NCT03675451

PSMA Imaging of Localized Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	89ZR-DF-IAB2M	injection of 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT scan
DRUG	68Ga-PSMA-HBED-CC	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.

Timeline

• Start date: 2017-02-08
• Primary completion: 2018-06-27
• Completion: 2018-06-27
• First posted: 2018-09-18
• Last updated: 2020-10-14
• Results posted: 2020-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study