Status:
COMPLETED
C-11 Choline PET-CT Scan in Finding Metastases in Patients With Newly Diagnosed High-Risk Prostate Cancer
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
30-120 years
Phase:
PHASE1
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 ...
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 adenocarci...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00804245
Start Date
August 1 2008
End Date
August 1 2013
Last Update
July 3 2018
Active Locations (1)
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1
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096