A Pilot Study of Use of 11C-Choline PET-CT in the Metastatic Evaluation of Patients With Newly Diagnosed High Risk Adenocarcinoma of the Prostate
Overview
- Phase
- Phase 1
- Intervention
- needle biopsy
- Conditions
- Prostate Cancer
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Determination of utility of 11C-Choline in enhancing efficacy of Pet-CT scans
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
RATIONALE: New diagnostic procedures, such as C-11 choline PET-CT scan, may be effective in finding cancer that has spread to the bone and lymph nodes in patients with prostate cancer.
PURPOSE: This clinical trial is studying how well C-11 choline PET-CT scan works in finding metastases in patients with newly diagnosed high-risk prostate cancer.
Detailed Description
OBJECTIVES: Primary * To determine the sensitivity and specificity of PET-CT scan using C-11 choline in detecting bone and lymph node metastases in patients with newly diagnosed high-risk adenocarcinoma of the prostate. Secondary * To perform semi-quantitative analysis of tracer uptake using standard uptake values and qualitative analysis using pure visual analysis. * To develop an algorithm that includes the routine use of C-11 choline PET-CT scan for the staging of patients with prostate cancer at high risk of metastatic disease. * To determine whether the presence of C-11 choline PET-CT scan positivity in these patients is predictive of outcomes, including biochemical relapse-free survival, time to development of clinically apparent metastases, time to local failure, and overall survival. * To obtain tissue specimens from these patients for correlative studies and further evaluation. * To obtain information regarding the feasibility and characteristics of C-11 choline PET-CT scan after androgen suppression. OUTLINE: Patients undergo CT scan of the abdomen and pelvis with IV contrast and a bone scan. Patients also undergo a C-11 choline PET-CT scan\*. In the case of any positive scan, patients undergo a needle biopsy. If the biopsy is negative for metastatic disease or if the biopsy is positive for metastatic disease in a draining lymph node region, patients receive radiotherapy and hormonal (antiandrogen) therapy. If the biopsy is positive for metastatic disease at any other site, patients receive hormonal therapy alone. NOTE: \*The first 10 patients enrolled on the study who have a positive PET-CT scan and positive biopsy undergo a second PET-CT scan at 6 months after the initial PET-CT scan. Patients are followed every 3 months for 1 year and then every 6 months for 1 year.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed adenocarcinoma of the prostate
- •Prior negative prostate biopsy allowed
- •High-risk disease, as defined by one of the following:
- •PSA ≥ 20 ng/mL
- •Gleason score ≥ 8
- •Digital rectal examination revealing ≥ T2c disease (tumor involving more than one half of one lobe of the prostate)
- •Creatinine \< 2.0 mg/dL
- •Able to tolerate PET scan, CT scan, and bone scan
- •Able to tolerate IV and oral contrast
- •Willing to undergo biopsy of positive findings on PET-CT scan, CT scan, or bone scan
Exclusion Criteria
- •Other cancer within the past 5 years (except for nonmelanoma skin cancer)
- •No prior radiotherapy, hormonal therapy, surgery (other than biopsy), or cryotherapy for prostate cancer Prior transurethral resection of the prostate allowed
Arms & Interventions
radiolabeled choline tracer scans
PET-CT scans supplemented with Choline 11 tracer
Intervention: needle biopsy
radiolabeled choline tracer scans
PET-CT scans supplemented with Choline 11 tracer
Intervention: PET-CT scans supplemented with 11C-Choline tracer
Outcomes
Primary Outcomes
Determination of utility of 11C-Choline in enhancing efficacy of Pet-CT scans
Time Frame: Approximately 1 year
To determine the differential usefulness 11C-Choline during PET-CT to enhance diagnostic capability in evaluating metastatic disease.