Clinical Trial · NCT03113617

68Ga-RM2 PET/CT in Detecting Regional Nodal and Distant Metastases in Patients With Intermediate or High-Risk Prostate Cancer

Overview

This phase II trial studies how well gallium Ga 68-labeled gastrin-releasing peptide receptor (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/computed tomography (CT) works in detecting regional nodal and distant metastases in patients with intermediate or high-risk prostate cancer. 68Ga-RM2 PET/CT scan may be able to see smaller tumors than the standard of care CT or magnetic resonance imaging scan.

Sponsor

Stanford University

Phase

Phase 2

Contacts

Andrei Iagaru (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03113617

Drug / Compound

RM2

Isotope(s):

Target(s):

GRPR

Ligand Class: Peptides

Chelator: DOTA

Eligibility

Inclusion

Intermediate to high-risk disease (as determined by elevated PSA \[PSA \> 10\], T-stage \[T2b or greater\], Gleason score \[Gleason score \> 6\] or other risk factors)
Diagnostic CT or magnetic resonance imaging (MRI) performed within 30 days prior to the 68Ga-RM2 PET
Able to provide written consent
Planned prostatectomy with lymph node dissection
Karnofsky performance status of \>= 50 (or Eastern Cooperative Oncology Group \[ECOG\]/World Health Organization \[WHO\] equivalent)
Biopsy proven prostate adenocarcinoma

Exclusion

Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
Inability to lie still for the entire imaging time (approximately 30 minutes)
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)