PSMA Imaging of Localized Prostate Cancer

• Status: Completed
• Trial end date: 2018-06-27
• Target enrollment: 0
• Participant gender: 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 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: 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.