Prostate Cancer
Conditions
Keywords
Prostate Cancer
Brief summary
This study is being conducted to determine whether the combination of imaging agents 68-Ga RM2 and 68-Ga PMSA11 is better at assessing response to high intensity focused ultrasound (HIFU) or high dose rate (HDR) local therapy than standard imaging or biopsy in patients with known prostate cancer.
Detailed description
Primary Objective: To determine feasibility of 68Ga-PSMA-11 PET/MRI and 68Ga-RM2 PET/MRI for evaluation of HIFU or HDR local therapy in patients with known prostate cancer.
Interventions
DRUG68-Ga RM2
Radioactive agent
DRUG68-Ga PSMA11
Radioactive agent
Investigational software and coils in PET/MR Scan by General Electric Healthcare
PROCEDUREPET/MRI
Positron emission tomography (PET)/Magnetic resonance imaging (MRI) Scan
Sponsors
General Electric
Andrei Iagaru
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Known prostate cancer * Planned HIFU or HDR local therapy * Able to provide written consent * Karnofsky performance status of 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (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 for Which an Assessment of PET Based Therapeutic Response to HIFU is Successfully Obtained | Up to approximately 2 hours to complete each scan | Positron emission tomography (PET) based of Assessment of Local Therapeutic Response. Therapeutic response to HIFU will be assessed by 68-Ga PSMA 11 and 68-Ga RM2 PET scans. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 68-Ga PSMA11+68-Ga RM2 68-Ga PSMA11 first followed by 68-Ga RM2 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11 | 7 |
| 68-Ga RM2+68-Ga PSMA11 68-Ga RM2 first followed by 68-Ga PSMA11 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11 | 7 |
| Total | 14 |
Baseline characteristics
| Characteristic | 68-Ga PSMA11+68-Ga RM2 | Total | 68-Ga RM2+68-Ga PSMA11 |
|---|---|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 7.5 | 64.5 years STANDARD_DEVIATION 8 | 63.9 years STANDARD_DEVIATION 8.1 |
| 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 | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 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 | 7 Participants | 12 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 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Number of Participants for Which an Assessment of PET Based Therapeutic Response to HIFU is Successfully Obtained
Positron emission tomography (PET) based of Assessment of Local Therapeutic Response. Therapeutic response to HIFU will be assessed by 68-Ga PSMA 11 and 68-Ga RM2 PET scans.
Time frame: Up to approximately 2 hours to complete each scan
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 68-Ga PSMA11 | Number of Participants for Which an Assessment of PET Based Therapeutic Response to HIFU is Successfully Obtained | 14 Participants |
| 68-Ga RM2 | Number of Participants for Which an Assessment of PET Based Therapeutic Response to HIFU is Successfully Obtained | 14 Participants |