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

NCT01816048 | Terminated Phase 2 Results DMC

• 5 other identifiers: CO128102012-1107NCI-2013-01081A534260SMPH\MEDICINE\HEM-ONC
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms; Prostate Cancer

Keywords

prostate, prostate cancer

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline and 3 months

Secondary Outcomes (7)

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

  Up to 12 months

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

  Up to 14 months

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

  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.

  Approximately 24 months

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

  At baseline and 12 weeks

Study Arms (1)

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.

Drug: TAK-700; Radiation: Fluorine F 18 Sodium Fluoride; Procedure: Positron Emission Tomography; Procedure: Computed Tomography

Interventions

TAK-700 DRUG

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

Also known as: orteronel

TAK-700

Fluorine F 18 Sodium Fluoride RADIATION

Undergo NaF F18 PET/CT scan

Also known as: 18 F-NaF, F-18 NaF

TAK-700

Positron Emission Tomography PROCEDURE

Undergo 18F NaF PET/CT scan

Also known as: PET

TAK-700

Computed Tomography PROCEDURE

Undergo 18F NaF PET/CT scan

Also known as: CT, CAT Scan

TAK-700

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

orteronel; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Dr. Justine Bruce
• Organization: University of Wisconsin Carbone Cancer Center

jybruce@medicine.wisc.edu

608-262-4961

Study Officials

• Justine Y Bruce, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 21, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: November 1, 2016
• Last Updated: December 9, 2019
• Results First Posted: July 19, 2017

Record last verified: 2017-12

Locations

US (1)