C-11 Choline PET-CT Scan in Finding Metastases in Patients With Newly Diagnosed High-Risk Prostate Cancer

Completed · Phase 1

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00804245

Run by

Wake Forest University Health Sciences

People needed

18

Starts

2008-08-01

Expected to finish

2013-08-01

Last updated by the study team

2018-07-03

Who can join

Age: 30 and older, up to 120. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Wake Forest University Comprehensive Cancer Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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