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

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Comprehensive Cancer Center of Wake Forest University; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Choline

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