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

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

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.

Inclusion Criteria:

• Age ≥18 years
• Biopsy proven adenocarcinoma of the prostate
• 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

Exclusion Criteria:

• Patients meeting any of the following exclusion criteria will not be eligible for study entry:

• Hematologic

  • Platelets <75K/mcL
  • ANC <1.0 K/mcL

• Hepatic laboratory values

  • Bilirubin >2.0 x ULN (institutional upper limits of normal)
  • AST/ALT >2.5 x ULN

• Renal laboratory values

  o Creatinine > 2.0 x ULN

• Claustrophobia interfering with MRI and PET/CT imaging

• Prior pelvic radiation

• Prior androgen deprivation therapy

• Patients deemed not surgical candidates due to prohibitive co-morbidities