Adenocarcinoma of the Prostate Clinical Trial
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
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
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.
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