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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [18F] Fluciclovine PET/MRI | Experimental | [18F] Fluciclovine PET/MRI for pretreatment staging of high-risk prostate cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F] Fluciclovine PET/MRI | Diagnostic Test | [18F] fluciclovine PET/MRI |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Primary Lesions Detected | Number of patients with primary lesions detected on 18-F fluciclovine PET/MRI | 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 | Baseline through 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through 24 hours |
| Follow-up |
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Inclusion Criteria:
- High-risk biopsy-proven treatment-naïve prostate adenocarcinoma (Gleason score ≥ 8 and/or serum PSA > 20)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Galgano, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Medical Center | Birmingham | Alabama | 35249 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33052718 | Derived | Galgano SJ, McDonald AM, Rais-Bahrami S, Porter KK, Choudhary G, Burgan C, Bhambhvani P, Nix JW, Morgan DE, Li Y, Thomas JV, McConathy J. Utility of 18F-Fluciclovine PET/MRI for Staging Newly Diagnosed High-Risk Prostate Cancer and Evaluating Response to Initial Androgen Deprivation Therapy: A Prospective Single-Arm Pilot Study. AJR Am J Roentgenol. 2021 Sep;217(3):720-729. doi: 10.2214/AJR.20.24509. Epub 2020 Oct 14. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | [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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | [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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Primary Lesions Detected | Number of patients with primary lesions detected on 18-F fluciclovine PET/MRI | Posted | Count of Participants | Participants | Baseline through 24 hr |
|
|
Baseline through 8 week follow-up scan
Given that fluciclovine is a FDA clinically approved radiotracer with almost no risk of serious adverse events and all cause mortality, the expected risk of these in this study is effectively 0.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | [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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samuel Galgano | University of Alabama at Birmingham | 2059341388 | samuelgalgano@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2019 | Jan 10, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C117460 | fluciclovine F-18 |
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| [18F] fluciclovine |
| Drug |
[18F] fluciclovine |
|
Changes in primary lesion maximum SUV between pretreatment PET/MRI and followup PET/MRI following 8 weeks of androgen deprivation therapy (ADT) |
| Baseline through 8 weeks |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Number of Patients With Nodal Metastases Detected on Fluciclovine-PET/MRI | Number of patients with nodal metastases detected on [18F]fluciclovine PET/MRI | Posted | Count of Participants | Participants | Baseline through 24 hours |
|
|
|
| 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. | Total number of patients who demonstrated nodal metastatic disease on fluciclovine-PET/MRI | Posted | Count of Participants | Participants | Baseline through 24 hours |
|
|
|
| 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) | Number of patients in total cohort who underwent ADT | Posted | Mean | Standard Deviation | standardized uptake values | Baseline through 8 weeks |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |