Prostate Cancer Patients With Biochemical Recurrence

Medhat Osman65 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Patients With Prostate Cancer

Interventions

Pelvic CT or MRI + MDP bone scan + or - 18F-NaF PET/CT(SOC)DIAGNOSTIC_TEST

Standard of care-Pelvic CT or MRI and MDP bone scan + or - 18F-NaF PET/CT

Eligibility

Sex: MALEMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (1)

John Cochran VA Medical Center St. Louis

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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).

Detection rate of 18F- Fluciclovine PET/CT will be compared to current standard of care imaging with or without 18F-NaF PET/CT based on all available clinical follow up data including histological reference standard when biopsy of suspected lesion(s) is performed.

Time frame: 3-6months from acquiring Fluciclovine exam

Secondary Outcomes

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.

In the setting of PCa patients with BCR, documenting a higher detection rate for 18F- Fluciclovine PET/CT compared to current standard of care imaging modalities could result in future use of 18F- Fluciclovine PET/CT as a "one stop shop" for those patients.

Time frame: 3-6months from acquiring Fluciclovine exam

Data from ClinicalTrials.gov

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