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

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
adenocarcinoma of the prostate.

Secondary

- 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.

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