Trial Outcomes & Findings for Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer (NCT NCT01054079)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

24 weeks

Results posted on

2018-07-05

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	20
Overall Study # Recieved Proper PSA Testing	10
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Cinacalcet Hydrochloride) n=20 Participants 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
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=93 Participants
Age, Categorical >=65 years	8 Participants n=93 Participants
Age, Continuous	66.6 years STANDARD_DEVIATION 7.1 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	20 Participants n=93 Participants
Region of Enrollment United States	20 participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment (Cinacalcet Hydrochloride) n=10 Participants 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
Rate of Rise of Serum PSA	0.0825 Nanograms Per Milliliter Interval -0.01 to 0.17

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment (Cinacalcet Hydrochloride) n=10 Participants 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
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
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

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment (Cinacalcet Hydrochloride) n=10 Participants 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
Change in Hormonal Assessment Scale From Expanded Prostate Cancer Index Composite (EPIC) baseline function	86 units on a scale Standard Error 2.8
Change in Hormonal Assessment Scale From Expanded Prostate Cancer Index Composite (EPIC) 20 weeks function	88 units on a scale Standard Error 3.1
Change in Hormonal Assessment Scale From Expanded Prostate Cancer Index Composite (EPIC) baseline bother	92.6 units on a scale Standard Error 1.6
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment (Cinacalcet Hydrochloride) n=10 Participants 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
Change in Functional Assessment of Cancer Therapy-Prostate (FACT-P) baseline	122.4 units on a scale Standard Error 3.4
Change in Functional Assessment of Cancer Therapy-Prostate (FACT-P) 20 weeks	124.1 units on a scale Standard Error 3.1

SECONDARY outcome

Timeframe: Up to 20 weeks

Population: No data collected

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.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Cinacalcet Hydrochloride)

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Cinacalcet Hydrochloride) n=20 participants at risk 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
Cardiac disorders Cardiac ischemia/infarction	5.0% 1/20 • Number of events 1
Investigations hypocalcemia	5.0% 1/20 • Number of events 1
Investigations Hypoxia	5.0% 1/20 • Number of events 1
Cardiac disorders Atrial fibrillation	5.0% 1/20 • Number of events 1
Investigations Lymphopenia	5.0% 1/20 • Number of events 1
Cardiac disorders Pulmonary hypertension	5.0% 1/20 • Number of events 1
Investigations Cardiac troponin T increased	5.0% 1/20 • Number of events 1

Other adverse events

Other adverse events
Measure	Treatment (Cinacalcet Hydrochloride) n=20 participants at risk 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
Gastrointestinal disorders Nausea	10.0% 2/20 • Number of events 5
Gastrointestinal disorders Diarrhea	5.0% 1/20 • Number of events 1
Cardiac disorders Neuropathy: sensory	15.0% 3/20 • Number of events 3
Investigations hypocalcemia	10.0% 2/20 • Number of events 2
Investigations hyponatremia	5.0% 1/20 • Number of events 1
General disorders Pruritus/itching	5.0% 1/20 • Number of events 1
General disorders Pain: Joint	5.0% 1/20 • Number of events 4
Investigations hypertriglyceridemia	5.0% 1/20 • Number of events 1
General disorders Pain: Muscle	5.0% 1/20 • Number of events 1

Additional Information

Dr. K.C. Balaji

Comprehensive Cancer Center of Wake Forest University

Phone: 336-618-2272

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place