Clinical trial · Interventional
68Ga-RM2 for PET/CT of Gastrin Releasing Peptide Receptor (GRPr) Expression in Prostate Cancer
A Phase II Study of 68Ga-RM2 for PET/CT of Gastrin Releasing Peptide Receptor (GRPr) Expression in Prostate Cancer
NCT02559115CI-TRIAL-00051879completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-RM2 (RM2) | Radiation | — | UNRESOLVED |
| PET/CT Scan | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PET/CT imaging with 68Ga-RM2
- 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.
- interventionNames
- Radiation: 68Ga-RM2 (RM2)
- Device: PET/CT Scan
Primary outcomes (1)
- measure
- Localizing Tumors
- timeFrame
- within two weeks prior to the planned prostatectomy
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.