcedure or surgery
Also called PET
Undergo 18F NaF PET/CT scan
Computed TomographyProcedure or surgery
Also called CT, CAT Scan
Undergo 18F NaF PET/CT scan

Study groups in NCT01816048
Study group	Role	What they receive
TAK-700	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. Receives: Drug: TAK-700; Radiation: Fluorine F 18 Sodium Fluoride; Procedure: Positron Emission Tomography; Procedure: Computed Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months

Secondary outcomes (7)

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.
Measured: Up to 12 months
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.
Measured: Up to 14 months
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.
Measured: At baseline and 12 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.
Measured: Approximately 24 months
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.
Measured: At baseline and 12 weeks
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.
Measured: At baseline, one month, three months
PSA Response Rate and Circulating Tumor Cell Counts of Subjects Receiving TAK700 to NaF PET/CT Imaging Results
Measured: Baseline, one month, 2 months, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Nov 2016

First posted21 Mar 2013 (estimated)
Study startMay 2013
Primary completionDec 2015
Study completionNov 2016

Why it stopped: Study supporter (Takeda) ended study drug for prostate cancer; enrollment ended prematurely.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01816048
Sponsor's protocol ID: CO12810
Other IDs: 2012-1107, NCI-2013-01081, A534260, SMPH\MEDICINE\HEM-ONC
Status last verified: Dec 2017
First submitted: 19 Mar 2013
Last updated: 9 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01816048
Acronym / sponsor ID: CO12810
Conditions: Prostatic Neoplasms, Prostate Cancer
Keywords: prostate, prostate cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study supporter (Takeda) ended study drug for prostate cancer; enrollment ended prematurely.
Enrolment: 8 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Collaborators: Millennium Pharmaceuticals, Inc.
Study start: May 2013
Primary completion: Dec 2015 (actual)
Study completion: Nov 2016 (actual)
First posted: 21 Mar 2013 (estimated)
Results: Posted 19 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TAK-700	Experimental	Drug: TAK-700, Radiation: Fluorine F 18 Sodium Fluoride, Procedure: Positron Emission Tomography, Procedure: Computed TomographyTAK-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.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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

Key exclusion criteria (18 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAK-700Also: orteronelTAK-700 will be administered at 300mg twice per day on 28-day continuous cycles	Drug	TAK-700
Fluorine F 18 Sodium FluorideAlso: 18 F-NaF, F-18 NaFUndergo NaF F18 PET/CT scan	Radiation	TAK-700
Positron Emission TomographyAlso: PETUndergo 18F NaF PET/CT scan	Procedure or surgery	TAK-700
Computed TomographyAlso: CT, CAT ScanUndergo 18F NaF PET/CT scan	Procedure or surgery	TAK-700

Primary outcome

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

7 secondary outcomes

Number of Subjects Who Experience Adverse Events While on Treatment With TAK 700
Time frame: Up to 12 months
Number of Patients With a Measurable Change in PSA Kinetics With TAK700 From Baseline to Off Treatment
Time frame: Up to 14 months
Number of Participants With Changes in NaF PET/CT Results in Response to TAK700
Time frame: At baseline and 12 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
Number of Participants With a Change in the Number of Circulating Tumor Cells Using One or More Methods (Epispot)
Time frame: At baseline and 12 weeks
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
Time frame: At baseline, one month, three months
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

Results and safety

Results posted to the registry on 19 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TAK-700	8	2

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

Time frame: Baseline and 3 months. Count of participants. Unit: Participants

Measure	TAK-700 n = 4
SUVmax decrease	3
SUVmax increase	1

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

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

Time frame: Baseline and 3 months. Count of participants. Unit: Participants

Measure	TAK-700 n = 4
PSA decline >= 50%	3
PSA decline =< 50%	1

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

Primary outcome: Number of Participants With a Change in Total NaF PET/CT Standardized Uptake Values

Time frame: Baseline and 3 months. Count of participants. Unit: Participants

Measure	TAK-700 n = 4
SUV total increase	1
SUV total decrease	2
SUV total no change	1

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

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year, 11 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAK-700	4 of 8 (50%)	8 of 8 (100%)	1 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Justine Y Bruce, MD principal investigator

University of Wisconsin, Madison

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a Change in Maximum NaF PET/CT Standardized Uptake Values (time frame: Baseline and 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01816048.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.