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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Device: PET/CT Scan; Radiation: 68Ga-RM2 (RM2)

Study type: Interventional

Funder types: Other

Identifiers

NCT02559115

14-146

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

PET/CT imaging with 68Ga-RM2

Experimental group

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.

Treatment:

Device: PET/CT Scan

Radiation: 68Ga-RM2 (RM2)