Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University Identifier:
First received: January 21, 2010
Last updated: September 29, 2015
Last verified: September 2015
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

Condition Intervention Phase
Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Other: laboratory biomarker analysis
Procedure: quality-of-life assessment
Other: questionnaire administration
Drug: cinacalcet hydrochloride
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Rate of Rise of Serum PSA [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The difference of post treatment and pre-enrollment PSA.For those with multiple PSA measures post we use the median of those measures to estimate the participant's post PSA level.

Enrollment: 20
Study Start Date: September 2011
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (cinacalcet hydrochloride)
Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
Correlative study
Procedure: quality-of-life assessment
Ancillary study
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary study
Drug: cinacalcet hydrochloride
Given PO
Other Names:
  • Mimpara
  • Sensipar

Detailed Description:


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.


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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT01054079

United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Principal Investigator: K.C. Balaji, MD Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University Identifier: NCT01054079     History of Changes
Other Study ID Numbers: CCCWFU 98309, NCI-2009-01514
Study First Received: January 21, 2010
Results First Received: August 14, 2015
Last Updated: September 29, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Urogenital Neoplasms processed this record on November 27, 2015