Prostatic Neoplasms, Prostate Cancer
Conditions
Keywords
prostate, prostate cancer
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.
Interventions
PROCEDUREComputed Tomography
Undergo 18F NaF PET/CT scan
DRUGTAK-700
TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles
RADIATIONFluorine F 18 Sodium Fluoride
Undergo NaF F18 PET/CT scan
PROCEDUREPositron Emission Tomography
Undergo 18F NaF PET/CT scan
Sponsors
Millennium Pharmaceuticals, Inc.
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Change in Maximum NaF PET/CT Standardized Uptake Values | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline compared to 12 weeks. Value at three months minus value at baseline. |
| Number of Subjects Who Experience Adverse Events While on Treatment With TAK 700 | Up to 12 months | The number of subjects experiencing adverse events per CTCAE 4.0 while on treatment. |
| PSA Response Rate and Circulating Tumor Cell Counts of Subjects Receiving TAK700 to NaF PET/CT Imaging Results | Baseline, one month, 2 months, 3 months | — |
| 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 | At baseline, one month, three months | Change from baseline to one month and three month. |
| Number of Patients With a Measurable Change in PSA Kinetics With TAK700 From Baseline to Off Treatment | Up to 14 months | 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 | At baseline and 12 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TAK-700 TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles.
TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles
Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan
Positron Emission Tomography: Undergo 18F NaF PET/CT scan
Computed Tomography: Undergo 18F NaF PET/CT scan | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 1 |
| Overall Study | Disease Progression | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | TAK-700 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 8 |
| other Total, other adverse events | 8 / 8 |
| serious Total, serious adverse events | 4 / 8 |
Outcome results
Primary
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.
Time frame: Baseline and 3 months
Population: The study closed early so only 8 of 20 planned were enrolled and of the 8, only 4 completed the week 12 scan.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAK-700 | Number of Participants With a Change in Maximum NaF PET/CT Standardized Uptake Values | SUVmax decrease | 3 Participants |
| TAK-700 | Number of Participants With a Change in Maximum NaF PET/CT Standardized Uptake Values | SUVmax increase | 1 Participants |
Primary
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.
Time frame: Baseline and 3 months
Population: The study closed early so only 8 of 20 planned were enrolled and of the 8, only 4 completed the week 12 scan.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAK-700 | Number of Participants With a Change in Total NaF PET/CT Standardized Uptake Values | SUV total increase | 1 Participants |
| TAK-700 | Number of Participants With a Change in Total NaF PET/CT Standardized Uptake Values | SUV total decrease | 2 Participants |
| TAK-700 | Number of Participants With a Change in Total NaF PET/CT Standardized Uptake Values | SUV total no change | 1 Participants |
Primary
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.
Time frame: Baseline and 3 months
Population: Study closed early and only 8 of planned 20 enrolled. Four subjects came off study prior to the three month time point.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAK-700 | Number of Participants With Change in Prostate Specific Antigen (PSA) Response Rate | PSA decline >= 50% | 3 Participants |
| TAK-700 | Number of Participants With Change in Prostate Specific Antigen (PSA) Response Rate | PSA decline =< 50% | 1 Participants |
Secondary
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
Population: Due to study closing early, only 8 of planned 20 patients enrolled. Data for this endpoint was not obtained.
Secondary
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.
Time frame: At baseline and 12 weeks
Population: Due to study closing early only 8 of 12 patients enrolled, and only 5 subjects obtained a week 12 CTC test.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAK-700 | Number of Participants With a Change in the Number of Circulating Tumor Cells Using One or More Methods (Epispot) | Increase in circulating tumors | 2 Participants |
| TAK-700 | Number of Participants With a Change in the Number of Circulating Tumor Cells Using One or More Methods (Epispot) | Decrease in circulating tumors | 3 Participants |
Secondary
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.
Time frame: At baseline, one month, three months
Population: Due to study closing early only 8 of planned 20 enrolled. All subjects completed one month of treatment; only 4 subjects completed the week 12 scan.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| TAK-700 | 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 | Cycle 1 (one month) | Increase in circulating tumors | 2 Participants |
| TAK-700 | 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 | Cycle 1 (one month) | Decrease in circulating tumors | 5 Participants |
| TAK-700 | 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 | Cycle 1 (one month) | No change | 1 Participants |
| TAK-700 | 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 | Cycle 4 (three months) | Increase in circulating tumors | 1 Participants |
| TAK-700 | 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 | Cycle 4 (three months) | Decrease in circulating tumors | 1 Participants |
| TAK-700 | 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 | Cycle 4 (three months) | No change | 2 Participants |
Secondary
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.
Time frame: At baseline and 12 weeks
Population: Due to study closing early only 8 of planned 20 patients enrolled and only 4 of the 8 subjects enrolled completed the week 12 scan.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAK-700 | Number of Participants With Changes in NaF PET/CT Results in Response to TAK700 | Increase in SUV total | 1 Participants |
| TAK-700 | Number of Participants With Changes in NaF PET/CT Results in Response to TAK700 | No change | 1 Participants |
| TAK-700 | Number of Participants With Changes in NaF PET/CT Results in Response to TAK700 | Decrease in SUV total | 2 Participants |
Secondary
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.
Time frame: Up to 14 months
Population: Due to study closing early only 8 of planned 20 patients enrolled.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAK-700 | Number of Patients With a Measurable Change in PSA Kinetics With TAK700 From Baseline to Off Treatment | Stable | 1 Participants |
| TAK-700 | Number of Patients With a Measurable Change in PSA Kinetics With TAK700 From Baseline to Off Treatment | Decrease in PSA | 3 Participants |
| TAK-700 | Number of Patients With a Measurable Change in PSA Kinetics With TAK700 From Baseline to Off Treatment | Increase in PSA | 4 Participants |
Secondary
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.
Time frame: Up to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-700 | Number of Subjects Who Experience Adverse Events While on Treatment With TAK 700 | 8 participants |
Secondary
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
Population: Data was not collected for this outcome measure.