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Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01054079
Recruitment Status : Completed
First Posted : January 22, 2010
Results First Posted : October 29, 2015
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

January 21, 2010
January 22, 2010
August 14, 2015
October 29, 2015
May 11, 2018
September 2011
August 2014   (Final data collection date for primary outcome measure)
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.
Rate of Rise of Serum PSA [ Time Frame: Baseline, weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24 ]
Complete list of historical versions of study NCT01054079 on ClinicalTrials.gov Archive Site
  • Change in Quality of Life (QOL) as Assessed by the Brief Male Sexual Inventory [ Time Frame: Up to 20 weeks ]
    The Brief Male Sexual Inventory is an 11 question assessment including subscales: sex drive, erections, ejaculation. The scores are totaled to produce an overall score with a range of 1-45, with higher score indicating worse outcomes.
  • Change in Hormonal Assessment Scale From Expanded Prostate Cancer Index Composite (EPIC) [ Time Frame: up to 20 weeks ]
    The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Epic produces two scores, one for function (5 items) and the other for bother (6 items). The response for each item is standardized to a 0 to 100 scale. For both scales, higher scores indicate worse outcomes.
  • Change in Functional Assessment of Cancer Therapy-Prostate (FACT-P) [ Time Frame: up to 20 weeks ]
    The FACT-P is a multidimensional, self-report QoL instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain, as well as a global QoL score. All subscale items are summed to a total. The score range is 0-156. Higher scores represent better quality of life.
  • Change in Total and Free Testosterone [ Time Frame: Up to 20 weeks ]
    The detectable difference is estimated using a paired t-test approach. The lab measure will also be analyzed longitudinally using all measures with a mixed model approach adjusting for individual covariates.
  • Total and free testosterone [ Time Frame: At baseline and at weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 ]
  • 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 ]
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
Intervention Model: Single Group Assignment
Masking: None (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.
 
Completed
20
18
August 2014
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)
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01054079
CCCWFU 98309
NCI-2009-01514 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Wake Forest University Health Sciences
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Principal Investigator: K.C. Balaji, MD Wake Forest University Health Sciences
Wake Forest University Health Sciences
April 2018

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