Prostate Cancer
Conditions
Keywords
68Ga-RM2, PET/CT scan, Gastrin Releasing Peptide Receptor (GRPr), 14-146
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.
Interventions
RADIATION68Ga-RM2 (RM2)
DEVICEPET/CT Scan
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PET/CT Imaging With 68Ga-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.
68Ga-RM2 (RM2)
PET/CT Scan | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | PET/CT Imaging With 68Ga-RM2 |
|---|---|
| Age, Continuous | 60 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 19 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 6 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
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.
Time frame: within two weeks prior to the planned prostatectomy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PET/CT Imaging With 68Ga-RM2 | Localizing Tumors | Containing cancer | 128 Areas of the body |
| PET/CT Imaging With 68Ga-RM2 | Localizing Tumors | Not containing cancer | 64 Areas of the body |