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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Radiation: 68Ga-RM2 (RM2); Device: PET/CT Scan

• Registration Number: NCT02559115
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-21
• Study First Submitted: 2015-09-22
• Study First Submitted QC: 2015-09-22
• Study First Posted: 2015-09-24
• Status Verified: 2020-06
• Primary Completion: 2020-06-18
• Study Completion: 2020-06-18
• Results First Submitted: 2021-04-27
• Results First Submitted QC: 2021-04-27
• Last Update Submitted: 2021-04-27
• Results First Posted: 2021-05-18
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET/CT imaging with 68Ga-RM2	PET/CT Scan	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.
PET/CT imaging with 68Ga-RM2	68Ga-RM2 (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.

Primary Outcome Measures

Name	Time	Method
Localizing Tumors	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States