Eclipse: Flotufolastat F 18 to Determine Treatment Success Following Prostate Focal Therapy


Condition: Prostate Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07185165

Sponsor: Jonsson Comprehensive Cancer Center

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 90 Years
  • Gender: Male

Inclusion Criteria:

  • Men aged 18-90 at study enrollment
  • History of prostate cancer
  • Men who have had focal therapy (laser, cryotherapy, high-intensity focused ultrasound [HIFU], Tulsa Pro, irreversible electroporation [IRE], brachytherapy) within 6-36 months of enrollment

Exclusion Criteria:

  • Contraindication to flotufolastat F 18 PET CT
  • Contraindication to ultrasound-guided prostate biopsy
  • Patients who are planned to have an x-ray contrast agent or other PET radiotracer < 24 hours prior to the PET scan
  • Patients with castrate levels of testosterone secondary to androgen deprivation therapy
  • Inability to provide written informed consent
  • Known inability to remain still and lie flat for the duration of the PET/CT (about 30 minutes)
  • Any investigational agents within 42 days prior to the day of the first dose
  • Not able to understand and to follow study instructions and requirements. This also includes the inability to complete the study imaging and or biopsy procedures due to any reason (e.g., severe claustrophobia, inability to lie still for the entire imaging time, any condition that precludes raised arms position)

View trial on ClinicalTrials.gov