The Impact of 18F Fluciclovine (FACBC) PET/CT (Positron Emission Computed Tomography) on Management of Patients With Rising PSA (Prostate-specific Antigen) After Initial Prostate Cancer Treatment


Condition: Prostate Cancer

Intervention:

  • Drug: 18F-fluciclovine PET CT

Purpose: This prospective study will enroll up to 330 men with PSA-persistent or PSA-recurrent prostate cancer after curative-intent primary therapy and negative or equivocal findings on standard-of-care imaging. Consenting participants will be imaged with 18F-fluciclovine PET/CT. Site clinicians will manage study subjects per standard practices and will document any change in treatment based on review of 18F-fluciclovine PET/CT findings. All participants will be followed for up to 6 months, with clinical data collected for this study. An interdisciplinary panel will provide expert guidance to local readers on request. The final reporting of the PET/CT scan will be a single report by the local reader following any such discussion.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02680041

Sponsor: Blue Earth Diagnostics

Primary Outcome Measures:

  • Measure: The fraction of patients for whom 18F-fluciclovine PET/CT alters patient planned treatment through detection of disease.
  • Time Frame: 2-22 days post PET CT
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: The fraction of patients for whom 18F-fluciclovine PET/CT alters patient actual treatment
  • Time Frame: 6 months
  • Safety Issue:
  • Measure: The rate of detection of any disease site by 18F-fluciclovine PET/CT in the study population
  • Time Frame: 1 week
  • Safety Issue:
  • Measure: The rate of detection of 1) local and pelvic disease and 2) distant metastases with 18F-fluciclovine PET/CT in the study population
  • Time Frame: 1 week
  • Safety Issue:
  • Measure: The Positive Predictive Value (PPV) of 18F-fluciclovine PET/CT for regional disease compared to biopsy in those patients who undergo biopsy or in case of bony disease a correlation with MRI or biopsy
  • Time Frame: 6 months
  • Safety Issue:
  • Measure: The PPV of 18F-fluciclovine PET/CT for distant disease compared to biopsy in those patients who undergo a biopsy or in case of bony disease a correlation with MRI or biopsy
  • Time Frame: 6 months
  • Safety Issue:

Estimated Enrollment: 220

Study Start Date: May 2016

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • History of histologically confirmed adenocarcinoma of the prostate post curative-intent local treatment (radical prostatectomy, local radiotherapy, brachytherapy).
  • Suspicion of recurrent prostate carcinoma after previous presumed definitive therapy for organ confined disease defined as :
  • Post prostatectomy: Detectable or rising PSA level that is >0.2 ng/mL with a second confirmatory level of >0.2 ng/mL
  • Post non-prostatectomy: PSA rise ≥ 2ng/mL over nadir
  • Negative or equivocal findings on standard-of-care imaging for restaging of disease in the previous 60 days consisting of: Whole-body 99mTc bone scintigraphy or NaF PET-CT; and either CT or MRI of the pelvis (or the abdomen and pelvis).
  • Being considered for salvage therapy
  • Any non-surgical local treatment such as previous cryotherapy, external beam radiation, or HiFU (Ultrasound) must have occurred at least 1 year in the past.
  • Previous brachytherapy treatment will have occurred at least 2 years in the past
  • Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

  • Ongoing treatment with any systemic therapy intended for the treatment of prostate cancer (e.g., antiandrogen or LHRH agonist or antagonist)
  • Androgen deprivation therapy (ADT) in the past 3 months
  • History of bilateral orchidectomy
  • Inability to tolerate 18F-fluciclovine PET/CT

Locations:

  • City of Hope National Medical Center
  • Duarte California 91010 United States
  • Cedars-Sinai Medical Center
  • Los Angeles California 90048 United States
  • Tower Urology
  • Los Angeles California 90048 United States
  • Genesis Research, LLC
  • San Diego California 92123 United States
  • University of Florida
  • Jacksonville Florida 32209 United States
  • Loyola University Medical Center
  • Maywood Illinois 60153 United States
  • Roudebush VA Medical Center
  • Indianapolis Indiana 46202 United States
  • University of Louisville
  • Louisville Kentucky 40202 United States
  • Washington University School of Medicine
  • St. Louis Missouri 63110 United States
  • Coastal Urology Associates
  • Brick New Jersey 08724 United States
  • Manhattan Medical Research
  • New York New York 10016 United States
  • Icahn School of Medicine at Mount Sinai
  • New York New York 10029 United States
  • Urologic Consultants of SE Pennsylvania
  • Bala Cynwyd Pennsylvania 19004 United States
  • University of Pennsylvania
  • Philadelphia Pennsylvania 19104 United States
  • Thomas Jefferson University Hospital
  • Philadelphia Pennsylvania 19107 United States
  • Fox Chase Cancer Center
  • Philadelphia Pennsylvania 19111 United States
  • University of Utah, Huntsman Cancer Institute
  • Salt Lake City Utah 84112 United States

View trial on ClinicalTrials.gov


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