68ga-PSMA-11 patients with newly diagnosed and recurrent prostate cancer (Firefly).

Abstract

TPS189 Background: A primary challenge facing oncologists is the accurate identification of the source of the rising PSA in the recurrent disease setting and the failure of proper staging at the time of initial therapy. Current imaging modalities perform poorly in this regard. PSMA imaging is FDA approved but reimbursement remains a considerable issue for most patients. Methods: This is a phase II expanded access intermediate sized clinical trial using 68Ga-PSMA-11 (Telix Pharma cold kit) under our own Investigational New Drug (IND) with the FDA. Two cohorts are utilized, recurrent disease with a PSA > 0.2 or > 2.0 post-radiation, and newly diagnosed high risk localized disease and/or oligo-metastatic patients as assessed by conventional imaging. 300 patients will be allowed to enroll and 63 are enrolled to date. Patients will be injected with 1.8–2.2 MBq/kg body weight with 68Ga-PSMA-11 (per EANM guidelines). The lower and upper limits of the dose are set to 3 to 7 mCi respectively. Primary Objective(s): Utilize 68Ga-PSMA-11 PET images to define uptake location for localization of prostate cancer metastatic sites in patients prior to initial therapy and to utilize 68Ga-PSMA-11 PET images to define uptake location for localization of prostate cancer including both local recurrences and metastatic sites in patients with recurrent disease after initial therapy. Secondary Objectives: To assess the therapeutic consequences of 68Ga-PSMA-11 PET/CT imaging in prostate cancer patients with and without prior treatment. As such the planned therapies after the PSMA scan will be annotated and recorded. In addition, we aim to determine the number of patients with metastatic disease prior to initial therapy that was not diagnosed with conventional imaging and we aim to determine the locations of recurrent disease for those patients who have demonstrated PSA recurrence after curative therapy. Percentage of positive scans will be assessed for PSA values 0.2-0.5 ng/mL, > 0.5-1.0 ng/mL, > 1.0- > 2.0 ng/mL, and > 2 ng/mL. Results will be summarized descriptively with 95% confidence intervals. Localization of all lesions will be performed with regard to lymph nodes (pelvic versus non-pelvis), bones (by location), and other (by site). Treatment planning will be captured and quantified by radiation, surgery, hormonal therapy (type and duration), and/or observation at the time of the initial clinical visit after the PSMA scan and 6 months later. This trial is open and recruiting patients. Data analysis has not been performed. Clinical trial information: NCT04854369.