NCT01054079

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2010

Completed
1.6 years until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 29, 2015

Completed
Last Updated

July 5, 2018

Status Verified

July 1, 2018

Enrollment Period

2.9 years

First QC Date

January 21, 2010

Results QC Date

August 14, 2015

Last Update Submit

July 2, 2018

Conditions

Adenocarcinoma of the ProstateRecurrent Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in Quality of Life (QOL) as Assessed by the Brief Male Sexual Inventory

    Up to 20 weeks

  • Change in Hormonal Assessment Scale From Expanded Prostate Cancer Index Composite (EPIC)

    up to 20 weeks

  • Change in Functional Assessment of Cancer Therapy-Prostate (FACT-P)

    up to 20 weeks

  • Change in Total and Free Testosterone

    Up to 20 weeks

Study Arms (1)

Treatment (cinacalcet hydrochloride)

EXPERIMENTAL

Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysisProcedure: quality-of-life assessmentOther: questionnaire administrationDrug: cinacalcet hydrochloride

Interventions

laboratory biomarker analysisOTHER

Correlative study

Treatment (cinacalcet hydrochloride)
quality-of-life assessmentPROCEDURE

Ancillary study

Also known as: quality of life assessment
Treatment (cinacalcet hydrochloride)
questionnaire administrationOTHER

Ancillary study

Treatment (cinacalcet hydrochloride)
cinacalcet hydrochlorideDRUG

Given PO

Also known as: Mimpara, Sensipar
Treatment (cinacalcet hydrochloride)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Dr. K.C. Balaji
Organization
Comprehensive Cancer Center of Wake Forest University
kbalaji@wakehealth.edu
336-618-2272

Study Officials

  • K.C. Balaji, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2010

First Posted

January 22, 2010

Study Start

September 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

July 5, 2018

Results First Posted

October 29, 2015

Record last verified: 2018-07

Locations

US(1)