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
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.
I. To assess the effects of cinacalcet hydrochloride on serum calcium, parathyroid hormone
(PTH), total and free testosterone levels in these patients.
II. To assess the effects of cinacalcet hydrochloride on sexual functioning and quality of
life in these patients.
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of rise of serum PSA
For each participant, PSA doubling time (DT) before and after enrollment will be estimated by linear regression. Median PSADT before enrollment will be compared to that after enrollment using a Wilcoxon rank sum test. We will analyze the on-study PSA measures longitudinally using all measures with a mixed model approach adjusting for individual covariates (e.g., age, stage of cancer, time since diagnosis). A further model that we will fit includes baseline PSA as a covariate.
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Wake Forest University Health Sciences||Winston-Salem, North Carolina 27157|