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A Phase II Trial to Assess the Effect of Cinacalcet Hydrochloride on PSA Levels in Patients With Biochemically Recurrent Prostate Cancer After Failed Definitive Local Therapy


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer

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Trial Information

A Phase II Trial to Assess the Effect of Cinacalcet Hydrochloride on PSA Levels in Patients With Biochemically Recurrent Prostate Cancer After Failed Definitive Local Therapy


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.

SECONDARY OBJECTIVES:

I. To assess the effects of cinacalcet hydrochloride on serum calcium, parathyroid hormone
(PTH), total and free testosterone levels in these patients.

II. To assess the effects of cinacalcet hydrochloride on sexual functioning and quality of
life in these patients.

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"), the 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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of rise of serum PSA

Outcome Description:

For each participant, PSA doubling time (DT) before and after enrollment will be estimated by linear regression. Median PSADT before enrollment will be compared to that after enrollment using a Wilcoxon rank sum test. We will analyze the on-study PSA measures longitudinally using all measures with a mixed model approach adjusting for individual covariates (e.g., age, stage of cancer, time since diagnosis). A further model that we will fit includes baseline PSA as a covariate.

Outcome Time Frame:

24 weeks

Safety Issue:

No

Principal Investigator

Gary Schwartz

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 98309

NCT ID:

NCT01054079

Start Date:

September 2011

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Recurrent Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

Name

Location

Wake Forest University Health SciencesWinston-Salem, North Carolina  27157