Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer
|Adenocarcinoma of the Prostate Recurrent Prostate Cancer||Other: laboratory biomarker analysis Procedure: quality-of-life assessment Other: questionnaire administration Drug: cinacalcet hydrochloride||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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.
|Study Start Date:||September 2011|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|