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Trial Outcomes & Findings for Randomized Trial of Ciprofloxacin Versus Observation for Men With Elevated Prostate Specific Antigen (PSA) (NCT NCT00840294)

NCT ID: NCT00840294

Last Updated: 2014-08-01

Results Overview

To assess the impact of ciprofloxacin on the change in PSA from baseline/randomization to prostate biopsy which occurs 21-45 days after randomization. Due to the skewness of the data, the log transformation was used and the outcome used was the log(PSA level post-treatment, at time of biopsy) - log(PSA level baseline).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

85 participants

Primary outcome timeframe

At baseline and 21-45 days after randomization

Results posted on

2014-08-01

Participant Flow

Participant milestones

Participant milestones
Measure
Observation
Observation only for 2 weeks
Antibiotic
Ciprofloxacin 500 mg twice daily for 2 weeks
Overall Study
STARTED
42
43
Overall Study
COMPLETED
39
38
Overall Study
NOT COMPLETED
3
5

Reasons for withdrawal

Reasons for withdrawal
Measure
Observation
Observation only for 2 weeks
Antibiotic
Ciprofloxacin 500 mg twice daily for 2 weeks
Overall Study
Withdrawal by Subject
2
1
Overall Study
Protocol Violation
1
3
Overall Study
Illness
0
1

Baseline Characteristics

Randomized Trial of Ciprofloxacin Versus Observation for Men With Elevated Prostate Specific Antigen (PSA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Observation
n=39 Participants
Observation only for 2 weeks
Antibiotic
n=38 Participants
Ciprofloxacin 500 mg twice daily for 2 weeks
Total
n=77 Participants
Total of all reporting groups
Age, Continuous
61.7 years
n=5 Participants
60.4 years
n=7 Participants
60.6 years
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Male
39 Participants
n=5 Participants
38 Participants
n=7 Participants
77 Participants
n=5 Participants
Race/Ethnicity, Customized
Caucasian
23 participants
n=5 Participants
26 participants
n=7 Participants
49 participants
n=5 Participants
Race/Ethnicity, Customized
African-American
12 participants
n=5 Participants
10 participants
n=7 Participants
22 participants
n=5 Participants
Race/Ethnicity, Customized
Other
4 participants
n=5 Participants
2 participants
n=7 Participants
6 participants
n=5 Participants
Region of Enrollment
United States
39 participants
n=5 Participants
38 participants
n=7 Participants
77 participants
n=5 Participants
PSA level
6.5 ng/mL
n=5 Participants
7.6 ng/mL
n=7 Participants
7.0 ng/mL
n=5 Participants

PRIMARY outcome

Timeframe: At baseline and 21-45 days after randomization

Population: Subjects with complete data are included

To assess the impact of ciprofloxacin on the change in PSA from baseline/randomization to prostate biopsy which occurs 21-45 days after randomization. Due to the skewness of the data, the log transformation was used and the outcome used was the log(PSA level post-treatment, at time of biopsy) - log(PSA level baseline).

Outcome measures

Outcome measures
Measure
Observation
n=39 Participants
Observation only for 2 weeks
Antibiotic
n=38 Participants
Ciprofloxacin 500 mg twice daily for 2 weeks
Change in PSA Level From Baseline
-0.08 log ng/mL
Standard Deviation 0.39
0.005 log ng/mL
Standard Deviation 0.42

SECONDARY outcome

Timeframe: Within 24 hours of biopsy

Population: Subjects with complete data are included.

To assess the impact of ciprofloxacin on the overall infectious complication rate following prostate biopsy

Outcome measures

Outcome measures
Measure
Observation
n=39 Participants
Observation only for 2 weeks
Antibiotic
n=38 Participants
Ciprofloxacin 500 mg twice daily for 2 weeks
Overall Infectious Complication Rate Following Prostate Biopsy
0 percentage of participants
Interval 0.0 to 9.0
2.6 percentage of participants
Interval 0.07 to 13.8

Adverse Events

Observation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Antibiotic

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Observation
n=39 participants at risk
Observation only for 2 weeks
Antibiotic
n=38 participants at risk
Ciprofloxacin 500 mg twice daily for 2 weeks
Infections and infestations
Sepsis
0.00%
0/39 • during the 2 weeks of study treatment
Subjects with complete data are included.
2.6%
1/38 • during the 2 weeks of study treatment
Subjects with complete data are included.

Other adverse events

Adverse event data not reported

Additional Information

Scott Eggener

University of Chicago

Phone: (773) 702-5195

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place