This clinical trial studies how well an investigational scan called low-count quantitative single-photon emission computed tomography (LC-QSPECT) works in imaging patients with castration-resistant prostate cancer that spread from where it first started (primary site) to the bones (bone metastases) and are receiving treatment with Xofigo. Xofigo (also known as radium-223 dichloride) is a radioactive treatment that is approved by the Food and Drug Administration to treat bone metastases in people with prostate cancer, because it is able to target areas of increased bone turnover (which is what bone metastases are). Although Xofigo has been shown to be effective, it can be difficult to use standard imaging scans to find out where it is collecting in the body. The LC-QSPECT scan uses X-rays to create a picture of the bones and soft tissues in the body and single-photon emission computed tomography imaging using the Xofigo that has been injected as standard treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07221825.
Locations matching your search criteria
United States
Missouri
Saint Louis
Siteman Cancer Center at Washington UniversityStatus: Approved
Contact: Abhinav Jha
Phone: 314-273-2655
PRIMARY OBJECTIVE:
I. To prospectively determine the performance of LC-QSPECT imaging on the task of quantifying isotope uptake in lesions and dose-limiting organs post administration of radium Ra 223 dichloride ([223Ra]RaCl2).
SECONDARY OBJECTIVES:
I. To determine the safety and tolerability of the LC-QSPECT procedure in patients with prostate cancer.
II. To determine the feasibility of performing LC-QSPECT.
III. To determine the correlation between activity distributions and clinical outcomes.
IV. To assess the impact of whether the treatment plan for a patient is altered by the use of the LC-QSPECT imaging.
V. To evaluate the performance of the LC-QSPECT procedure using a no-gold-standard evaluation technique.
OUTLINE:
Patients undergo LC-QSPECT scan over 45-60 minutes between 6 and 36 hours after receiving radium Ra 223 dichloride (Xofigo) during cycles 1 and 3 of standard treatment. Patients also undergo additional computed tomography (CT) scans, bone scans, and collection of blood and urine samples throughout the study. Patients may also undergo an optional bone biopsy on study.
After completion of study intervention, patients are followed monthly until 3 years after start of Xofigo treatment.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorAbhinav Jha
