Overview

Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer

Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
0
Participant gender:
Male
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Comprehensive Cancer Center of Wake Forest University
Wake Forest University Health Sciences
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cinacalcet
Cinacalcet Hydrochloride
Criteria
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")

- 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)