Prostate Cancer Patients With Biochemical Recurrence

NCT ID: NCT03527199

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-18
• Study Completion Date: 2023-04-10

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.

Conditions

Patients With Prostate Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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

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

Intervention Type: DIAGNOSTIC_TEST

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.

-

Exclusion Criteria

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Blue Earth Diagnostics

INDUSTRY

Sponsor Role: collaborator

Medhat Osman

FED

Sponsor Role: lead

Responsible Party

Medhat Osman

MD, PhD, Attending Physician at St. Louis VA Healthcare System

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Medhat M Osman, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

St. Louis VA Helathcare System

Locations

John Cochran VA Medical Center St. Louis

St Louis, Missouri, United States

Countries

United States

Other Identifiers

1201372

Identifier Type: -

Identifier Source: org_study_id