Carbon-11 Acetate PET / CT Imaging in Evaluating Response to Radium Ra 223 Dichloride Therapy in Patients with Hormone-Resistant Metastatic Prostate Cancer
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.
- History of biopsy proven or clinically documented castrate resistant prostate cancer which is metastatic to bone as assessed by medical record review
- Patients selected for Ra-223 dichloride therapy for treatment of bone metastasis by their treating physician
- Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures
- Only individuals who can understand and give informed consent will be eligible to participate in this study
- Not on current androgen deprivation therapy or plan for withdrawal of androgen deprivation therapy
- Cytotoxic chemotherapy within 4 weeks prior to study enrollment
- Systemic radioisotope therapy within 24 weeks prior to study enrollment
- Eminent or established cord compression as assessed by medical record review
- History of hemibody external radiotherapy as assessed by medical record review
- Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
- Serious or unstable medical or psychological comorbidities that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the study
- Documented visceral metastases or current lymphadenopathy > 3 cm by standard imaging (e.g. magnetic resonance imaging [MRI], CT, ultrasound, fludeoxyglucose [FDG] PET/CT)
- Individuals who are considered to be mentally disabled will not be recruited for this study
- Women, children, fetuses, neonates, or prisoners are not included in this research study
Locations & Contacts
Contact: Daniel Alexander Pryma
Trial Objectives and Outline
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.
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.
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 Phase & Type
No phase specified
University of Pennsylvania / Abramson Cancer Center
Daniel Alexander Pryma
Secondary IDs NCI-2016-00612
Clinicaltrials.gov ID NCT02715583