Overview

This trial is active, not recruiting.

Conditions adenocarcinoma of the prostate, recurrent prostate cancer
Treatments laboratory biomarker analysis, quality-of-life assessment, questionnaire administration, cinacalcet hydrochloride
Phase phase 2
Sponsor Comprehensive Cancer Center of Wake Forest University
Collaborator National Cancer Institute (NCI)
Start date September 2011
End date August 2014
Trial size 20 participants
Trial identifier NCT01054079, CCCWFU 98309, NCI-2009-01514

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.
laboratory biomarker analysis
Correlative study
quality-of-life assessment quality of life assessment
Ancillary study
questionnaire administration
Ancillary study
cinacalcet hydrochloride Mimpara
Given PO

Primary Outcomes

Measure
Rate of rise of serum PSA
time frame: 24 weeks

Secondary Outcomes

Measure
Change in total and free testosterone
time frame: 24 weeks
Change in quality of life (QOL) as assessed by the Brief Male Sexual Inventory, Hormonal Assessment Scale from Expanded Prostate Cancer Index Composite (EPIC), and Functional Assessment of Cancer Therapy-Prostate (FACT-P)
time frame: 24 weeks

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate For patients who have recurrent disease following surgery as first line therapy ("surgical failures"), the PSA requirement is 0.2 ng/ml or above; for patients who have recurrent disease following radiation as first line therapy, the eligibility follows the "Phoenix criteria", that is, a rise of 2 ng/mL over the PSA nadir Eastern Cooperative Oncology Group (ECOG) performance status =< 2 Granulocytes >= 1000/uL Serum creatinine =< 2.0 mg/dl Total serum calcium > 9.0 and < 10.5 mg/dl Total bilirubin =< 2.0 mg/dl Platelet count >=100,000/uL Hemoglobin (Hgb) >= 9 g/dL Total testosterone >= 50 ng/dL Ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative) Exclusion Criteria: Serious medical illness which would limit survival to less than 3 months Active, uncontrolled bacterial, viral or fungal infection Hemorrhagic disorder Any radiographic evidence of metastatic disease including positive bone scan or computed tomography (CT) abdomen/pelvis History of hypocalcemia or seizure disorder Patients with known hypersensitivity to any of the components of cinacalcet (cinacalcet hydrochloride)

Additional Information

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
Principal investigator K.C. Balaji, MD
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. SECONDARY OBJECTIVES: 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. 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Comprehensive Cancer Center of Wake Forest University.
Location data was received from the National Cancer Institute and was last updated in June 2016.