Clinical trial · Interventional
Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer
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
NCT01054079CI-TRIAL-00033635completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cinacalcet hydrochloride | Drug | Cinacalcet | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (cinacalcet hydrochloride)
- description
- Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: laboratory biomarker analysis
- Procedure: quality-of-life assessment
- Other: questionnaire administration
- Drug: cinacalcet hydrochloride
Primary outcomes (1)
- measure
- Rate of Rise of Serum PSA
- timeFrame
- 24 weeks
- description
- 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.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)References
Publications (0)
Data not yet available
No reference posted for this study.