Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorBaptist Health South Florida

About this trial

The purpose of this research study is to test the efficacy of ADT on prostate-specific membrane antigen (PSMA), a marker of prostate cancer, before and after scheduled ADT. Follow up will be 48 months your prostate removal to do a blood test and log if any new or worsening symptoms have occurred as a part of your standard-of-care (SOC).

Eligibility criteria

Qualifiers

Signed informed consent must be obtained prior to participation in the study.

Males aged ≥18 years.

ECOG performance status ≤ 1

Histologically confirmed adenocarcinoma of the prostate in a patient amenable to radical prostatectomy

Disqualifiers

Known allergies, hypersensitivity, or intolerance to 18F-flotufolastat.

Unable to receive androgen deprivation therapy.

Prostate cancer with significant neuroendocrine or other rare variant pathology

Evidence of metastatic disease involving bone, viscera, or lymph nodes superior to the bifurcation of the common iliac arteries on PSMA PET/CT

Trial design

Treatments tested in this trial

  • Leuprolide
  • Degarelix
  • Relugolix
  • Triptorelin
  • Bicalutamide
  • 18-F Flotufolastat PSMA PET
  • Radical prostatectomy

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Baptist Health South Florida

Lead sponsor

Blue Earth Diagnostics

Collaborator