Clinical trial NCT01054079: Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-01-22
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of Rise of Serum PSA
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in Quality of Life (QOL) as Assessed by the Brief Male Sexual Inventory
timeFrame: Up to 20 weeks
measure: Change in Hormonal Assessment Scale From Expanded Prostate Cancer Index Composite (EPIC)
timeFrame: up to 20 weeks
measure: Change in Functional Assessment of Cancer Therapy-Prostate (FACT-P)
timeFrame: up to 20 weeks
measure: Change in Total and Free Testosterone
timeFrame: Up to 20 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: K.C. Balaji, MD
role: PRINCIPAL_INVESTIGATOR
References: