Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer

Study Overview
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Brief Summary
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The first goal of this study is to learn more about the experience of pain and other symptoms in men being treated for advanced prostate cancer. The second goal of the study is to identify reliable ways of measuring pain which will be used in future clinical trials of treatments for advanced prostate cancer.

Official Title
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Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Webcore telephone survey system


Participation Criteria
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Eligibility Criteria
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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 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: The subject has small cell or predominantly neuroendocrine differentiated prostate tumor.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| assessments completed by patients<br>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. | Behavioral: Webcore telephone survey system<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | Pain score changes will be correlated with each of the following: 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). The distribution-based approach is to estimate meaningful change as one-half a standard deviation of the sample mean pain score. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate, pain assessment, 12-110