## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** IRB00009741
#### Organization
**Class:** OTHER
**Full Name:** Wake Forest University Health Sciences
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2009-01514
**Type:** REGISTRY
**Domain:** Wake Forest University Health Sciences
**ID:** CCCWFU 98309
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2014-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-07-05

**Type:** ACTUAL

**Last Update Submit Date:** 2018-07-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-08

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2015-10-29

**Type:** ESTIMATED

**Results First Submit Date:** 2015-08-14

**Results First Submit QC Date:** 2015-09-29

#### Start Date
**Date:** 2011-09

**Status Verified Date:** 2018-07

#### Study First Post Date
**Date:** 2010-01-22
**Type:** ESTIMATED
**Study First Submit Date:** 2010-01-21
**Study First Submit QC Date:** 2010-01-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** Wake Forest University Health Sciences

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Adenocarcinoma of the Prostate

- Recurrent Prostate Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: laboratory biomarker analysis

- Procedure: quality-of-life assessment

- Other: questionnaire administration

- Drug: cinacalcet hydrochloride

**Label:** Treatment (cinacalcet hydrochloride)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment (cinacalcet hydrochloride)

**Description:** Correlative study

**Name:** laboratory biomarker analysis

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Treatment (cinacalcet hydrochloride)

**Description:** Ancillary study

**Name:** quality-of-life assessment

**Other Names:**

- quality of life assessment

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- Treatment (cinacalcet hydrochloride)

**Description:** Ancillary study

**Name:** questionnaire administration

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Treatment (cinacalcet hydrochloride)

**Description:** Given PO

**Name:** cinacalcet hydrochloride

**Other Names:**

- Mimpara

- Sensipar

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**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.

**Measure:** Rate of Rise of Serum PSA

**Time Frame:** 24 weeks

#### Secondary Outcomes

**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.

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

**Time Frame:** Up to 20 weeks

**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.

**Measure:** Change in Hormonal Assessment Scale From Expanded Prostate Cancer Index Composite (EPIC)

**Time Frame:** up to 20 weeks

**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.

**Measure:** Change in Functional Assessment of Cancer Therapy-Prostate (FACT-P)

**Time Frame:** up to 20 weeks

**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.

**Measure:** Change in Total and Free Testosterone

**Time Frame:** Up to 20 weeks

### Eligibility Module

**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)

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Winston-Salem

**Country:** United States

**Facility:** Wake Forest University Health Sciences

**State:** North Carolina

**Zip:** 27157

#### Overall Officials

**Official 1:**

**Affiliation:** Wake Forest University Health Sciences

**Name:** K.C. Balaji, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000005834

- Term: Genital Neoplasms, Male

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: HIGH

- As Found: Prostate Cancer

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M14850

- Name: Recurrence

- Relevance: HIGH

- As Found: Recurrent

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M8946

- Name: Genital Neoplasms, Male

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011471

- Term: Prostatic Neoplasms

- ID: D000012008

- Term: Recurrence

### Intervention Browse Module - Ancestors

- ID: D000077264

- Term: Calcium-Regulating Hormones and Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000057966

- Term: Calcimimetic Agents

- ID: D000006727

- Term: Hormone Antagonists

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

### Intervention Browse Module - Browse Leaves

- ID: M418

- Name: Cinacalcet

- Relevance: HIGH

- As Found: FGFR

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069449

- Term: Cinacalcet

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Treatment (Cinacalcet Hydrochloride)

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

laboratory biomarker analysis: Correlative study

quality-of-life assessment: Ancillary study

questionnaire administration: Ancillary study

cinacalcet hydrochloride: Given PO

**ID:** EG000

**Other Num Affected:** 16

**Other Num at Risk:** 20

**Serious Number Affected:** 3

**Serious Number At Risk:** 20

**Title:** Treatment (Cinacalcet Hydrochloride)

**Frequency Threshold:** 0

#### Other Events

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Diarrhea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Neuropathy: sensory

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** hypocalcemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** hyponatremia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Pruritus/itching

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Pain: Joint

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** hypertriglyceridemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

**Term:** Pain: Muscle

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** hypocalcemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

#### Serious Events

**Term:** Cardiac ischemia/infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Term:** hypocalcemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Term:** Hypoxia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Term:** Atrial fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Term:** Lymphopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Term:** Pulmonary hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

**Term:** Cardiac troponin T increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 20

**Num Events:** 1

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Units:** Participants

### Group

**ID:** BG000

**Title:** Treatment (Cinacalcet Hydrochloride)

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

laboratory biomarker analysis: Correlative study

quality-of-life assessment: Ancillary study

questionnaire administration: Ancillary study

cinacalcet hydrochloride: Given PO

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 12

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 8

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 7.1

**Value:** 66.6

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 20

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 20

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** kbalaji@wakehealth.edu
**Organization:** Comprehensive Cancer Center of Wake Forest University
**Phone:** 336-618-2272
**Title:** Dr. K.C. Balaji
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.01
- **Spread:** 
- **Upper Limit:** 0.17
- **Value:** 0.0825
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.7
- **Upper Limit:** 
- **Value:** 23.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.2
- **Upper Limit:** 
- **Value:** 21.8
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.8
- **Upper Limit:** 
- **Value:** 86
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.1
- **Upper Limit:** 
- **Value:** 88
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.6
- **Upper Limit:** 
- **Value:** 92.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.6
- **Upper Limit:** 
- **Value:** 91.9
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.4
- **Upper Limit:** 
- **Value:** 122.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.1
- **Upper Limit:** 
- **Value:** 124.1
**Title:** 
#### Outcome Measure 5
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**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.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** 24 weeks
**Title:** Rate of Rise of Serum PSA
**Type:** PRIMARY
**Unit of Measure:** Nanograms Per Milliliter
##### Group
**Description:** Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Correlative study

quality-of-life assessment: Ancillary study

questionnaire administration: Ancillary study

cinacalcet hydrochloride: Given PO
**ID:** OG000
**Title:** Treatment (Cinacalcet Hydrochloride)
#### Outcome Measure 2
**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.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Up to 20 weeks
**Title:** Change in Quality of Life (QOL) as Assessed by the Brief Male Sexual Inventory
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Correlative study

quality-of-life assessment: Ancillary study

questionnaire administration: Ancillary study

cinacalcet hydrochloride: Given PO
**ID:** OG000
**Title:** Treatment (Cinacalcet Hydrochloride)
#### Outcome Measure 3
**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.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** up to 20 weeks
**Title:** Change in Hormonal Assessment Scale From Expanded Prostate Cancer Index Composite (EPIC)
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Correlative study

quality-of-life assessment: Ancillary study

questionnaire administration: Ancillary study

cinacalcet hydrochloride: Given PO
**ID:** OG000
**Title:** Treatment (Cinacalcet Hydrochloride)
#### Outcome Measure 4
**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.
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** up to 20 weeks
**Title:** Change in Functional Assessment of Cancer Therapy-Prostate (FACT-P)
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Correlative study

quality-of-life assessment: Ancillary study

questionnaire administration: Ancillary study

cinacalcet hydrochloride: Given PO
**ID:** OG000
**Title:** Treatment (Cinacalcet Hydrochloride)
#### Outcome Measure 5
**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.
**Population Description:** No data collected
**Reporting Status:** POSTED
**Time Frame:** Up to 20 weeks
**Title:** Change in Total and Free Testosterone
**Type:** SECONDARY
##### Group
**Description:** Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Correlative study

quality-of-life assessment: Ancillary study

questionnaire administration: Ancillary study

cinacalcet hydrochloride: Given PO
**ID:** OG000
**Title:** Treatment (Cinacalcet Hydrochloride)
### Participant Flow Module
#### Group
**Description:** Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.

laboratory biomarker analysis: Correlative study

quality-of-life assessment: Ancillary study

questionnaire administration: Ancillary study

cinacalcet hydrochloride: Given PO
**ID:** FG000
**Title:** Treatment (Cinacalcet Hydrochloride)
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 20
##### Milestone
**Type:** # Recieved Proper PSA Testing
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 10
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 20
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Has Results:** True