Carbon-11 Acetate PET / CT Imaging in Evaluating Response to Radium Ra 223 Dichloride Therapy in Patients with Hormone-Resistant Metastatic Prostate Cancer
- 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
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 Phase NA
Trial Type Diagnostic
University of Pennsylvania / Abramson Cancer Center
Daniel Alexander Pryma
- Primary ID UPCC 02816
- Secondary IDs NCI-2016-00612
- Clinicaltrials.gov ID NCT02715583