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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02559115

Run by

Memorial Sloan Kettering Cancer Center

People needed

19

Starts

2015-09-21

Expected to finish

2020-06-18

Last updated by the study team

2021-05-18

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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