- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03675451
PSMA Imaging of Localized Prostate Cancer
The present study is a phase II, open label, single-center, non-randomized, single-dose study.
Twenty subjects in total will be enrolled at Weill Cornell Medical College (WCMC)/ NYPH.
The primary objective is to evaluate the ability of 89Zr-Df-IAB2M to detect localized, clinically significant (defined as: ≥ 0.5 cm3 with Gleason pattern ≥ 4) prostate cancer (PCa).
After the screening period (up to 28 days), each subject will be scheduled to receive 10 mg infusion of IAB2M conjugated with 2.5 mCi 89Zr-Df.
2 - 4 days post-infusion, subjects will undergo a 89Zr-Df-IAB2M PET/CT scan. Images read by a Nuc Med MD reporting: location, SUV and, if possible, size of all areas with abnormal uptake.
(they will also undergo a pelvic MRI if they have not obtained an MR image during the screening period or on day of infusion)
Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance.
Patient will undergo radical prostatectomy after completion of above imaging procedures.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
New York
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New York, New York, United States, 10065
- Weill Cornell Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed localized prostate cancer that are scheduled to undergo radical prostatectomy.
- Age >18 years.
Patients must have laboratory values consistent with eligibility to undergo a radical prostatectomy:
- creatinine less than or equal to 1.5 X upper limit of normal
- creatinine clearance > 60 mL/min
- The effects of 89Zr-Df-IAB2M on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while her male partner is participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Treatment or plans for treatment with radiation therapy, surgery, chemotherapy, or investigational therapy between the time of conventional imaging, 89Zr-Df-IAB2M PET/CT and the surgical resection used for the study evaluation.
- Transrectal prostate biopsy performed less than four weeks prior to 89Zr-Df-IAB2M administration.
- Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interventional
Injection of study drug followed by PET/CT imaging. Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance. Followed by prostatectomy |
injection of 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT scan
Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Number of Subjects With PSMA-positive (Prostate-specific Membrane Antigen) "Dominant" PC Lesion(s) Greater Than 5mm in Diameter, Whose Lesion(s) Have Been Successfully Identified by 89Zr-df-IAB2M PET/CT
Time Frame: Up to 30 days pre-prostatectomy
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The number of subjects whose lesions have been successfully identified through 89Zr-df-IAB2M PET/CT will be ascertained using a combination of the descriptive statistics and lesion-based analysis, which both utilize multiple measurements
|
Up to 30 days pre-prostatectomy
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The Number of Subjects With PSMA-positive "Dominant" PC Lesion(s) Greater Than 5mm in Diameter, Whose Lesion(s) Have Been Successfully Identified by 68Ga-PSMA-HBED-CC PET/CT
Time Frame: Up to 30 days pre-prostatectomy
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The number of subjects with PSMA-positive (prostate-specific membrane antigen) "dominant" PC lesion(s) greater than 5mm in diameter, whose lesion(s) have been successfully identified by 68Ga-PSMA-HBED-CC PET/CT
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Up to 30 days pre-prostatectomy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Number of Clinically-significant Lesions Detected by 89Zr-df-IAb2M PET/CT
Time Frame: Up to 30 days pre-prostatectomy
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Up to 30 days pre-prostatectomy
|
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The Number of Clinically Significant Lesions Detected by 68Ga-PSMA-HBED-CC PET/CT
Time Frame: Up to 30 days pre-prostatectomy
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Participants underwent 68Ga-PSMA-HBED-CC injection and PET/CT scan (1 to 3 hours after the injection),e performed prior to radical prostatectomy.
|
Up to 30 days pre-prostatectomy
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The Number of Clinically Significant Lesions Detected by mpMRI
Time Frame: Up to 30 days pre-prostatectomy
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pre-prostatectomy standard of care mpMRI used to determine the number of clinically significant lesions
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Up to 30 days pre-prostatectomy
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The Number of Clinically Significant Lesions Detected by mpMRI in the Subset of Subjects Who Underwent 68Ga-PSMA-HBED-CC PET/CT
Time Frame: Up to 30 days pre-prostatectomy
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The Number of Clinically Significant Lesions Detected by mpMRI in subjects who underwent 68Ga-PSMA-HBED-CC injection and PET/CT
|
Up to 30 days pre-prostatectomy
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The Number of Clinically Significant Lesions Detected by 89Zr-df-IAB2M PET/CT in the Subset of Subjects Who Underwent 68Ga-PSMA-HBED-CC PET/CT
Time Frame: Up to 30 days pre-prostatectomy
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The Number of clinically significant lesions detected by 89Zr-df-IAB2M PET/CT in the subset of subjects who underwent 68Ga-PSMA-HBED-CC Injection and PET/CT
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Up to 30 days pre-prostatectomy
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The Number of Lesions Involved in Extra-prostatic Extension Identified Through in Vivo 89Zr-df-IAB2M PET/CT
Time Frame: Up to 30 days pre-prostatectomy
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Up to 30 days pre-prostatectomy
|
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The Number of Lesions Involved in Extra-prostatic Extension Identified Through 68Ga-PSMA-HBED-CC PET/CT
Time Frame: Up to 30 days pre-prostatectomy
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Up to 30 days pre-prostatectomy
|
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The Number of Occult Lymph Nodes Identified by in Vivo 89Zr-df-IAB2M PET/CT
Time Frame: Up to 30 days pre-prostatectomy
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Up to 30 days pre-prostatectomy
|
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The Number of Occult Lymph Nodes Identified by in Vivo 68Ga-PSMA-11 PET/CT
Time Frame: Up to 30 days pre-prostatectomy
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Up to 30 days pre-prostatectomy
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The Number of Observed or Reported Treatment-Emergent Adverse Events Following 89ZR-DF-IAB2M PET/CT (Positron Emission Tomography-Computed Tomography)
Time Frame: Up to 30 days pre-prostatectomy
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All AEs, including unrelated AEs, expected, and unexpected AEs were included in the counts of adverse events
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Up to 30 days pre-prostatectomy
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The Number of Observed or Reported Treatment-Emergent Adverse Events Following 68Ga-PSMA-HBED-CC PET/CT
Time Frame: Up to 30 days pre-prostatectomy
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All AEs, including unrelated AEs, expected, and unexpected AEs were included in the counts of adverse events
|
Up to 30 days pre-prostatectomy
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Collaborators and Investigators
Investigators
- Principal Investigator: Douglas S Scherr, MD, Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1311014489
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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