Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer

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

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

Study Overview

• Status: Completed
• Conditions: Recurrent Prostate Cancer; Adenocarcinoma of the Prostate
• Intervention / Treatment: Other: laboratory biomarker analysis; Procedure: quality-of-life assessment; Other: questionnaire administration; Drug: cinacalcet hydrochloride

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (cinacalcet hydrochloride); Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.	Other: laboratory biomarker analysis; Correlative study; Procedure: quality-of-life assessment; Ancillary study; Other Names: quality of life assessment; Other: questionnaire administration; Ancillary study; Drug: cinacalcet hydrochloride; Given PO; Other Names: Mimpara; Sensipar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: K.C. Balaji, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: January 21, 2010
• First Submitted That Met QC Criteria: January 21, 2010
• First Posted (Estimate): January 22, 2010

Study Record Updates

• Last Update Posted (Actual): July 5, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Disease Attributes; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Recurrence; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Calcium-Regulating Hormones and Agents; Calcimimetic Agents; Cinacalcet
• Other Study ID Numbers: IRB00009741; NCI-2009-01514 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CCCWFU 98309 (Other Identifier: Wake Forest University Health Sciences)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No