Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01054079|
Recruitment Status : Unknown
Verified September 2015 by Wake Forest University Health Sciences.
Recruitment status was: Active, not recruiting
First Posted : January 22, 2010
Results First Posted : October 29, 2015
Last Update Posted : October 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Prostate Recurrent Prostate Cancer||Other: laboratory biomarker analysis Procedure: quality-of-life assessment Other: questionnaire administration Drug: cinacalcet hydrochloride||Phase 2|
I. To test the hypothesis that once-daily treatment with 30 mg of cinacalcet hydrochloride (Sensipar) will reduce the rate of rise of serum prostate-specific antigen (PSA) compared to pre-treatment PSA values in subjects with biochemically recurrent prostate cancer after failed definitive local therapy.
Patients receive cinacalcet hydrochloride orally (PO) once daily (QD) for 20 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial to Assess the Effect of Cinacalcet Hydrochloride on PSA Levels in Patients With Biochemically Recurrent Prostate Cancer After Failed Definitive Local Therapy|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||August 2014|
Experimental: Treatment (cinacalcet hydrochloride)
Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
Correlative studyProcedure: quality-of-life assessment
Other Name: quality of life assessmentOther: questionnaire administration
Ancillary studyDrug: cinacalcet hydrochloride
- Rate of Rise of Serum PSA [ Time Frame: 24 weeks ]The difference of post treatment and pre-enrollment PSA.For those with multiple PSA measures post we use the median of those measures to estimate the participant's post PSA level.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01054079
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||K.C. Balaji, MD||Wake Forest University Health Sciences|