drugset / Trial / NCT02852122

The Role of C-11 Choline PET in Patients With Prostate Cancer

NCT02852122

Completed 54 enrolled Chang Gung Memorial Hospital
NaSingle-groupOpen-labelDiagnostic

Summary

The investigators determine the target number as 54 patients based on the following reasons: (a) The bony metastasis rate for the high risk prostate cancer patients with PSA from 20 to 99.9 ng/ml was 21% (166/767 cases in a systemic review) \[8\]; the estimated sample size would be 47 under the condition of 20% more distant metastasis cases were identified by the PET/MRI scan using the 90% power, significance level of 0.05 and one sample proportion test. Assuming a dropout rate of 10%, the final ideal sample size is 52 patients. (b) The newly diagnostic number for the high risk prostate cancer patients in our hospital annually is \~70, about 6 patients a month. It is clinically feasible to recruit 3 patients a month until 18 months since the study begin. The study could be completed in 2 years with 54 cases

Timeline

Start
2015-01
Primary completion
2016-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Subject C11-Choline Diagnostic / imaging agent

Indications