Prostate Cancer
Conditions
Keywords
89Zr-DFO-MSTP2109A, tracer, pet scan, 12-178
Brief summary
The purpose of this study is to see if a new diagnostic research agent named 89Zr-DFO-MSTP2109A can show prostate cancer tumors on a PET scan; as well as see how long 89Zr-DFO-MSTP2109A lasts in the blood when given in small amounts. DFO-MSTP2109A is an antibody that works against STEAP1 - found on the surface of prostate cancer cells. Attached to the DFO-MSTP2109A is a radioactive material called 89ZR, which allows it to be imaged by a PET scanner. The results of this study may help researchers know whether 89Zr-DFO-MSTP2109A can be used as a diagnostic agent for finding prostate cancer that have STEAP1 on its surface with a PET scanner. The reason why identifying STEAP1 on prostate cancer cells is that new therapies are being developed to target STEAP1 prostate cancer cells.
Interventions
DRUG89Zr- DFO-MSTP2109A
If you are enrolled onto Group 1: Once you are given the diagnostic agent, the following procedures will be done: PET scans at the approximate times: * 1-4 hours after the injection * 24 hours after the injection (the next day, Day 2) * 48-120 hours after the injection (on either Day 3, 4, or 5) * 144-168 hours after the injection (on either Day 6, 7, or 8) You will also have research bloods drawn on the following times and days, * Day 1: before the injection, approximately 5 minutes after, 30 minutes after, 1 hour after and 2-4 hours after the injection. * At each time of your scheduled PET scan.
DRUG89Zr DFO-MSTP2109A
If you are enrolled onto Group 2: Once you are given the study drug, the following procedures will be done: You will have one PET scan done. The timing of the PET scan will be determined at the time of your enrollment (\ 3-7 days after injection). No research blood work will be drawn in Group 2
Sponsors
Genentech, Inc.
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* To be included in this study, patients should be eligible for enrollment into protocol 11-016 (therapy with the DSTP3086S ADC) or meet all of the following criteria: * Patients meeting the criteria for enrollment on research protocol 11-016 to receive DSTP3086S ADC (therapeutic ADC based on MSTP2109A) will be the preferred patients for this study. Patients that are to receive DSTP3086S will not be injected with DSTP2086S until imaging with 89Zr-DFOMSTP2109A is finished, approximately 1 week. * Adult male \> 21years of age * Visible lesions by either CT, bone scan or MRI consistent with metastatic disease * Metastatic progressive disease * Imaging modalities: * Bone scan: new osseous lesion and/or MRI or CT: An increase in measurable soft tissue disease or the appearance of new sites of disease. Or * PSA changes over range of value 26% * Patients with histologically confirmed prostate cancer at MSKCC * STEAP1 antigen positive tissue known from prior IHC testing or if STEAP1 status is not known archival sample will be sent to Genentech for IHC. Samples need to be positive, when feasible metastatic lesions will be tested preferentially rather than the primary. * Performance status of 60 or higher (Karnofsky scale) (Appendix A) * Ability to understand and willingness to sign a written informed consent document * PSA levels to be taken within 2 weeks of antibody administration.
Exclusion criteria
* Patients meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Histologically Positive Lesions That Are Positive on Imaging | 2 years | Antibody imaging will be considered feasible if 75% of the patients are antibody-imaging-positive. We will enroll 6 patients (cohort 1A) at the 10mg dose level for an initial decision on feasibility. If 4 or more of these patients have 20% or more of their active lesions detectable by 89Zr-DFO-MSTP2109A then we will consider the agent feasible for imaging, otherwise we will proceed to cohort 1B. If the true feasibility rate is 40%, this rule will affords more than 82% chance that cohort 1B will be opened for enrollment; this probability is less than 17% if the true feasibility is 75%. |
| Number of Participants Evaluated for AEs | 2 years | All participants will be evaluated for adverse events which will be graded for intensity on a scale of 0 to 5. Severity grades will be recorded and based on the CTCAE v4.0. Adverse events will be defined graded using CTCAE V4.0. |
| Rate of Clearance of Tracer 89Zr-DFO-MSTP2109A | up to 168 hours | Serial blood draws will be used to estimate the pharmacokinetic profile of the 10mg 89Zr-DFO-MSTP2109A in this patient population. Blood samples will be obtained in green top tube: Just prior to injection of 89Zr-DFO-MSTP2109A (baseline)Approximately 5 ± 2, 15 ± 5, 30 ± 9, 60 ± 19, and 120 to 240 minutes after injection of the tracer. One sample at the time of each subsequent day of imaging (24 + 8h, \ 48-96h and \ 120-168h post injection). |
| Biodistribution/SUVmax | 2 years | A PET-CT scan extending from top of skull to mid thighs will be performed to determine the biodistribution/SUVmax in bone and soft tissue |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Histologically Positive Lesions That Were True Positive on PET Imaging | 2 years | Ability of 89Zr-DFO-MSTP2109A PET to detect sites of metastatic prostate cancer. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 89Zr DFOMSTP2109A Tracer Group 1 The first group of participants will include 6 participants whom will receive 10mg of 89Zr-DFO-MSTP2109A. A second group of 6 participants may receive twice the amount of antibody to determine if this results in better pictures of your tumors. Once we determine whether 10 mg or the larger 20 mg dose of 89Zr-DFOMSTP2109A is best and well tolerated we will use that amount for future participants in Group 2.
89Zr- DFO-MSTP2109A: If you are enrolled onto Group 1:
Once you are given the diagnostic agent, the following procedures will be done:
PET scans at the approximate times:
* 1-4 hours after the injection
* 24 hours after the injection (the next day, Day 2)
* 48-120 hours after the injection (on either Day 3, 4, or 5)
* 144-168 hours after the injection (on either Day 6, 7, or 8) You will also have research bloods drawn on the following times and days,
* Day 1: before the injection, approximately 5 minutes after, 30 minutes after, 1 hour after and 2-4 hours after the injection.
* At each time of your scheduled PET scan. | 19 |
| 89Zr-DFO-MSTP2109A Tracer Group 2 Once we determine whether 10 mg or the larger 20 mg dose of 89Zr-DFOMSTP2109A is best and well tolerated we will use that amount for future participants in Group 2. Group 2 will include up to 15 participants whom may receive a dose of up to 20mg.
89Zr DFO-MSTP2109A: If you are enrolled onto Group 2:
Once you are given the study drug, the following procedures will be done:
You will have one PET scan done. The timing of the PET scan will be determined at the time of your enrollment (\
3-7 days after injection).
No research blood work will be drawn in Group 2 | 0 |
| Total | 19 |
Baseline characteristics
| Characteristic | 89Zr DFOMSTP2109A Tracer Group 1 | Total |
|---|---|---|
| Age, Continuous | 66 years | 66 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 19 Participants |
| Region of Enrollment United States | 19 Participants | 19 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 19 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 0 |
| other Total, other adverse events | 0 / 19 | 0 / 0 |
| serious Total, serious adverse events | 0 / 19 | 0 / 0 |
Outcome results
Primary
Biodistribution/SUVmax
A PET-CT scan extending from top of skull to mid thighs will be performed to determine the biodistribution/SUVmax in bone and soft tissue
Time frame: 2 years
Population: Participants not enrolled to Group 2
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 89Zr DFOMSTP2109A Tracer Group 1 | Biodistribution/SUVmax | SUVmax in bone | 20.6 g/mL |
| 89Zr DFOMSTP2109A Tracer Group 1 | Biodistribution/SUVmax | SUVmax in soft tissue | 16.8 g/mL |
Primary
Number of Participants Evaluated for AEs
All participants will be evaluated for adverse events which will be graded for intensity on a scale of 0 to 5. Severity grades will be recorded and based on the CTCAE v4.0. Adverse events will be defined graded using CTCAE V4.0.
Time frame: 2 years
Population: Participants not enrolled into Group 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 89Zr DFOMSTP2109A Tracer Group 1 | Number of Participants Evaluated for AEs | 19 Participants |
Primary
Percentage of Participants With Histologically Positive Lesions That Are Positive on Imaging
Antibody imaging will be considered feasible if 75% of the patients are antibody-imaging-positive. We will enroll 6 patients (cohort 1A) at the 10mg dose level for an initial decision on feasibility. If 4 or more of these patients have 20% or more of their active lesions detectable by 89Zr-DFO-MSTP2109A then we will consider the agent feasible for imaging, otherwise we will proceed to cohort 1B. If the true feasibility rate is 40%, this rule will affords more than 82% chance that cohort 1B will be opened for enrollment; this probability is less than 17% if the true feasibility is 75%.
Time frame: 2 years
Population: Participants not enrolled into Group 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 89Zr DFOMSTP2109A Tracer Group 1 | Percentage of Participants With Histologically Positive Lesions That Are Positive on Imaging | 86 % of participants with + lesions |
Primary
Rate of Clearance of Tracer 89Zr-DFO-MSTP2109A
Serial blood draws will be used to estimate the pharmacokinetic profile of the 10mg 89Zr-DFO-MSTP2109A in this patient population. Blood samples will be obtained in green top tube: Just prior to injection of 89Zr-DFO-MSTP2109A (baseline)Approximately 5 ± 2, 15 ± 5, 30 ± 9, 60 ± 19, and 120 to 240 minutes after injection of the tracer. One sample at the time of each subsequent day of imaging (24 + 8h, \ 48-96h and \ 120-168h post injection).
Time frame: up to 168 hours
Population: Participants not enrolled to Group 2
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 89Zr DFOMSTP2109A Tracer Group 1 | Rate of Clearance of Tracer 89Zr-DFO-MSTP2109A | 19.7 mL/hour |
Secondary
Percentage of Histologically Positive Lesions That Were True Positive on PET Imaging
Ability of 89Zr-DFO-MSTP2109A PET to detect sites of metastatic prostate cancer.
Time frame: 2 years
Population: Participants not enrolled in Group 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 89Zr DFOMSTP2109A Tracer Group 1 | Percentage of Histologically Positive Lesions That Were True Positive on PET Imaging | 86 % of positive lesions |