Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01054079
First received: January 21, 2010
Last updated: September 29, 2015
Last verified: September 2015
Results First Received: August 14, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Interventions: Other: laboratory biomarker analysis
Procedure: quality-of-life assessment
Other: questionnaire administration
Drug: cinacalcet hydrochloride

  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
Treatment (Cinacalcet Hydrochloride)

Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Correlative study

quality-of-life assessment: Ancillary study

questionnaire administration: Ancillary study

cinacalcet hydrochloride: Given PO


Participant Flow:   Overall Study
    Treatment (Cinacalcet Hydrochloride)  
STARTED     20  
# Recieved Proper PSA Testing     10  
COMPLETED     20 [1]
NOT COMPLETED     0  
[1] while all 20 patients received at least some of the intervention, some did not get proper PSA tests.



  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
Treatment (Cinacalcet Hydrochloride)

Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Correlative study

quality-of-life assessment: Ancillary study

questionnaire administration: Ancillary study

cinacalcet hydrochloride: Given PO


Baseline Measures
    Treatment (Cinacalcet Hydrochloride)  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     12  
>=65 years     8  
Age  
[units: years]
Mean (Standard Deviation)
  66.6  (7.1)  
Gender  
[units: participants]
 
Female     0  
Male     20  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures

1.  Primary:   Rate of Rise of Serum PSA   [ Time Frame: 24 weeks ]


  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: Dr. K.C. Balaji
Organization: Comprehensive Cancer Center of Wake Forest University
phone: 336-618-2272
e-mail: kbalaji@wakehealth.edu


No publications provided


Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01054079     History of Changes
Other Study ID Numbers: CCCWFU 98309
NCI-2009-01514 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: January 21, 2010
Results First Received: August 14, 2015
Last Updated: September 29, 2015
Health Authority: United States: Institutional Review Board