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



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/26/2018
Start Date:September 2015
End Date:September 2019
Contact:Herbert Vargas Alvarez, MD
Phone:646-888-5410

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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
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Herbert Vargas Alvarez, MD
Phone: 646-888-5410
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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