Phase 2
N=20
Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer
Adenocarcinoma of the Prostate · Recurrent Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01054079 ↗Enrolled (actual)
20
Serious AEs
15.0%
Results posted
Oct 2015
Primary outcome: Primary: Rate of Rise of Serum PSA — 0.0825 Nanograms Per Milliliter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- laboratory biomarker analysis (Other); quality-of-life assessment (Procedure); questionnaire administration (Other); cinacalcet hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Rise of Serum PSA |
0.0825 | — |
| SECONDARY Change in Quality of Life (QOL) as Assessed by the Brief Male Sexual Inventory |
23.7; 21.8 | — |
| SECONDARY Change in Hormonal Assessment Scale From Expanded Prostate Cancer Index Composite (EPIC) |
86; 88; 92.6; 91.9 | — |
| SECONDARY Change in Functional Assessment of Cancer Therapy-Prostate (FACT-P) |
122.4; 124.1 | — |
| SECONDARY Change in Total and Free Testosterone |
— | — |
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
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 = = 1000/uL
- Serum creatinine = 9.0 and =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)
Data sourced from ClinicalTrials.gov (NCT01054079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.