Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer

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.

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)