[18F]Fluciclovine Companion Imaging Study to Radium-223 and Radiotherapy in Hormone-Naive Men With Oligometastatic Prostate Cancer to Bone (RROPE) Study


Condition: Metastatic Prostate Carcinoma, Prostate Carcinoma Metastatic in the Bone, Stage IV Prostate Cancer

Intervention:

  • Procedure: Computed Tomography
  • Drug: Fluciclovine F18
  • Procedure: Positron Emission Tomography

Purpose: This trial studies how well fluciclovine 18F PET/CT imaging works in assessing hormone-naive men with prostate cancer that has spread to the bone. Fluciclovine 18F is a radioactive drug used to measure tumor growth. PET/CT uses x-rays to take pictures inside the body. Comparing results of fluciclovine 18F PET/CT imaging may help doctors predict a patient's response to treatment and help plan the best treatment.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03707184

Sponsor: University of Utah

Primary Outcome Measures:

  • Measure: Mean standardized uptake value (SUVmean)
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: Maximum standardized uptake value (SUVmax)
  • Time Frame: Up to 2 years
  • Safety Issue:
  • Measure: Lesion uptake of 18F fluciclovine
  • Time Frame: Up to 6 months
  • Safety Issue:
  • Measure: Time to biochemical failure
  • Time Frame: Up to 2 years
  • Safety Issue:

Estimated Enrollment: 15

Study Start Date: September 18, 2018

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Enrollment on IRB #102312 (A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naive Men with Oligometastatic Prostate Cancer to Bone).
  • Patients must document their willingness to be followed for up to 24 months after recruitment by signing informed consent documenting their agreement to allow access to the data obtained on IRB #102312 and information and data entered into a research database.
  • All patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines.

Exclusion Criteria:

  • Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator?s discretion.
  • Patients who require monitored anesthesia for PET scanning.
  • Patients who are too claustrophobic to undergo PET scanning.

Contact:

  • Paige Nielsen
  • 801-585-5942

Location:

  • Huntsman Cancer Institute/University of Utah
  • Salt Lake City Utah 84112 United States

View trial on ClinicalTrials.gov


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