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Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01054079
First received: January 21, 2010
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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 ]
    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.


Secondary Outcome Measures:
  • Change in total and free testosterone [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in quality of life (QOL) as assessed by the Brief Male Sexual Inventory, Hormonal Assessment Scale from Expanded Prostate Cancer Index Composite (EPIC), and Functional Assessment of Cancer Therapy-Prostate (FACT-P) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: September 2011
Estimated 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:

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.

  Eligibility

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

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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054079

Locations
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
Investigators
Principal Investigator: Gary Schwartz Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01054079     History of Changes
Other Study ID Numbers: CCCWFU 98309, NCI-2009-01514
Study First Received: January 21, 2010
Last Updated: April 22, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014