Phase 2
Completed N=20
Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer
Prostate Cancer · Recurrent Prostate Cancer
Source: ClinicalTrials.gov NCT01054079 ↗
Enrolled (actual)
20
Serious AEs
15.0%
Results posted
Oct 2015
Primary outcomePrimary: Rate of Rise of Serum PSA — 0.0825 Nanograms Per Milliliter
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
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 |
— | — |
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. Informational only — not medical advice.