Prostate Cancer Clinical Trial
Official title:
PSMA Imaging of Localized Prostate Cancer
Verified date | September 2020 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 27, 2018 |
Est. primary completion date | June 27, 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | 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 | |
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 | 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 | Up to 30 days pre-prostatectomy | |
Secondary | The Number of Clinically-significant Lesions Detected by 89Zr-df-IAb2M PET/CT | Up to 30 days pre-prostatectomy | ||
Secondary | The Number of Clinically Significant Lesions Detected by 68Ga-PSMA-HBED-CC PET/CT | 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 | |
Secondary | The Number of Clinically Significant Lesions Detected by mpMRI | pre-prostatectomy standard of care mpMRI used to determine the number of clinically significant lesions | Up to 30 days pre-prostatectomy | |
Secondary | The Number of Clinically Significant Lesions Detected by mpMRI in the Subset of Subjects Who Underwent 68Ga-PSMA-HBED-CC PET/CT | 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 | |
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 | 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 | Up to 30 days pre-prostatectomy | |
Secondary | The Number of Lesions Involved in Extra-prostatic Extension Identified Through in Vivo 89Zr-df-IAB2M PET/CT | Up to 30 days pre-prostatectomy | ||
Secondary | The Number of Lesions Involved in Extra-prostatic Extension Identified Through 68Ga-PSMA-HBED-CC PET/CT | Up to 30 days pre-prostatectomy | ||
Secondary | The Number of Occult Lymph Nodes Identified by in Vivo 89Zr-df-IAB2M PET/CT | Up to 30 days pre-prostatectomy | ||
Secondary | The Number of Occult Lymph Nodes Identified by in Vivo 68Ga-PSMA-11 PET/CT | Up to 30 days pre-prostatectomy | ||
Secondary | The Number of Observed or Reported Treatment-Emergent Adverse Events Following 89ZR-DF-IAB2M PET/CT (Positron Emission Tomography-Computed Tomography) | All AEs, including unrelated AEs, expected, and unexpected AEs were included in the counts of adverse events | Up to 30 days pre-prostatectomy | |
Secondary | The Number of Observed or Reported Treatment-Emergent Adverse Events Following 68Ga-PSMA-HBED-CC PET/CT | 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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