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

This study has been terminated.
(Combination of futility analysis and poor accrual)
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00840294
First received: February 9, 2009
Last updated: July 7, 2014
Last verified: July 2014
Results First Received: July 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Elevated Prostate Specific Antigen
Intervention: Drug: Ciprofloxacin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Observation Observation only for 2 weeks
Antibiotic Ciprofloxacin 500 mg twice daily for 2 weeks

Participant Flow:   Overall Study
    Observation   Antibiotic
STARTED   42   43 
COMPLETED   39 [1]   38 [1] 
NOT COMPLETED   3   5 
Withdrawal by Subject                2                1 
Protocol Violation                1                3 
Illness                0                1 
[1] These are the subjects included in the baseline, outcomes, and adverse events tables



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects with complete data are included

Reporting Groups
  Description
Observation Observation only for 2 weeks
Antibiotic Ciprofloxacin 500 mg twice daily for 2 weeks
Total Total of all reporting groups

Baseline Measures
   Observation   Antibiotic   Total 
Overall Participants Analyzed 
[Units: Participants]
 39   38   77 
Age 
[Units: Years]
Mean (Inter-Quartile Range)
 61.7 
 (55.5 to 66.7) 
 60.4 
 (53.1 to 66.6) 
 60.6 
 (53.1 to 66.7) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   39   38   77 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   23   26   49 
African-American   12   10   22 
Other   4   2   6 
Region of Enrollment 
[Units: Participants]
     
United States   39   38   77 
PSA level 
[Units: ng/mL]
Mean (Full Range)
 6.5 
 (2.4 to 17.4) 
 7.6 
 (3.1 to 45.7) 
 7.0 
 (2.4 to 45.7) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in PSA Level From Baseline   [ Time Frame: At baseline and 21-45 days after randomization ]

2.  Secondary:   Overall Infectious Complication Rate Following Prostate Biopsy   [ Time Frame: Within 24 hours of biopsy ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination due to poor accrual and interim futility analysis.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Scott Eggener
Organization: University of Chicago
phone: (773) 702-5195
e-mail: seggener@surgery.bsd.uchicago.edu



Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00840294     History of Changes
Other Study ID Numbers: 16368B
Study First Received: February 9, 2009
Results First Received: July 7, 2014
Last Updated: July 7, 2014