This pilot clinical trial studies carbon-11 acetate positron emission tomography/computed tomography (PET/CT) in evaluating response to radium Ra 223 dichloride therapy in patients with prostate cancer that has not responded to previous treatment with hormones and that has spread to the bones. Carbon-11 acetate is a specialized radioactive drug that is used to allow imaging of tissue using a PET/CT scanner which is specialized to detect a small radioactive signal. Carbon-11 acetate is used to evaluate cell growth and how fast cells replicate. The amount of carbon-11 acetate that is taken up by cancer cells before and after radium Ra 223 therapy may help to understand whether patients with hormone-resistant metastatic prostate cancer are responding to treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02715583.
PRIMARY OBJECTIVES:
I. Estimate the fold change in maximum standardized uptake value (SUVmax) of selected index lesions and the sum of SUVmax over the most carbon-11 acetate (11C-acetate) avid lesions, up to five, measured at pre and post radium (Ra)- 223 dichloride therapy.
SECONDARY OBJECTIVES:
II. Estimate the fold change in SUVmax of a selected index lesion and the sum of SUVmax over the most 11C-acetate avid lesions, up to five, measured at 10 weeks (+/- 3 week) vs. quantitative technetium Tc-99m medronate (99mTc-MDP) bone scans.
III. Assess baseline SUVmax for an index lesion and the sum of SUVmax over the most 11C-acetate avid lesions, up to five, as a predictor of symptom relief, time to progression (TTP), skeletal related events (SRE) or changes in tumor and bone metabolism markers.
OUTLINE:
Patients undergo a technetium Tc-99m medronate bone scan as part of standard clinical care at baseline and a second research technetium Tc-99m medronate bone scan after 2 courses (approximately 10 weeks) of radium Ra 223 dichloride therapy. Patients also receive carbon-11 acetate intravenously (IV) and undergo PET/CT at baseline and after 2 courses of radium Ra 223 dichloride therapy.
After completion of study treatment, patients are followed up periodically.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorDaniel Alexander Pryma
