Prostate CancerPhase 2NCT02349022
Comparison of PET With [89Zr]-Df-IAb2M and [111In]-Capromab Pendetide in the Detection of Prostate Cancer Pre-Prostatectomy
A Phase 2 study testing [89Zr]Df-IAB2M in people with Prostate Cancer, run by ImaginAb, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the diagnostic performance of [89Zr]-Df-IAB2M PET/CT with that of [111In]-capromab pendetide as an immuno PET tracer in the detection of prostate cancer pre-prostatectomy as confirmed by pathology. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- [89Zr]Df-IAB2M
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jul 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet ALL criteria listed below for entry:
- Age ≥ 18 years
- Signed, written IRB-approved informed consent
- Patients newly diagnosed with biopsy-proven prostate cancer, thought to be a candidate for prostatectomy after standard diagnostic evaluation (e.g. chest x-ray, CT scan or MRI) who are at high-risk for pelvic lymph node metastases.
- High Risk defined as:
- Gleason score ≥ 8 or
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- Gleason 4+3 with a PSA > 10 or
- PSA > 20 ng/mL or
- T3a
- Patients scheduled for a [111In]-capromab pendetide scan or had a recent [111In]-capromab pendetide scan within 28 days of screening visit or would be willing to undergo a [111In]-capromab pendetide scan
- Karnofsky Performance status of ≥ 60
- Life expectancy of at least 6 months
- Patients with any previous history of another malignancy (other than in-situ cancer, basal or squamous cell skin cancer) must be disease free for a period of three years.
- Acceptable liver function:
- Bilirubin ≤ 1.5 times upper limit of normal or <3 x ULN for patients with Gilbert's disease
- AST (SGOT), ALT (SGPT) and Alkaline phosphatase ≤ 2.5 times upper limit of normal (if liver metastases are present, then ≤ 5 x ULN is allowed)
- Acceptable renal function:
- Serum creatinine within normal limits, OR
- calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- Acceptable hematologic status:
- Granulocyte ≥ 1500 cells/mm3
- Platelet count ≥ 150,000 (plt/mm3)
- Hemoglobin ≥ 9 g/dL
- For men of child-producing potential, the use of effective contraceptive methods during the study
Who cannot join
- Patients will be excluded from entry if ANY of the criteria listed below are met:
- New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months
- Unstable arrhythmia, or evidence of ischemia on ECG
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy for prostate cancer.
- Unwillingness or inability to comply with procedures required in this protocol
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- Known infection with HIV, hepatitis B, or hepatitis C
- Serious nonmalignant disease (eg, hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
- Previous [111In]-capromab pendetide image test
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Urology Specialists
Scottsdale, Arizona, 85255
About this study
Official title: A Phase 2 Study - Comparison Of Positron Emission Tomography (PET/CT) With [89Zr]-Df-IAb2M and [111In]-Capromab Pendetide in the Detection of Prostate Cancer Pre-prostatectomy
The purpose of this study is to compare the diagnostic performance of [89Zr]-Df-IAB2M PET/CT with that of [111In]-capromab pendetide as an immuno PET tracer in the detection of prostate cancer pre-prostatectomy as confirmed by pathology.
Individuals participating in this study will have a [111In]-capromab pendetide scan, as well as a PET scan following the injection of [89Zr]-Df-IAB2M.
Read the detailed description
IAB2M is an approximately 80 kDA molecular weight antibody fragment (a "Minibody") chelated with Desferroxamine and radiolabeled with 89Zr. [89Zr]-Df-IAB2M targets the extracellular domain of Prostate Membrane Specific Antigen (PSMA) expressed on most primary and metastatic prostate cancer lesions.
[111In]-capromab pendetide (Prostascint®) is an FDA approved imaging agent targeting the intracellular domain of PSMA. It is anticipated that [89Zr]-Df-IAB2M will outperform Prostascint® because of this targeting difference.
- Conditions
- Prostate Cancer
- Being tested
- [89Zr]Df-IAB2M
- Keywords
- [89Zr]Df-IAB2M, Prostate cancer, PET scan
- 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]Df-IAB2MRadiation
| Study group | Role | What they receive |
|---|---|---|
| [89Zr]Df-IAB2M | Experimental | A single intravenous infusion of 2.5 mCi of [89Zr]Df-IAB2M in a mass dose of 10 mg. Receives: Radiation: [89Zr]Df-IAB2M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare sensitivity/specificity/PPV/NPV/Accuracy of [111In] capromab pendetide SPECT/CT to [89Zr]-Df-IAB2M PET/CT as confirmed by pathology
Measured: 6 weeks
Secondary outcomes (4)
Assess the safety of a single dose of [89Zr]-Df-IAB2M
Measured: Day 1 through Day 13
Histopathologic correlation of PSMA expression and prostate cancer from surgical or biopsy specimens with uptake of [89Zr]-Df-IAB2M on PET/CT
Measured: Day 1 through Day 13
Compare the concordant and discordant rate for positive/negative areas of uptake between [111In]-Capromab pendetide SPECT/CT to [89Zr]-Df-IAB2M PET/CT using pathology for ground truth of disease status
Measured: Day 1 through Day 13
Compare the sensitivity/specificity/PPV/NPV/Accuracy of conventional imaging (CT/MRI/Bone scan) to [89Zr]-Df-IAB2M PET/CT using pathology for ground truth of disease status
Measured: Day 1 through Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImaginAb, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349022
- Sponsor's protocol ID
- 2014-2M-03.00
- Status last verified
- Aug 2016
- First submitted
- 23 Jan 2015
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study - Comparison Of Positron Emission Tomography (PET/CT) With [89Zr]-Df-IAb2M and [111In]-Capromab Pendetide in the Detection of Prostate Cancer Pre-prostatectomy
- ClinicalTrials.gov ID
- NCT02349022
- Acronym / sponsor ID
- 2014-2M-03.00
- Conditions
- Prostate Cancer
- Keywords
- [89Zr]Df-IAB2M, Prostate cancer, PET scan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- ImaginAb, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Not posted in the source record
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 compare the diagnostic performance of [89Zr]-Df-IAB2M PET/CT with that of [111In]-capromab pendetide as an immuno PET tracer in the detection of prostate cancer pre-prostatectomy as confirmed by pathology.
Individuals participating in this study will have a [111In]-capromab pendetide scan, as well as a PET scan following the injection of [89Zr]-Df-IAB2M.
Detailed description
IAB2M is an approximately 80 kDA molecular weight antibody fragment (a "Minibody") chelated with Desferroxamine and radiolabeled with 89Zr. [89Zr]-Df-IAB2M targets the extracellular domain of Prostate Membrane Specific Antigen (PSMA) expressed on most primary and metastatic prostate cancer lesions.
[111In]-capromab pendetide (Prostascint®) is an FDA approved imaging agent targeting the intracellular domain of PSMA. It is anticipated that [89Zr]-Df-IAB2M will outperform Prostascint® because of this targeting difference.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [89Zr]Df-IAB2M | Experimental | Radiation: [89Zr]Df-IAB2MA single intravenous infusion of 2.5 mCi of [89Zr]Df-IAB2M in a mass dose of 10 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age ≥ 18 years
- Signed, written IRB-approved informed consent
- Patients newly diagnosed with biopsy-proven prostate cancer, thought to be a candidate for prostatectomy after standard diagnostic evaluation (e.g. chest x-ray, CT scan or MRI) who are at high-risk for pelvic lymph node metastases.
- High Risk defined as:
- Patients scheduled for a [111In]-capromab pendetide scan or had a recent [111In]-capromab pendetide scan within 28 days of screening visit or would be willing to undergo a [111In]-capromab pendetide scan
Key exclusion criteria (9 listed)
- New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months
- Unstable arrhythmia, or evidence of ischemia on ECG
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy for prostate cancer.
- Unwillingness or inability to comply with procedures required in this protocol
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]Df-IAB2M | Radiation | [89Zr]Df-IAB2M |
Primary outcome
Compare sensitivity/specificity/PPV/NPV/Accuracy of [111In] capromab pendetide SPECT/CT to [89Zr]-Df-IAB2M PET/CT as confirmed by pathology
Time frame: 6 weeks
4 secondary outcomes
Assess the safety of a single dose of [89Zr]-Df-IAB2M
Time frame: Day 1 through Day 13
Histopathologic correlation of PSMA expression and prostate cancer from surgical or biopsy specimens with uptake of [89Zr]-Df-IAB2M on PET/CT
Time frame: Day 1 through Day 13
Compare the concordant and discordant rate for positive/negative areas of uptake between [111In]-Capromab pendetide SPECT/CT to [89Zr]-Df-IAB2M PET/CT using pathology for ground truth of disease status
Time frame: Day 1 through Day 13
Compare the sensitivity/specificity/PPV/NPV/Accuracy of conventional imaging (CT/MRI/Bone scan) to [89Zr]-Df-IAB2M PET/CT using pathology for ground truth of disease status
Time frame: Day 1 through Day 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [89Zr]Df-IAB2M in people with Prostate Cancer, run by ImaginAb, Inc. 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 24 inclusion and 9 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 13 Feb 2020. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare sensitivity/specificity/PPV/NPV/Accuracy of [111In] capromab pendetide SPECT/CT to [89Zr]-Df-IAB2M PET/CT as confirmed by pathology (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2020.