Trial Information

Evaluation of [18F] Fluorocholine PET/CT for Detection of Regional Lymph Node Metastases From Prostate Cancer

The purpose of this prospective trail is to improve the staging of patients with prostate
cancer. The investigators focus on the group of patients with a newly diagnosed prostate
cancer, and specifically the ones who have an intermediate and high risk of disseminated
prostate cancer.

The aim is to improve staging by replacing the traditional invasive method, the
lymphadenectomy, which has a rather low sensitivity by a non-invasive method, 18F-choline
PET/CT which has a presumably superior sensitivity.

The treatment of patients with prostate cancer relies on the stage of the disease. Patients
with disseminated prostate cancer are incurable and are treated with palliatively. In
contrast, patients with localized prostate cancer are offered curative therapy. Hence, the
stage of prostate cancer is crucial for the choice of treatment.

The potential benefits are

- The patients avoid the surgical trauma including complications and convalescents
period.

- The accuracy of the prostate cancer staging is improved, the potential of which is
better survival.

The patients are 18F-choline PET/CT scanned prior to their lymphadenectomy, the results of
the 18F-choline PET/CT are blinded for the surgeon. The endpoint of the trail is the
comparison of 18F-choline PET/CT and the histopathological investigation of the regional
lymph nodes of prostate.

Assuming a prevalence of metastasised prostate cancer of 20% and a true (unknown)
sensitivity of FCH PET/CT of 95%, 205 patients are sufficient to show that the sensitivity
of the FCH PET/CT is greater than 80% with a power of 80% at significance level 5%. The size
of the confidence interval for specificity of FCH PET/CT is expected to become reasonable
small. In opposition to lymphadenectomy, FCH PET/CT results may point to metastases in
neighbouring regions which gives an additional benefit to FCH PET/CT justifying a test level
for sensitivity of 80%."

Accordingly 205 patients will be included over 2½ years. The first patients have been
included in January 2008. Interim analyses will be done after 25, 50 and 100 patients.