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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
68Ga-RM2 (RM2)
PET/CT Scan
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring 68Ga-RM2, PET/CT scan, Gastrin Releasing Peptide Receptor (GRPr), 14-146

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET/CT imaging with 68Ga-RM2

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 22, 2015
Last Updated
April 27, 2021
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02559115
Brief Title
68Ga-RM2 for PET/CT of Gastrin Releasing Peptide Receptor (GRPr) Expression in Prostate Cancer
Official Title
A Phase II Study of 68Ga-RM2 for PET/CT of Gastrin Releasing Peptide Receptor (GRPr) Expression in Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 21, 2015 (Actual)
Primary Completion Date
June 18, 2020 (Actual)
Study Completion Date
June 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
68Ga-RM2, PET/CT scan, Gastrin Releasing Peptide Receptor (GRPr), 14-146

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PET/CT imaging with 68Ga-RM2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
68Ga-RM2 (RM2)
Intervention Type
Device
Intervention Name(s)
PET/CT Scan
Primary Outcome Measure Information:
Title
Localizing Tumors
Description
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.
Time Frame
within two weeks prior to the planned prostatectomy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert Vargas Alvarez, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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