Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01054079|
Recruitment Status : Completed
First Posted : January 22, 2010
Results First Posted : October 29, 2015
Last Update Posted : May 11, 2018
|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|
|Actual Study 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
Procedure: quality-of-life assessment
Other Name: quality of life assessment
Other: questionnaire administration
Drug: 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.
- Change in Quality of Life (QOL) as Assessed by the Brief Male Sexual Inventory [ Time Frame: Up to 20 weeks ]The Brief Male Sexual Inventory is an 11 question assessment including subscales: sex drive, erections, ejaculation. The scores are totaled to produce an overall score with a range of 1-45, with higher score indicating worse outcomes.
- Change in Hormonal Assessment Scale From Expanded Prostate Cancer Index Composite (EPIC) [ Time Frame: up to 20 weeks ]The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Epic produces two scores, one for function (5 items) and the other for bother (6 items). The response for each item is standardized to a 0 to 100 scale. For both scales, higher scores indicate worse outcomes.
- Change in Functional Assessment of Cancer Therapy-Prostate (FACT-P) [ Time Frame: up to 20 weeks ]The FACT-P is a multidimensional, self-report QoL instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain, as well as a global QoL score. All subscale items are summed to a total. The score range is 0-156. Higher scores represent better quality of life.
- Change in Total and Free Testosterone [ Time Frame: Up to 20 weeks ]The detectable difference is estimated using a paired t-test approach. The lab measure will also be analyzed longitudinally using all measures with a mixed model approach adjusting for individual covariates.
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|