Trial Outcomes & Findings for Impact of Antibiotic Treatment on Prostate-Specific Antigen (PSA) Variability (NCT NCT00596453)

Last Updated: 2017-01-23

Results Overview

We took 4 Prostate Specific Antigen (PSA, ng/mL) measurements per participant. The first PSA test was performed at enrollment. The second PSA test was performed 7 days (+/-3 days) later. Then the participants took the Placebo or Cipro for 14 days. The participants returned for their 3rd PSA test upon completion of the Placebo or Cipro. The final PSA test was performed 7 days (+/-3 days) after the 3rd test. We planned to compare the differences between the first two PSA tests and the last two PSA tests in the Placebo vs Cipro groups.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

31 participants

Primary outcome timeframe

1 month post enrollment

Results posted on

2017-01-23

Participant Flow

3 participants were enrolled but were removed prior to arm/group assignment. One participant was not eligible for the study and the other two participants changed their minds about being part of the research study.

Participant milestones

Participant milestones
Measure	Placebo Placebo: Placebo twice a day for 14 days	Ciprofloxacin Hydrochloride Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
Overall Study STARTED	13	15
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Antibiotic Treatment on Prostate-Specific Antigen (PSA) Variability

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=13 Participants Placebo: Placebo twice a day for 14 days	Ciprofloxacin Hydrochloride n=15 Participants Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=99 Participants	8 Participants n=107 Participants	18 Participants n=206 Participants
Age, Categorical >=65 years	3 Participants n=99 Participants	7 Participants n=107 Participants	10 Participants n=206 Participants
Age, Continuous	58.46 years n=99 Participants	62.73 years n=107 Participants	60.75 years n=206 Participants
Gender Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Gender Male	13 Participants n=99 Participants	15 Participants n=107 Participants	28 Participants n=206 Participants
Region of Enrollment United States	13 participants n=99 Participants	15 participants n=107 Participants	28 participants n=206 Participants

PRIMARY outcome

Timeframe: 1 month post enrollment

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Placebo: Placebo twice a day for 14 days	Ciprofloxacin Hydrochloride n=15 Participants Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
PSA Levels (Change in PSA Levels With and Without Antibiotics Therapy)	1.23 ng/mL Standard Deviation 0.6	0.52 ng/mL Standard Deviation 0.59

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ciprofloxacin Hydrochloride

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=13 participants at risk Placebo: Placebo twice a day for 14 days	Ciprofloxacin Hydrochloride n=15 participants at risk Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
Gastrointestinal disorders Diarrhea	7.7% 1/13 • Number of events 2	6.7% 1/15 • Number of events 4

Additional Information

Misop Han, M.D.

Johns Hopkins Medical Institutions

Phone: 410-502-7454

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place