Prostate Cancer
Conditions
Keywords
Prostate Cancer
Brief summary
The objective of the study is to evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer.
Detailed description
Primary Objective: To evaluate 68Ga PSMA 11 PET/MRI and 68Ga RM2 PET/MRI for biopsy guidance in patients with suspected prostate cancer. Exploratory Objective: * Correlation of 68Ga PSMA 11 uptake and Gleason score at biopsy * Correlation of 68Ga RM2 and Gleason score at biopsy
Interventions
DRUG68Ga RM2
PET radiopharmaceutical
DRUG68Ga-PSMA-11
PET radiopharmaceutical
DEVICEInvestigational PET scanner coils and software
GE Healthcare non-approved PET scanner coils and software
Sponsors
General Electric
Andrei Iagaru
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Suspected prostate cancer * Planned prostate biopsy * Able to provide written consent * Karnofsky performance status of 50 (or ECOG/WHO equivalent)
Exclusion criteria
* Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam * Metallic implants (contraindicated for MRI)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings | Up to approximately 2 hours to complete each scan | Measure of PET based Biopsy Guidance (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 68Ga PSMA11 First Followed by 68Ga RM2 Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11 and then within two weeks Participant will be injected IV with 140 ±20% mBq of 68Ga RM2. | 7 |
| 68Ga RM2 First Followed by 68Ga PSMA11 Participant will be injected IV with 140 ±20% mBq of 68Ga RM2 and then within two weeks Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA11. | 7 |
| Total | 14 |
Baseline characteristics
| Characteristic | 68Ga PSMA11 First Followed by 68Ga RM2 | Total | 68Ga RM2 First Followed by 68Ga PSMA11 |
|---|---|---|---|
| Age, Continuous | 63.4 years STANDARD_DEVIATION 4.4 | 59.6 years STANDARD_DEVIATION 7.2 | 55.7 years STANDARD_DEVIATION 7.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 14 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 8 Participants | 5 Participants |
| Region of Enrollment United States | 7 Participants | 14 Participants | 7 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 7 Participants | 14 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 13 |
| other Total, other adverse events | 0 / 14 | 0 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 |
Outcome results
Primary
Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings
Measure of PET based Biopsy Guidance (ie, prostate uptake on 68Ga PSMA 11 and 68Ga RM2 scans).
Time frame: Up to approximately 2 hours to complete each scan
Population: Participants who completed both scans and who had biopsy done are included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 68Ga PSMA11 | Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings | 13 Participants |
| 68Ga RM2 | Number of Participants With Biopsy Results Correlated With PET Based Imaging Findings | 13 Participants |