C-11 Choline PET-CT Scan in Finding Metastases in Patients With Newly Diagnosed High-Risk Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00804245|
Recruitment Status : Completed
First Posted : December 8, 2008
Last Update Posted : July 3, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: needle biopsy Drug: PET-CT scans supplemented with 11C-Choline tracer||Phase 1|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||August 2013|
Experimental: radiolabeled choline tracer scans
PET-CT scans supplemented with Choline 11 tracer
Procedure: needle biopsy
Biopsy of positive findings found on CT scan
Drug: PET-CT scans supplemented with 11C-Choline tracer
Use of 11C-Choline tracer to enhance diagnostic utility of 11C-Choline tracer
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00804245
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||Pradeep Garg, PhD||Wake Forest University Health Sciences|