Phase 2
Completed N=19
68Ga-RM2 for PET/CT of Gastrin Releasing Peptide Receptor (GRPr) Expression in Prostate Cancer
Source: ClinicalTrials.gov NCT02559115 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Localizing Tumors — 128; 64 Areas of the body
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Localizing Tumors |
128; 64 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT02559115). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.