search
Back to results

Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer

Primary Purpose

Adenocarcinoma of the Prostate, Recurrent Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
laboratory biomarker analysis
quality-of-life assessment
questionnaire administration
cinacalcet hydrochloride
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (cinacalcet hydrochloride)

Arm Description

Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Rate of Rise of Serum PSA
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.

Secondary Outcome Measures

Change in Quality of Life (QOL) as Assessed by the Brief Male Sexual Inventory
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)
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)
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
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.

Full Information

First Posted
January 21, 2010
Last Updated
July 2, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT01054079
Brief Title
Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (cinacalcet hydrochloride)
Arm Type
Experimental
Arm Description
Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative study
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary study
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary study
Intervention Type
Drug
Intervention Name(s)
cinacalcet hydrochloride
Other Intervention Name(s)
Mimpara, Sensipar
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Rate of Rise of Serum PSA
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in Quality of Life (QOL) as Assessed by the Brief Male Sexual Inventory
Description
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.
Time Frame
Up to 20 weeks
Title
Change in Hormonal Assessment Scale From Expanded Prostate Cancer Index Composite (EPIC)
Description
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.
Time Frame
up to 20 weeks
Title
Change in Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Description
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.
Time Frame
up to 20 weeks
Title
Change in Total and Free Testosterone
Description
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.
Time Frame
Up to 20 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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") 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K.C. Balaji, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer

We'll reach out to this number within 24 hrs