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;   Endpoint Classification: Efficacy Study;   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  
Number of Participants  
[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
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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


No publications provided


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
Health Authority: United States: Institutional Review Board