A Phase 2 interventional study of laboratory biomarker analysis and quality-of-life assessment in Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-05.
Sponsored by Wake Forest University Health Sciences · Phase 2, Interventional, and Treatment
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.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's enrollment of 20 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 198 are open to participants now.
Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.
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Exclusion Criteria:
Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis · Procedure: quality-of-life assessment · Other: questionnaire administration · Drug: cinacalcet hydrochloride
Correlative study
Ancillary study
Also known as: quality of life assessment
Ancillary study
Given PO
Also known as: Mimpara, Sensipar
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
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
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
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
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
| Milestone | Treatment (Cinacalcet Hydrochloride) |
|---|---|
| Started | 20 |
| # recieved proper psa testing | 10 |
| Completed | 20 |
| Not completed | 0 |
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.
| Nanograms Per Milliliter | Treatment (Cinacalcet Hydrochloride) |
|---|---|
| Rate of Rise of Serum PSA | 0.0825 (-0.01 to 0.17) |
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.
| units on a scale | Treatment (Cinacalcet Hydrochloride) |
|---|---|
| baseline | 23.7 ± 2.7 |
| 20 weeks | 21.8 ± 2.2 |
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.
| units on a scale | Treatment (Cinacalcet Hydrochloride) |
|---|---|
| baseline function | 86 ± 2.8 |
| 20 weeks function | 88 ± 3.1 |
| baseline bother | 92.6 ± 1.6 |
| 20 weeks bother | 91.9 ± 1.6 |
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.
| units on a scale | Treatment (Cinacalcet Hydrochloride) |
|---|---|
| baseline | 122.4 ± 3.4 |
| 20 weeks | 124.1 ± 3.1 |
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 measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Cinacalcet Hydrochloride) | — | 3/20 (15%) | 16/20 (80%) |
| Event | Treatment (Cinacalcet Hydrochloride) |
|---|---|
| Cardiac ischemia/infarctionCardiac disorders | 1/20 |
| hypocalcemiaInvestigations | 1/20 |
| HypoxiaInvestigations | 1/20 |
| Atrial fibrillationCardiac disorders | 1/20 |
| LymphopeniaInvestigations | 1/20 |
| Pulmonary hypertensionCardiac disorders | 1/20 |
| Cardiac troponin T increasedInvestigations | 1/20 |
| Event | Treatment (Cinacalcet Hydrochloride) |
|---|---|
| hypocalcemiaInvestigations | 14/20 |
| Neuropathy: sensoryCardiac disorders | 3/20 |
| NauseaGastrointestinal disorders | 2/20 |
| hypocalcemiaInvestigations | 2/20 |
| DiarrheaGastrointestinal disorders | 1/20 |
| hyponatremiaInvestigations | 1/20 |
| Pruritus/itchingGeneral disorders | 1/20 |
| Pain: JointGeneral disorders | 1/20 |
| hypertriglyceridemiaInvestigations | 1/20 |
| Pain: MuscleGeneral disorders | 1/20 |
| Age, Categorical(Participants) | Treatment (Cinacalcet Hydrochloride) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 8 |
| Age, Continuous(years) | Treatment (Cinacalcet Hydrochloride) |
|---|---|
| Mean | 66.6 ± 7.1 |
| Sex: Female, Male(Participants) | Treatment (Cinacalcet Hydrochloride) |
|---|---|
| Female | 0 |
| Male | 20 |
| Region of Enrollment(participants) | Treatment (Cinacalcet Hydrochloride) |
|---|---|
| United States | 20 |
The record gives a start of Sep 2011, a primary completion of Aug 2014 and a completion of Aug 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2015, 1 year 2 months after primary completion.
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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cinacalcet
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