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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02559115
• Other study ID #: 14-146
• Status: Completed
• Phase: Phase 2
• Start date: September 21, 2015
• Est. completion date: June 18, 2020

Study information

• Verified date: June 2020
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 18, 2020
• Est. primary completion date: June 18, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• 68Ga-RM2 (RM2)

Device:
• PET/CT Scan

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center