This phase I trial examines PARP-1 expression with 18F-fluorthanatrace positron emission tomography (PET)/computed tomography (CT) in patients with prostate cancer that has spread to other places in the body (metastatic). PARP-1, also called poly (ADP-ribose) polymerase-1, is an enzyme involved in many functions of the cell, including the repair of DNA damage. DNA damage may be caused by normal cell activity, UV light, some anticancer drugs, and radiation used to treat cancer. Inhibitors of PARP-1 are studied in the treatment of cancer. 18F-fluorthanatrace is a radioactive tracer, a type of imaging drug that is injected into the body to see how it is taken up in sites of prostate cancer using an imaging procedure called PET/CT. This trial may help test whether 18F-fluorthanatrace can image PARP-1 activity in metastatic prostate cancer and whether the imaging results can be compared with clinical response to treatment with the PARP inhibitor or other treatments for prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05242744.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer CenterStatus: Active
Contact: Neil Kanth Taunk
Phone: 267-593-9059
PRIMARY OBJECTIVE:
I. To establish effect size of change in fluorthanatrace (FTT) uptake before and after systemic therapy in men with prostate cancer metastasis using [18F]fluorthanatrace ([18F]FTT).
SECONDARY OBJECTIVES:
I. To evaluate PARP-1 expression in prostate cancer using measures of uptake of [18F]FTT before and after PARPi and/or androgen deprivation therapy and/or chemotherapy.
II. To correlate [18F]FTT uptake measures with PARP-1 immunohistochemistry (IHC) expression in the tissue specimen, when available.
III. To correlate [18F]FTT uptake measures with PARP-1 [125I]KX1 autoradiography expression in the tissue specimen, when available.
IV. To determine whether baseline and/or pre-/post-treatment changes in [18F]FTT uptake predict clinical response as measured by progression-free survival (PFS) and anatomic criteria.
OUTLINE:
Patients receive fluorine F 18 fluorthanatrace intravenously (IV) and undergo PET/CT prior to starting PARP inhibitor therapy, antiandrogen therapy (ADT), and/or chemotherapy. Patients may receive additional F 18 fluorthanatrace IV and undergo PET/CT 1-21 days after the start of PARP inhibitor therapy regimen, ADT, and/or chemotherapy.
After completion of study treatment, patients are followed up at 24 hours.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorNeil Kanth Taunk
