Continuing Low Dose Aspirin Before Prostate Biopsy
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Objectives: To determine whether TRUS-guided prostate biopsy performed in patients continuing
low-dose aspirin (LDA) is associated with a greater incidence, duration, and severity of
bleeding complications.
Eligibility: Men over 40-year-old with an elevated serum prostate-specific antigen level
and/or abnormal digital rectal examination findings are candidates for PB.
Design of trial Prospective Randomized Trial Study treatment: Continuing low-Dose aspirin
before transrectal prostate biopsy Primary endpoint: The incidence, duration, and severity of
bleeding complications Statistical analysis and sample size estimation: Fisher's exact test
or chi-square test will be used to explore the differences between two groups for categorical
variables, and Student t-test will be used for continuous variables. Under the assumption of
a difference of 25% of bleeding complications in each group, with α=0.05 and power=0.80, 60
subject are needed in each arm. Assuming the drop-out rate to be 20%, the targeted recruit
number is 150 in total.