A Phase 1/2 interventional study of [18F] Fluciclovine PET/MRI and [18F] fluciclovine in Prostate Cancer, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-09.
Sponsored by University of Alabama at Birmingham · Phase 1/2, Interventional, and Diagnostic
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.
Exclusion Criteria:
\[18F\] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer
Diagnostic Test: [18F] Fluciclovine PET/MRI · Drug: [18F] fluciclovine
\[18F\] fluciclovine PET/MRI
\[18F\] fluciclovine
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
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
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
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
| Milestone | [18F] Fluciclovine PET/MRI |
|---|---|
| Started | 18 |
| Completed | 14 |
| Not completed | 4 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Lost to follow-up | 1 |
Number of patients with primary lesions detected on 18-F fluciclovine PET/MRI
| Participants | [18F] Fluciclovine PET/MRI |
|---|---|
| Number of Patients With Primary Lesions Detected | 14 |
Number of patients with nodal metastases detected on \[18F\]fluciclovine PET/MRI
| Participants | [18F] Fluciclovine PET/MRI |
|---|---|
| Number of Patients With Nodal Metastases Detected on Fluciclovine-PET/MRI | 7 |
Compare number of patients with nodal metastases detected on \[18F\]fluciclovine PET/MRI to number of patients with metastases detected on prostate MRI alone.
| Participants | [18F] Fluciclovine PET/MRI |
|---|---|
| MR alone | 3 |
| PET/MRI | 7 |
Changes in primary lesion maximum SUV between pretreatment PET/MRI and followup PET/MRI following 8 weeks of androgen deprivation therapy (ADT)
| standardized uptake values | [18F] Fluciclovine PET/MRI |
|---|---|
| Pretreatment maximum SUV | 7.1 ± 1.7 |
| Maximum SUV after 8 weeks of ADT | 3.5 ± 2.0 |
Collected over Baseline through 8 week follow-up scan. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| [18F] Fluciclovine PET/MRI | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Categorical(Participants) | [18F] Fluciclovine PET/MRI |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 6 |
| Age, Continuous(years) | [18F] Fluciclovine PET/MRI |
|---|---|
| Mean | 65.6 (50 to 81) |
| Sex: Female, Male(Participants) | [18F] Fluciclovine PET/MRI |
|---|---|
| Female | 0 |
| Male | 14 |
| Race (NIH/OMB)(Participants) | [18F] Fluciclovine PET/MRI |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 7 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | [18F] Fluciclovine PET/MRI |
|---|---|
| United States | 14 |
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University of Alabama at Birmingham