Prostate CancerPhase 1/2NCT01774071
Study of 89Zr-DFO-MSTP2109A in Patients With Prostate Cancer
A Phase 1/2 study testing 89Zr- DFO-MSTP2109A and 89Zr DFO-MSTP2109A in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 89Zr- DFO-MSTP2109A and 89Zr DFO-MSTP2109A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 2 May 2023
- Phase
- Phase 1/2
- 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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 14Show fewer
- 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.
Who cannot join
- Patients meeting any of the following exclusion criteria will not be eligible for study entry:
- Previous anaphylactic reaction to human, humanized or chimeric antibody
- Hematologic
- Platelets <75K/mcL
- ANC <1.0 K/mcL
- Hepatic laboratory values
Show all 11Show fewer
- AST/ALT >2.5 x ULN
- Renal laboratory values
- Bilirubin >1.5 x ULN (institutional upper limits of normal)
- eGFR < 30mL/min/1.73m2
- Patients with history of hypersensitivity reaction to any component of 89Zr-DFOMSTP2109A, including DFO
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Phase I/II Study of 89Zr-DFO-MSTP2109A in Patients With Prostate Cancer
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.
- Conditions
- Prostate Cancer
- Being tested
- 89Zr- DFO-MSTP2109A, 89Zr DFO-MSTP2109A
- Keywords
- 89Zr-DFO-MSTP2109A, tracer, pet scan, 12-178
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr- DFO-MSTP2109ADrug
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.
89Zr DFO-MSTP2109ADrug
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
| Study group | Role | What they receive |
|---|---|---|
| 89Zr DFOMSTP2109A tracer Group 1 | Experimental | 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. Receives: Drug: 89Zr- DFO-MSTP2109A |
| 89Zr-DFO-MSTP2109A tracer Group 2 | Experimental | 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. Receives: Drug: 89Zr DFO-MSTP2109A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 2 years
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.
Measured: 2 years
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).
Measured: up to 168 hours
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
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startJan 2013
- Primary completion2 May 2023
- Study completion2 May 2023
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Steven Larson, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774071
- Sponsor's protocol ID
- 12-178
- Status last verified
- May 2024
- First submitted
- 11 Jan 2013
- Last updated
- 2 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Martiniova L, Zielinski RJ, Lin M, DePalatis L, Ravizzini GC. The Role of Radiolabeled Monoclonal Antibodies in Cancer Imaging and ADC Treatment. Cancer J. 2022 Nov-Dec 01;28(6):446-453. doi: 10.1097/PPO.0000000000000625.
PubMed 36383907
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of 89Zr-DFO-MSTP2109A in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT01774071
- Acronym / sponsor ID
- 12-178
- Conditions
- Prostate Cancer
- Keywords
- 89Zr-DFO-MSTP2109A, tracer, pet scan, 12-178
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jan 2013
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Posted 2 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 89Zr DFOMSTP2109A tracer Group 1 | Experimental | Drug: 89Zr- DFO-MSTP2109AThe 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 tracer Group 2 | Experimental | Drug: 89Zr DFO-MSTP2109AOnce 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (11 listed)
- Patients meeting any of the following exclusion criteria will not be eligible for study entry:
- Previous anaphylactic reaction to human, humanized or chimeric antibody
- Hematologic
- Platelets <75K/mcL
- ANC <1.0 K/mcL
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 |
|---|---|---|
| 89Zr- DFO-MSTP2109AIf 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. | Drug | 89Zr DFOMSTP2109A tracer Group 1 |
| 89Zr DFO-MSTP2109AIf 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 | Drug | 89Zr-DFO-MSTP2109A tracer Group 2 |
Primary outcome
Percentage of Participants With Histologically Positive Lesions That Are Positive on Imaging
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
1 secondary outcome
Percentage of Histologically Positive Lesions That Were True Positive on PET Imaging
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36383907Martiniova L, Zielinski RJ, Lin M, DePalatis L, Ravizzini GC. The Role of Radiolabeled Monoclonal Antibodies in Cancer Imaging and ADC Treatment. Cancer J. 2022 Nov-Dec 01;28(6):446-453. doi: 10.1097/PPO.0000000000000625.
- Memorial Sloan Kettering 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.
Steven Larson, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 89Zr- DFO-MSTP2109A and 89Zr DFO-MSTP2109A in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 14 inclusion and 11 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: finished, as of the sponsor's last update on 2 Oct 2024. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 2 Oct 2024). 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?
Percentage of Participants With Histologically Positive Lesions That Are Positive on Imaging (time frame: 2 years). The study lists 4 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 NCT01774071, which also lists 1 linked publication.
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 2 Oct 2024.