Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer

NCT ID: NCT01054079

Last Updated: 2018-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-08-31

Brief 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

Detailed 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.

Conditions

Adenocarcinoma of the Prostate; Recurrent Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (cinacalcet hydrochloride)

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

Group Type: EXPERIMENTAL

laboratory biomarker analysis

Intervention Type: OTHER

Correlative study

quality-of-life assessment

Intervention Type: PROCEDURE

Ancillary study

questionnaire administration

Intervention Type: OTHER

Ancillary study

cinacalcet hydrochloride

Intervention Type: DRUG

Given PO

Interventions

laboratory biomarker analysis

Correlative study

Intervention Type: OTHER

quality-of-life assessment

Ancillary study

Intervention Type: PROCEDURE

questionnaire administration

Ancillary study

Intervention Type: OTHER

cinacalcet hydrochloride

Given PO

Intervention Type: DRUG

Other Intervention Names

quality of life assessment; Mimpara; Sensipar

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

K.C. Balaji, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

NCI-2009-01514

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCCWFU 98309

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00009741

Identifier Type: -

Identifier Source: org_study_id