Completed
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
Led by Wake Forest University Health Sciences · Updated on 2018-07-03
18
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Brief Title
C-11 Choline PET-CT Scan in Finding Metastases in Patients With Newly Diagnosed High-Risk Prostate Cancer
Who Can Participate
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
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