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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01514 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 98309 | Other Identifier | Wake Forest University Health Sciences |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (cinacalcet hydrochloride) | Experimental | Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laboratory biomarker analysis | Other | Correlative study |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| K.C. Balaji, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Cinacalcet Hydrochloride) | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| quality-of-life assessment |
| Procedure |
Ancillary study |
|
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| questionnaire administration | Other | Ancillary study |
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| cinacalcet hydrochloride | Drug | Given PO |
|
|
| 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. |
| up to 20 weeks |
| 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. | up to 20 weeks |
| 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. | Up to 20 weeks |
| # Recieved Proper PSA Testing |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Cinacalcet Hydrochloride) | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | Nanograms Per Milliliter | 24 weeks |
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| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | Up to 20 weeks |
|
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| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | up to 20 weeks |
|
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| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | up to 20 weeks |
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| Secondary | 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. | No data collected | Posted | Up to 20 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Cinacalcet Hydrochloride) | 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 | 3 | 20 | 16 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| hypocalcemia | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Hypoxia | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Pulmonary hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Cardiac troponin T increased | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Neuropathy: sensory | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| hypocalcemia | Investigations | CTCAE (3.0) | Systematic Assessment |
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| hyponatremia | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Pruritus/itching | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain: Joint | General disorders | CTCAE (3.0) | Systematic Assessment |
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| hypertriglyceridemia | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Pain: Muscle | General disorders | CTCAE (3.0) | Systematic Assessment |
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| hypocalcemia | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. K.C. Balaji | Comprehensive Cancer Center of Wake Forest University | 336-618-2272 | kbalaji@wakehealth.edu |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000069449 | Cinacalcet |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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