Clinical Trial · NCT02559115

68Ga-RM2 for PET/CT of Gastrin Releasing Peptide Receptor (GRPr) Expression in Prostate Cancer

Overview

The purpose of this study is to see if a new diagnostic research agent named 68Ga-RM2 can show prostate cancer on a PET/CT scan. 68Ga-RM2 stands for Galium-68 labeled DOTA-4-amino-1-carboxymethylpiperidine-D-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2. This study is being done because there are unmet medical needs to improve the current ways of detecting prostate cancers before surgery.

Sponsor

Memorial Sloan Kettering Cancer Center

Phase

Phase 2

Contacts

Herbert Vargas Alvarez, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02559115

Drug / Compound

RM2

Isotope(s):

Target(s):

GRPR

Ligand Class: Peptides

Chelator: DOTA

Eligibility

Inclusion

Patients with low-risk, intermediate-risk and high-risk tumors according to NCCN guidelines (2.2014) will be included
Planned radical prostatectomy at MSKCC
Multiparametric MRI of the pelvis (performed or planned) as routine care
Biopsy proven adenocarcinoma of the prostate

Exclusion

Patients deemed not surgical candidates due to prohibitive co-morbidities
Platelets \<75K/mcL
Claustrophobia interfering with MRI and PET/CT imaging
Renal laboratory values o Creatinine \> 2.0 x ULN
Prior pelvic radiation
Bilirubin \>2.0 x ULN (institutional upper limits of normal)
Patients meeting any of the following exclusion criteria will not be eligible for study entry:
Hematologic
AST/ALT \>2.5 x ULN
Prior androgen deprivation therapy
ANC \<1.0 K/mcL
Hepatic laboratory values