Clinical trial NCT03527199: Prostate Cancer Patients With Biochemical Recurrence
Official title: Prospective Comparison of Pelvic CT or MRI Plus Bone Scanning With 99mTc-MDP Bone Scan and/or 18F-NaF PET/CT to 18F- Fluciclovine PET/CT in VA Prostate Cancer Patients With BCR.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With Prostate Cancer
Lead sponsor: Saint Louis VA Medical Center
Sponsor class: FED
Collaborators: name: Blue Earth Diagnostics
First posted: 2018-05-17
Enrollment: 65
Sex: MALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male subjects age 18-89

Brief summary: Evaluation of detection rate of 18F-Fluciclovine compared to current standard of care imaging techniques within 30 days of the standard of care imaging study and a 6 month phone follow-up

Detailed description: When BCR is present, detection of recurrence as well as the location, distribution and number of metastatic sites would determine the choice of subsequent management. In the search of malignancy in patients with BCR, standard of care tests include Pelvic CT or MRI (to look for recurrence and/or pelvic nodal metastases) and a planar bone scan to look for skeletal metastases. However, standard of care testing has a low diagnostic yield of only 11% of patients for visualizing sites of disease (5). Thus, there is a clear need for better imaging approaches. 18F-Fluciclovine is a synthetic amino acid PET tracer approved by the Food and Drug Administration in June of 2016 for the detection of sites of recurrence in men with rising prostate-specific antigen levels after prior primary treatment of prostate cancer (6), based on its diagnostic performance (7,8). However, there is a gap in the literature regarding prospective studies evaluation of detection rate of 18F-Fluciclovine compared to current standard of care imaging techniques. Therefore, 18F-Fluciclovine has already been approved by the FDA and covered CMS and insurance companies but is yet to be included in the NCCN guidelines in the work up of PCa patients with BCR.

Eligibility criteria: Inclusion Criteria:

1. Age \>18 and ≤89
2. History of Prostate Cancer which required surgical resection or radiation
3. Documented Biochemical recurrence defined as a positive PSA any time after the initial diagnosis of prostate cancer which at that time required surgical resection or radiation and then had a negative result to a post treatment PSA.
4. Patient undergoing standard of care work up pelvic CT or MRI, 99mTc-MDP bone scan, and F18 NaF PET/CT.

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Exclusion Criteria:

1. BCR with negative 99mTc-MDP bone scan but 18F-NaF PET/CT was not able to be done.

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Primary outcomes:
measure: In the settings of BCR, detection rate of 18F- Fluciclovine will be compared to that of standard of care (SOC) (pelvic CT or MRI plus 99mTc-MDP bone scan).
timeFrame: 3-6months from acquiring Fluciclovine exam
Secondary outcomes:
measure: In the settings of BCR with negative standard of care 99mTc-MDP bone scan, detection rate of 18F- Fluciclovine wiill be compared to that of standard of care pelvic CT or MRI plus 18F-NaF PET/CT.
timeFrame: 3-6months from acquiring Fluciclovine exam
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: John Cochran VA Medical Center St. Louis
state: Missouri
Study officials:
affiliation: St. Louis VA Helathcare System
name: Medhat M Osman, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: