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

April 27, 2021 updated by: Memorial Sloan Kettering Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET/CT imaging with 68Ga-RM2
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.
Device: PET/CT Scan
Radiation: 68Ga-RM2 (RM2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Localizing Tumors
Time Frame: within two weeks prior to the planned prostatectomy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Herbert Vargas Alvarez, MD, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2015

Primary Completion (Actual)

June 18, 2020

Study Completion (Actual)

June 18, 2020

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimate)

September 24, 2015

Study Record Updates

Last Update Posted (Actual)

May 18, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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