PSMA Imaging of Localized Prostate Cancer
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/27/2019 |
| Start Date: | February 8, 2017 |
| End Date: | December 31, 2018 |
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.
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.
The primary endpoint of this study is the proportion of subjects with PSMA-positive
(identified by H&E staining and immunohistochemistry) "dominant" PC lesion(s) greater than
5mm in diameter, whose lesion(s) have been successfully identified by 89Zr-Df-IAB2M imaging.
Because this is an exploratory pilot study, no formal sample size/power calculation is
required. However, with a sample size of 20 patients in the study, a two-sided 95% confidence
interval for the proportion of patients successfully imaged by 89Zr-Df-IAB2M can be
constructed to be within ± 19.0% of the observed proportion of patients with successful
imaging by 89Zr-Df-IAB2M. This calculation assumes an 89Zr-Df-IAB2M imaging-success
proportion of 75%. All estimates from the study will serve as preliminary data (i.e.,
hypothesis-generating) for future studies.
(identified by H&E staining and immunohistochemistry) "dominant" PC lesion(s) greater than
5mm in diameter, whose lesion(s) have been successfully identified by 89Zr-Df-IAB2M imaging.
Because this is an exploratory pilot study, no formal sample size/power calculation is
required. However, with a sample size of 20 patients in the study, a two-sided 95% confidence
interval for the proportion of patients successfully imaged by 89Zr-Df-IAB2M can be
constructed to be within ± 19.0% of the observed proportion of patients with successful
imaging by 89Zr-Df-IAB2M. This calculation assumes an 89Zr-Df-IAB2M imaging-success
proportion of 75%. All estimates from the study will serve as preliminary data (i.e.,
hypothesis-generating) for future studies.
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.
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