Prostate Cancer
Conditions
Brief summary
There is great need for improved preoperative imaging in men with high-risk prostate cancer. Investigators propose to develop and validate an optimized simultaneous PET/MRI protocol for local, regional and whole body preoperative staging in a single imaging session using the amino acid PET tracer, F-18 fluciclovine. Despite advances in the diagnosis and treatment of prostate cancer, the preoperative staging of men with prostate carcinoma (PCa) is currently problematic. Conventional imaging is falsely negative for regional lymph node metastases in a substantial fraction of men. In particular, approximately 35% of men with high-risk prostate cancer will have biochemical recurrence even after optimal surgical resection. A major benefit of simultaneous acquisition of a multiparametric prostate MRI (mpMRI) and F-18 fluciclovine PET includes having the patient undergo a single imaging study which provides both anatomic and molecular characterization of the tumor, including metastases which would potentially be missed by conventional anatomic imaging and size criteria. Additionally, simultaneous acquisition will improve co-registration of the PET and MR data which is valuable for small lesions and in anatomically complex regions. Although the use of fluciclovine in the characterization of the primary PCa remains to be established, the anatomic detail provided by conventional mpMRI will complement the detection of small volume metastatic disease by fluciclovine PET. Additionally, the use of hybrid PET/MRI technology allows for the assessment of dynamic tracer uptake and washout during the whole body and regional PET/MRI scan, which may demonstrate the ability to increase detection of the primary PCa on fluciclovine PET. If F-18 fluciclovine PET/MRI can reliably and accurately detect nodal metastases in high-risk prostate cancer patients, surgeons may use this new technology to develop new treatment algorithms for the optimal management of these patients.
Interventions
DIAGNOSTIC_TEST[18F] Fluciclovine PET/MRI
\[18F\] fluciclovine PET/MRI
DRUG[18F] fluciclovine
\[18F\] fluciclovine
Sponsors
University of Alabama at Birmingham
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
\- High-risk biopsy-proven treatment-naïve prostate adenocarcinoma (Gleason score ≥ 8 and/or serum PSA \> 20)
Exclusion criteria
* Inability to tolerate or undergo PET/MRI * Previous or current hematologic or lymphatic disorder (including leukemia, lymphoma, Castleman's disease, etc.) * Recurrent prostate adenocarcinoma * Known visceral, osseous, or extrapelvic metastases prior to fluciclovine-PET/MRI * Known allergy to glucagon or gadolinium-based contrast
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Primary Lesions Detected | Baseline through 24 hr | Number of patients with primary lesions detected on 18-F fluciclovine PET/MRI |
| Number of Patients With Nodal Metastases Detected on Fluciclovine-PET/MRI | Baseline through 24 hours | Number of patients with nodal metastases detected on \[18F\]fluciclovine PET/MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI | Baseline through 24 hours | Compare number of patients with nodal metastases detected on \[18F\]fluciclovine PET/MRI to number of patients with metastases detected on prostate MRI alone. |
| Follow-up | Baseline through 8 weeks | Changes in primary lesion maximum SUV between pretreatment PET/MRI and followup PET/MRI following 8 weeks of androgen deprivation therapy (ADT) |
Countries
United States
Participant flow
Pre-assignment details
Three consented patients chose not to undergo the initial PET/MRI scan prior to the scan being performed. Additionally, one patient's images were lost to data corruption and the patient was not included in the final analysis.
Participants by arm
| Arm | Count |
|---|---|
| [18F] Fluciclovine PET/MRI \[18F\] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer
\[18F\] Fluciclovine PET/MRI: \[18F\] fluciclovine PET/MRI
\[18F\] fluciclovine: \[18F\] fluciclovine | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | [18F] Fluciclovine PET/MRI |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 65.6 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 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 | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Number of Patients With Nodal Metastases Detected on Fluciclovine-PET/MRI
Number of patients with nodal metastases detected on \[18F\]fluciclovine PET/MRI
Time frame: Baseline through 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| [18F] Fluciclovine PET/MRI | Number of Patients With Nodal Metastases Detected on Fluciclovine-PET/MRI | 7 Participants |
Primary
Number of Patients With Primary Lesions Detected
Number of patients with primary lesions detected on 18-F fluciclovine PET/MRI
Time frame: Baseline through 24 hr
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| [18F] Fluciclovine PET/MRI | Number of Patients With Primary Lesions Detected | 14 Participants |
Secondary
Follow-up
Changes in primary lesion maximum SUV between pretreatment PET/MRI and followup PET/MRI following 8 weeks of androgen deprivation therapy (ADT)
Time frame: Baseline through 8 weeks
Population: Number of patients in total cohort who underwent ADT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| [18F] Fluciclovine PET/MRI | Follow-up | Pretreatment maximum SUV | 7.1 standardized uptake values | Standard Deviation 1.7 |
| [18F] Fluciclovine PET/MRI | Follow-up | Maximum SUV after 8 weeks of ADT | 3.5 standardized uptake values | Standard Deviation 2 |
Secondary
Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI
Compare number of patients with nodal metastases detected on \[18F\]fluciclovine PET/MRI to number of patients with metastases detected on prostate MRI alone.
Time frame: Baseline through 24 hours
Population: Total number of patients who demonstrated nodal metastatic disease on fluciclovine-PET/MRI
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| [18F] Fluciclovine PET/MRI | Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI | MR alone | 3 Participants |
| [18F] Fluciclovine PET/MRI | Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI | PET/MRI | 7 Participants |