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

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: 68Ga-RM2 (RM2)
* Device: PET/CT Scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET/CT imaging with 68Ga-RM2<br>The intervention is the administration of a single dose of 150-200 MBq 68Ga-RM2 (mass <= 30 μg) for imaging purposes. This will be followed by a 30-40 min PET/CT study after a waiting period of 60 min (+/- 10 min). Prior clinical experience suggests that imaging can be performed within 1 hour post injection (27, 28). MR imaging and prostatectomy will be performed as standard of care at MSKCC. | Radiation: 68Ga-RM2 (RM2)<br> <br> Device: PET/CT Scan<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Localizing Tumors | Localization will be defined using a total of 12 regions within the prostate: right and left base, midgland and apex in both peripheral and transition zones. The uptake on each region will be assessed by a radiologist blinded to standard of care imaging and clinical characteristics. Histopathological confirmation will be used as the gold standard. | within two weeks prior to the planned prostatectomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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14-146, Gastrin Releasing Peptide Receptor (GRPr), 68Ga-RM2, PET/CT scan