NCT01054079

Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well cinacalcet hydrochloride works in treating men with recurrent prostate cancer. Cinacalcet hydrochloride may be effective in lowering prostate-specific antigen (PSA) levels in patients with recurrent prostate cancer that has not responded to previous treatment

Detailed description

PRIMARY OBJECTIVES: 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. OUTLINE: 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.

Conditions

• Adenocarcinoma of the Prostate
• Recurrent Prostate Cancer

Interventions

Type	Name	Description
OTHER	laboratory biomarker analysis	Correlative study
PROCEDURE	quality-of-life assessment	Ancillary study
OTHER	questionnaire administration	Ancillary study
DRUG	cinacalcet hydrochloride	Given PO

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2010-01-22
• Last updated: 2018-07-05
• Results posted: 2015-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study