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Completed

NCT Number: NCT02559115

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

68Ga-RM2 (RM2)

Radiation

PET/CT Scan

Device

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Sep 24, 2015
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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