Adenocarcinoma of the Prostate, Recurrent Prostate Cancer
Conditions
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.
Interventions
OTHERlaboratory biomarker analysis
Correlative study
PROCEDUREquality-of-life assessment
Ancillary study
OTHERquestionnaire administration
Ancillary study
Given PO
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Rise of Serum PSA | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life (QOL) as Assessed by the Brief Male Sexual Inventory | 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) | 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) | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Treatment (Cinacalcet Hydrochloride) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 66.6 years STANDARD_DEVIATION 7.1 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 20 |
| serious Total, serious adverse events | 3 / 20 |
Outcome results
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.
Time frame: 24 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment (Cinacalcet Hydrochloride) | Rate of Rise of Serum PSA | 0.0825 Nanograms Per Milliliter |
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.
Time frame: up to 20 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment (Cinacalcet Hydrochloride) | Change in Functional Assessment of Cancer Therapy-Prostate (FACT-P) | baseline | 122.4 units on a scale | Standard Error 3.4 |
| Treatment (Cinacalcet Hydrochloride) | Change in Functional Assessment of Cancer Therapy-Prostate (FACT-P) | 20 weeks | 124.1 units on a scale | Standard Error 3.1 |
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.
Time frame: up to 20 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment (Cinacalcet Hydrochloride) | Change in Hormonal Assessment Scale From Expanded Prostate Cancer Index Composite (EPIC) | baseline function | 86 units on a scale | Standard Error 2.8 |
| Treatment (Cinacalcet Hydrochloride) | Change in Hormonal Assessment Scale From Expanded Prostate Cancer Index Composite (EPIC) | 20 weeks function | 88 units on a scale | Standard Error 3.1 |
| Treatment (Cinacalcet Hydrochloride) | Change in Hormonal Assessment Scale From Expanded Prostate Cancer Index Composite (EPIC) | baseline bother | 92.6 units on a scale | Standard Error 1.6 |
| Treatment (Cinacalcet Hydrochloride) | Change in Hormonal Assessment Scale From Expanded Prostate Cancer Index Composite (EPIC) | 20 weeks bother | 91.9 units on a scale | Standard Error 1.6 |
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.
Time frame: Up to 20 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment (Cinacalcet Hydrochloride) | Change in Quality of Life (QOL) as Assessed by the Brief Male Sexual Inventory | baseline | 23.7 units on a scale | Standard Error 2.7 |
| Treatment (Cinacalcet Hydrochloride) | Change in Quality of Life (QOL) as Assessed by the Brief Male Sexual Inventory | 20 weeks | 21.8 units on a scale | Standard Error 2.2 |
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.
Time frame: Up to 20 weeks
Population: No data collected