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

Completed

Conditions studied: Metastatic Castrate-Resistant Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02008058

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

213

Starts

2014-01-23

Expected to finish

2017-09-30

Last updated by the study team

2020-03-30

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• The subject has small cell or predominantly neuroendocrine differentiated prostate tumor.

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States
• Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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