Clinical trial NCT01816048: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Prostate Cancer
Keywords: prostate, prostate cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2013-03-21
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With a Change in Maximum NaF PET/CT Standardized Uptake Values
timeFrame: Baseline and 3 months
measure: Number of Participants With Change in Prostate Specific Antigen (PSA) Response Rate
timeFrame: Baseline and 3 months
measure: Number of Participants With a Change in Total NaF PET/CT Standardized Uptake Values
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Number of Subjects Who Experience Adverse Events While on Treatment With TAK 700
timeFrame: Up to 12 months
measure: Number of Patients With a Measurable Change in PSA Kinetics With TAK700 From Baseline to Off Treatment
timeFrame: Up to 14 months
measure: Number of Participants With Changes in NaF PET/CT Results in Response to TAK700
timeFrame: At baseline and 12 weeks
measure: 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.
timeFrame: Approximately 24 months
measure: Number of Participants With a Change in the Number of Circulating Tumor Cells Using One or More Methods (Epispot)
timeFrame: At baseline and 12 weeks
measure: 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
timeFrame: At baseline, one month, three months
measure: PSA Response Rate and Circulating Tumor Cell Counts of Subjects Receiving TAK700 to NaF PET/CT Imaging Results
timeFrame: Baseline, one month, 2 months, 3 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Justine Y Bruce, MD
role: PRINCIPAL_INVESTIGATOR
References: