Prostate Adenocarcinoma
Conditions
Keywords
high risk, prostate cancer, C11-choline, PET/MR, mpMRI
Brief summary
The purpose of this study is to find out if a PET/MR scan in combination with standard MRI and CT scans can improve the early detection and treatment of patients with prostate cancer.
Detailed description
High risk prostate cancer patients will undergo C11-Choline PET/MR whole body fusion scan and pelvic mpMRI for accurate staging. The PET/MR imaging findings, including the primary lesion with the prostate bed and pelvic lymph nodes, will be correlated with the histopathologic result. Researchers aim to provide accurate one-stop shopping opportunity in diagnosis and staging of high risk prostate cancer using the C11-choline PET/MR scan.
Interventions
DRUGC-11 choline PET tracer
C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table.
DRUGGadobutrol
Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously.
DEVICEPET/MR scanner
C11-PET/MR and pelvic mpMRI scan for prostate cancer.
Sponsors
Mayo Clinic
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
1\. Untreated patients with high-risk and very high-risk prostate cancer, who require clinical pelvic mpMRI, CT, and bone scan as standard clinical care for diagnosis and management of prostate cancer.
Exclusion criteria
1. Patients who already received primary treatment or neo-adjuvant therapy. 2. Patients who refuse undergoing routine clinical imaging (i.e., pelvic mpMRI, CT, bone scan) for staging. Reimbursement of pelvic mpMRI in this study is denied. CT and bone scan may be done elsewhere outside of Mayo Clinic but should be of diagnostic quality. Research C-11 choline PET/MR will not substitute pelvic mpMRI, CT, or bone scan in this study. 3. Patients cannot tolerate MRI (e.g., claustrophobia, severe back pain or spasm, involuntary movement \[e.g., tremor, dystonia\]). 4. Patients have total hip arthroplasty (THA), which can cause substantial susceptibility artifact and degrade image quality of mpMRI. 5. Patients have cardiac pacemaker, cochlear implants, neurostimulator, medical device which is unsafe at 3 Tesla, or foreign metallic body in the eyes or orbit. 6. Patients have contraindication to gadolinium based MR contrast agents (e.g., renal failure, severe reaction to gadolinium based MR contrast agents). Epidermal growth factor receptor (eGFR) should be above 30 within 30 days the time of mpMRI.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uptake Value of C11-choline | Baseline | Measured by maximum standardized uptake value (SUVmax) of indexed lesions. SUV is calculated as ratio of concentration of tissue reactivity divided by dose at time of injection divided by body weight. |
| Number of Lesions Showing C11-Choline Uptake | Baseline | Measured by the mean number of lesions to show C11-Choline uptake. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High Risk Prostate Cancer Patients Subjects will receive C-11 choline PET Tracer and Gadobutrol prior to the one time Positron emission tomography (PET/MR scanner) imaging and Multiparametric Magnetic resonance imaging (mpMRI).
C-11 choline PET tracer: C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table.
Gadobutrol: Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously.
PET/MR scanner: C11-PET/MR and pelvic mpMRI scan for prostate cancer. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | High Risk Prostate Cancer Patients | — |
|---|---|---|
| Age, Continuous | 63.9 years STANDARD_DEVIATION 6 | — |
| Race and Ethnicity Not Collected | — | — 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 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Number of Lesions Showing C11-Choline Uptake
Measured by the mean number of lesions to show C11-Choline uptake.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Risk Prostate Cancer Patients | Number of Lesions Showing C11-Choline Uptake | 1.2 Lesions | Standard Deviation 0.4 |
Primary
Uptake Value of C11-choline
Measured by maximum standardized uptake value (SUVmax) of indexed lesions. SUV is calculated as ratio of concentration of tissue reactivity divided by dose at time of injection divided by body weight.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Risk Prostate Cancer Patients | Uptake Value of C11-choline | 6.2 Ratio | Standard Deviation 1.8 |