C11-Sodium Acetate PET/CT Imaging for Metastatic Disease in Intermediate-to-high Risk Prostate Adenocarcinoma
Overview
- Phase
- Phase 2
- Intervention
- C11-Sodium Acetate
- Conditions
- Prostate Cancer
- Sponsor
- Phoenix Molecular Imaging
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Tissue Biopsy of metastatic site(s)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Positron emission tomography using carbon-11 acetate (AC-PET) may help find local or distant metastases from prostate cancer. This clinical trial is studying how this imaging test may help influence the choice and extent of initial treatments, and subsequent treatments.
Detailed Description
OBJECTIVES: * Determine the role of positron emission tomography using carbon-11 acetate (AC-PET) in the initial and subsequent management of patients with prostate cancer at intermediate or high risk for recurrence after initial curative therapy. * Compare the value of AC-PET in predicting recurrence of prostate cancer with that of conventional approaches (e.g., pre-operative clinical staging, prostate-specific antigen, Gleason score, prostate and lymph node histology) in these patients.
Investigators
Fabio Almeida MD
Medical Director and Principal Investigator
Phoenix Molecular Imaging
Eligibility Criteria
Inclusion Criteria
- •Male patients will be studied who have prostate cancer:
- •Diagnosed with prostate adenocarcinoma
- •Has completed conventional staging examinations, including histologic evaluation with Gleason score, CT scan of the abdomen and pelvis, and whole-body bone scintigraphy Candidate for curative prostatectomy OR curative radiotherapy OR staging lymphadenectomy prior to surgery
- •Deemed to be at intermediate or high risk for recurrence or metastatic disease after initial curative treatment, as defined by of one of the following:
- •Gleason score \>= 7 or PSA \>= 10
- •Gleason score \< 7 or PSA \<10 ng/mL with positive surgical margins, biopsy proven or suspected regional nodal involvement or conventional imaging showing limited metastatic disease that may be amenable to directed radiotherapy
- •Rising or non-responding PSA
Exclusion Criteria
- •\< 18 years old
- •claustrophobic patients
Arms & Interventions
PET/CT imaging with C11-Sodium Acetate
Intervention: C11-Sodium Acetate
Outcomes
Primary Outcomes
Tissue Biopsy of metastatic site(s)
Time Frame: Assessed within 30 days following AC-PET
Patients will undergo needle biopsy of positive metastatic findings on C11- Acetate PET/CT
Secondary Outcomes
- PSA (prostate specific antigen)(Each 3 - 6 months for 24 months)