Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01054079
First received: January 21, 2010
Last updated: September 29, 2015
Last verified: September 2015

January 21, 2010
September 29, 2015
September 2011
August 2014   (final data collection date for primary outcome measure)
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.
Rate of Rise of Serum PSA [ Time Frame: Baseline, weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01054079 on ClinicalTrials.gov Archive Site
Not Provided
  • Total and free testosterone [ Time Frame: At baseline and at weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 ] [ Designated as safety issue: No ]
  • Quality of life as assessed by the Brief Male Sexual Inventory, Hormonal Assessment Scale from EPIC, and Functional Assessment of Cancer Therapy-Prostate (FACT-P) [ Time Frame: At baseline and at weeks 10 and 20 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer
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
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

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Adenocarcinoma of the Prostate
  • Recurrent Prostate Cancer
  • 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
Experimental: Treatment (cinacalcet hydrochloride)
Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Other: laboratory biomarker analysis
  • Procedure: quality-of-life assessment
  • Other: questionnaire administration
  • Drug: cinacalcet hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
Not Provided
August 2014   (final data collection date for primary outcome measure)

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)
Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01054079
CCCWFU 98309, NCI-2009-01514
No
Not Provided
Not Provided
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Principal Investigator: K.C. Balaji, MD Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP