Carbon-11 Acetate PET / CT Imaging in Evaluating Response to Radium Ra 223 Dichloride Therapy in Patients with Hormone-Resistant Metastatic Prostate Cancer

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Active
Contact: Daniel Alexander Pryma
Phone: 215-349-5272
Email: PennCancerTrials@emergingmed.com

Trial Objectives and Outline

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 Phase & Type

Trial Phase

No phase specified

Trial Type

Diagnostic

Lead Organization

Lead Organization
University of Pennsylvania / Abramson Cancer Center

Principal Investigator
Daniel Alexander Pryma

Trial IDs

Primary ID UPCC 02816
Secondary IDs NCI-2016-00612
Clinicaltrials.gov ID NCT02715583