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



Status:Active, not recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:January 23, 2014
End Date:December 2021

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LCCC 1231: Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer

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.

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. The study aims to address several key methodological questions that will
inform the design of future clinical trials with symptom endpoints in this population,
including: the definition of "clinically meaningful" pain; criteria for concluding a
clinically meaningful pain reduction; criteria for concluding clinically meaningful pain
progression; reliable methods quantifying analgesic use (given that "equianalgesic tables"
and "point scoring systems" are generally considered unreliable by pain researchers and
regulatory agencies , , ); ideal recall periods for pain questions; tradeoffs of different
frequencies of symptom reporting; symptom trajectories over time; and associations of pain
scores with other metrics used in prostate cancer research (imaging, PSA values, circulating
tumor cells, etc).

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.
We found this trial at
4
sites
Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Celestia Higano, MD
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Michael Carducci, MD
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Tomasz Beer Beer, MD
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Chapel Hill, North Carolina 27599
Principal Investigator: Ethan Basch, MD
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Chapel Hill, NC
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