This phase II trial tests the effect of adding early time point imaging during the 18F flotufolastat prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) scan and standard of care (SOC) bicalutamide therapy in detecting disease that remains (residual) or that may have spread from where it first started (primary site) to other places in the body (metastatic) in patients with prostate cancer with increasing prostate-specific antigen (PSA) levels after treatment (biochemical recurrence). A PET scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Because tumor cells often take up more glucose than normal cells, the pictures can be used to find tumor cells in the body. CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. A PSMA PET is a PET imaging technique that uses 18F flotufolastat to bind to tumor cells and locate tumor lesions. Bicalutamide, an antiandrogen, lowers the amount of hormone made or used by the body. This may help stop the growth of tumor cells that need hormones to grow. Bicalutamide has also been known to increase PSMA expression on prostate tumor cells. Adding an early time point PSMA PET/CT scan imaging with SOC bicalutamide therapy may increase the expression on prostate tumor cells and improve detection of residual or metastatic lesions in patients with biochemical recurrent prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07593079.
Locations matching your search criteria
United States
Missouri
Saint Louis
Siteman Cancer Center at Washington UniversityStatus: Approved
Contact: Vikas Prasad
Phone: 314-632-2812
PRIMARY OBJECTIVE:
I. To investigate the role of bicalutamide in upregulation of PSMA expression on prostate cancer (PCa) metastases or local residual disease in biochemical recurrence (BCR) therapy patients with low levels of PSA. (Group B only)
SECONDARY OBJECTIVES:
I. To investigate incremental value of adding early time point (first 5 minutes post fluorine F 18 flotufolastat gallium [Posluma] injection) images on lesion detection as compared to late (60 minutes post Posluma injection) standard of care imaging. (Group A and B)
II. To investigate the correlation between PSA response and PROSTest (a blood based liquid biopsy panel evaluating the expression of 27 prostate cancer associated genes) results in PCa patients when treated with radiation therapy. (Group A and B)
III. To investigate the role of PSA kinetics in predicting detection of lesions on PSMA PET/CT before and after bicalutamide. (Group A and B)
IV. To investigate the correlation between PROSTest and PSMA PET/CT results pre- and post-bicalutamide. (Group B only)
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP A (PET1): Patients receive furosemide intravenously (IV) followed by F-18 flotufolastat IV and undergo SOC PSMA PET/CT immediately after injection and then again in 60 minutes. Starting the day after PET1, patients receive SOC bicalutamide orally (PO) for a minimum of 14 days in the absence of disease progression or unacceptable toxicity. Starting after day 14, patients may undergo radiation therapy per SOC. Additionally, patients undergo blood sample collection throughout the study.
GROUP B: Patients receive furosemide IV followed by F-18 flotufolastat IV and undergo SOC PSMA PET/CT immediately after injection, in 60 minutes at baseline and then again on day 14. Starting the day after PET1, patients receive SOC bicalutamide PO for a minimum of 14 days in the absence of disease progression or unacceptable toxicity. Starting after day 14, patients may undergo radiation therapy per SOC. Additionally, patients undergo blood sample collection throughout the study.
After completion of study intervention, patients are followed up for up to 90 days post-PET1.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorVikas Prasad
