Prostate Cancer Clinical Trial

Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer

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

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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.

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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)

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

20

Study ID:

NCT01054079

Recruitment Status:

Completed

Sponsor:

Wake Forest University Health Sciences

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There is 1 Location for this study

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Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

20

Study ID:

NCT01054079

Recruitment Status:

Completed

Sponsor:


Wake Forest University Health Sciences

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