Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer

Wake Forest University (WFU)

Status and phase: Completed; Phase 2

Conditions: Adenocarcinoma of the Prostate; Recurrent Prostate Cancer

Treatments: Drug: cinacalcet hydrochloride; Other: questionnaire administration; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01054079

IRB00009741

NCI-2009-01514 (Registry Identifier)

CCCWFU 98309 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

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.

Enrollment: 20 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Treatment (cinacalcet hydrochloride)

Experimental group

Description:

Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.

Treatment:

Other: questionnaire administration

Procedure: quality-of-life assessment

Other: laboratory biomarker analysis

Drug: cinacalcet hydrochloride