Clinical trial · Observational
Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer
LCCC 1231: Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer
NCT02008058CI-TRIAL-00044330completedClinicalTrials.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 is a single-arm observational longitudinal study in of patients with metastatic castrate-resistant prostate cancer designed to assess the longitudinal trajectory of pain and other symptoms.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castrate-Resistant Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Survey | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Single Arm
- description
- Surveys, diaries, clinical assessments of men with metastatic castrate-resistant prostate cancer
- interventionNames
- Behavioral: Survey
Primary outcomes (1)
- measure
- Proportion of pain palliation responders
- timeFrame
- 6 weeks
- description
- Determine the proportion of pain palliation responders and the proportion experiencing pain progression will be presented along with 95% confidence intervals.
Secondary outcomes (5)
- measure
- Clinical significance of pain score changes
- timeFrame
- 6 weeks
- description
- Determine the clinical significance of pain score changes. Pain score changes will be compared with each of the following "anchors": patient rating of change in pain, as well as changes in patient functional status, analgesic use, and various measures of disease status (imaging, PSA, circulating tumor cells). ROC curves derived using logistic regression analyses will be used to characterize the association between change in pain scores and clinically important improvement (defined by anchor variables).
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The subject must be ≥ 18 years old on the day of consent. * The subject is able to understand written and spoken English * The patient must have histologically or cytologically confirmed prostate adenocarcinoma. * The subject must have castration-resistant prostate cancer (CRPC) * The subject must have metastatic disease involving bone, seen on radiographic imaging (bone scan, CT scan, PET scan, or MRI). * The subject must be in a castrate state (e.g., currently receiving androgen deprivation therapy or have had an orchiectomy). * The subject must be starting any line treatment post-androgen deprivation/antiandrogen therapy, such as the following: chemotherapy (e.g., docetaxel, paclitaxel, carboplatin, cabazitaxel, or mitoxantrone); abiraterone acetate; MDV3100; ketoconazole; sipuleucel-T; Radium 223. * The subject owns or has regular access to a telephone (cellular or land line). * The subject is willing and able to self-report pain and analgesic use via an automated telephone system. * The subject is willing and able to provide informed consent. Exclusion Criteria: * The subject has small cell or predominantly neuroendocrine differentiated prostate tumor.
References
Publications (0)
Data not yet available
No reference posted for this study.