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



Status:Completed
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/23/2013
Start Date:June 2012
End Date:June 2014
Contact:Michael Morris, MD
Phone:646-422-4469

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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.


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.
We found this trial at
3
sites
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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1275 York Avenue
New York, New York 10065
212-639-2000
Memorial Sloan-Kettering Cancer Center Memorial Sloan-Kettering Cancer Center — the world's oldest and largest private...
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Baltimore, Maryland 21287
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Baltimore, MD
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