Study of Recurrent Prostate Cancer With Rising Prostate Specific Antigen (PSA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael A. Carducci, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01118741
First received: April 29, 2010
Last updated: May 15, 2014
Last verified: May 2014
Results First Received: December 13, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: Disulfiram

  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
Recruitment dates: 06/04/2010 through 08/01/2011 in medical clinics

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Given the toxic effects of disulfiram when administered within 14 days of ingesting ethanol, participants were required to agree not to drink alcohol during the study and for 14 days after its completion.

Reporting Groups
  Description
Disulfiram Low Dose 250mg Dose First 9 subjects were assigned to the low dose (250mg) arm. These subjects took 250mg daily for 28 days per cycle.
Disulfiram High Dose 500mg Dose After accrual to the low dose was complete,ten subjects were assigned to the high dose (500mg) arm. These subjects took 500mg daily for 28 days per cycle.

Participant Flow:   Overall Study
    Disulfiram Low Dose 250mg Dose     Disulfiram High Dose 500mg Dose  
STARTED     9     10  
COMPLETED     9     10  
NOT COMPLETED     0     0  



  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.
No text entered.

Reporting Groups
  Description
Disulfiram Low Dose 250mg Dose First 9 subjects were assigned to the low dose arm
Disulfiram High Dose 500mg Dose After 9 subjects were enrolled in the low dose arm, the high dose was opened.
Total Total of all reporting groups

Baseline Measures
    Disulfiram Low Dose 250mg Dose     Disulfiram High Dose 500mg Dose     Total  
Number of Participants  
[units: participants]
  9     10     19  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     3     8     11  
>=65 years     6     2     8  
Age  
[units: years]
Mean ± Standard Deviation
  66.6  ± 7.0     62.6  ± 3.4     64.5  ± 5.6  
Gender  
[units: participants]
     
Female     0     0     0  
Male     9     10     19  
Region of Enrollment  
[units: participants]
     
United States     9     10     19  



  Outcome Measures

1.  Primary:   Proportion of Subjects With a Demethylation Response at Each Dose Level   [ Time Frame: 24 months ]

2.  Secondary:   Clinical Response   [ Time Frame: After 6 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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
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  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: Michael Carducci, MD
Organization: Johns Hopkins University
phone: 410-614-3977
e-mail: carducci@jhmi.edu


No publications provided


Responsible Party: Michael A. Carducci, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01118741     History of Changes
Other Study ID Numbers: J0972
Study First Received: April 29, 2010
Results First Received: December 13, 2013
Last Updated: May 15, 2014
Health Authority: United States: Food and Drug Administration