Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer

Completed · Phase 2

Conditions studied: Adenocarcinoma of the Prostate, Recurrent Prostate Cancer

In brief

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

Key facts

Study ID

NCT01054079

Run by

Wake Forest University Health Sciences

People needed

20

Starts

2011-09-01

Expected to finish

2014-08-01

Last updated by the study team

2018-07-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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