Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Wake Forest University Health Sciences
With
National Cancer Institute (NCI)
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.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible 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 be 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)
Clareo Health | Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer
