Trial Information

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

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.