Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer
NCT ID: NCT01617174
Last Updated: 2013-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2012-06-30
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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assessments completed by patients
A single-arm observational study will be conducted at three institutions in the Prostate Cancer Clinical Trials Consortium (PCCTC): Memorial Sloan-Kettering Cancer Center; Johns Hopkins; and Oregon Health \& Science University. MSKCC is the coordinating center. The target enrollment is 400 patients, with at least 250 experiencing "moderate or worse" pain intensity at baseline, defined as a score of ≥4, the preferred regulatory cutoff.
Webcore telephone survey system
Patients will report pain and analgesic use through the automated telephone system, for 7 days in a row, once every 6 weeks. Data from diagnostic tests (CT Abdomen/Pelvis, Bone Scan, PSA, and circulating tumor cells) conducted during the study period will be collected from medical records by local personnel and entered into the secure online database quarterly, but no specific tests or schedules will be required in this observational study.
Interventions
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Webcore telephone survey system
Patients will report pain and analgesic use through the automated telephone system, for 7 days in a row, once every 6 weeks. Data from diagnostic tests (CT Abdomen/Pelvis, Bone Scan, PSA, and circulating tumor cells) conducted during the study period will be collected from medical records by local personnel and entered into the secure online database quarterly, but no specific tests or schedules will be required in this observational study.
Eligibility Criteria
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Inclusion Criteria
* 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 of systemic treatment post-androgen deprivation/antiandrogen therapy, with any of the following: chemotherapy (e.g., docetaxel, paclitaxel, carboplatin, cabazitaxel, or mitoxantrone); abiraterone acetate; MDV3100; ketoconazole; a clinical trial.
* 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
18 Years
MALE
No
Sponsors
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Oregon Health and Science University
OTHER
Johns Hopkins University
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Michael Morris, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Countries
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Related Links
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Memorial Sloan-Kettering Cancer Center
Other Identifiers
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12-110
Identifier Type: -
Identifier Source: org_study_id