Phase 2
N=20
PSMA Imaging of Localized Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03675451 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: 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 — 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 89ZR-DF-IAB2M (Drug); 68Ga-PSMA-HBED-CC (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
18 | — |
| PRIMARY 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 |
9 | — |
| SECONDARY The Number of Clinically-significant Lesions Detected by 89Zr-df-IAb2M PET/CT |
22 | — |
| SECONDARY The Number of Clinically Significant Lesions Detected by 68Ga-PSMA-HBED-CC PET/CT |
10 | — |
| SECONDARY The Number of Clinically Significant Lesions Detected by mpMRI |
18 | — |
| SECONDARY The Number of Clinically Significant Lesions Detected by mpMRI in the Subset of Subjects Who Underwent 68Ga-PSMA-HBED-CC PET/CT |
8 | — |
| SECONDARY 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 |
9 | — |
| SECONDARY The Number of Lesions Involved in Extra-prostatic Extension Identified Through in Vivo 89Zr-df-IAB2M PET/CT |
9 | — |
| SECONDARY The Number of Lesions Involved in Extra-prostatic Extension Identified Through 68Ga-PSMA-HBED-CC PET/CT |
4 | — |
| SECONDARY The Number of Occult Lymph Nodes Identified by in Vivo 89Zr-df-IAB2M PET/CT |
7 | — |
| SECONDARY The Number of Occult Lymph Nodes Identified by in Vivo 68Ga-PSMA-11 PET/CT |
2 | — |
| SECONDARY The Number of Observed or Reported Treatment-Emergent Adverse Events Following 89ZR-DF-IAB2M PET/CT (Positron Emission Tomography-Computed Tomography) |
— | — |
| SECONDARY The Number of Observed or Reported Treatment-Emergent Adverse Events Following 68Ga-PSMA-HBED-CC PET/CT |
— | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03675451). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.