Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01054079
Recruitment Status : Unknown
Verified September 2015 by Wake Forest University Health Sciences.
Recruitment status was:  Active, not recruiting
First Posted : January 22, 2010
Results First Posted : October 29, 2015
Last Update Posted : October 29, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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

Condition or disease Intervention/treatment 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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2011
Actual Primary Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Rate of Rise of Serum PSA [ Time Frame: 24 weeks ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01054079

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

Responsible Party: Wake Forest University Health Sciences Identifier: NCT01054079     History of Changes
Other Study ID Numbers: CCCWFU 98309
NCI-2009-01514 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: January 22, 2010    Key Record Dates
Results First Posted: October 29, 2015
Last Update Posted: October 29, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cinacalcet Hydrochloride
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs