Overview
PSMA Imaging of Localized Prostate Cancer
Status:
Completed
Completed
Trial end date:
2018-06-27
2018-06-27
Target enrollment:
0
0
Participant gender:
Male
Male
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Weill Medical College of Cornell UniversityTreatments:
Gallium 68 PSMA-11
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.