Clinical Trial · NCT02424513

A Study of Positron Emission Tomography (PET) With [89]Zr-Df-IAb2M in Patients With High-risk Prostate Cancer

Overview

This is a prospective, multicenter, open-label, non-randomized study evaluating the ability of \[89\]Zr-Df-IAb2M to detect local, regional and metastatic prostate cancer confirmed by pathology.

Sponsor

Imagine AB, Inc.

Phase

Phase 2

Contacts

James Eastham, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02424513

Drug / Compound

IAb2M

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Proteins and Antibody Fragments

Chelator: Desferrioxamine

Eligibility

Inclusion

Patients, who are at high-risk for pelvic lymph node metastasis as defined by a lymph node involvement risk of greater than or equal to 20% using the Briganti nomogram.
Histological diagnosis of prostate adenocarcinoma.
For men of child-producing potential, the use of effective contraceptive methods during the study.
Ability to understand and willingness to sign IRB approved consent form
Patients considered candidates for radical prostatectomy and pelvic lymph node dissection. These patients may or may not have identified nodal metastasis on conventional imaging but would still be candidates for radical prostatectomy and pelvic lymph node dissection.

Exclusion

Unwillingness or inability to comply with procedures required in this protocol.
Patients who are currently receiving any other investigational agent.
Other cancers that might potentially interfere with the reading and interpretation of \[89\]Zr-Df-IAB2M PET/CT scans.
Treatment or plans for treatment with radiation therapy, surgery, chemotherapy, or investigational therapy between the time of conventional imaging, \[89\]Zr-Df-IAB2M PET/CT and the surgical resection or biopsy procedures used for the study evaluation.
Patients who have had or are currently receiving androgen deprivation therapy