Prostate Cancer Patients With Biochemical Recurrence

M

Medhat Osman

Status

Completed

Conditions

Patients With Prostate Cancer

Treatments

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

Study type

Observational

Funder types

Other U.S. Federal agency
Industry

Identifiers

NCT03527199
1201372

Details and patient eligibility

About

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

Full 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.

Enrollment

65 patients

Sex

Male

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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