Clinical trial NCT02008058: Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer
Official title: LCCC 1231: Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Castrate-Resistant Prostate Cancer
Keywords: Metastatic Castrate-Resistant Prostate Cancer
LCCC 1231
Lineberger Comprehensive Cancer Center
UNC Lineberger
Prostate Cancer
Pain
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Memorial Sloan Kettering Cancer Center
name: Johns Hopkins University
name: University of Washington
name: Oregon Health and Science University
First posted: 2013-12-11
Enrollment: 213
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Oncology clinic

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of pain palliation responders
timeFrame: 6 weeks
Secondary outcomes:
measure: Clinical significance of pain score changes
timeFrame: 6 weeks
measure: Prevalence and trajectory of pain progression and pain palliation
timeFrame: 3 weeks
measure: Quantifying analgesic medication use
timeFrame: 26 months
measure: Frequency of pain reporting
timeFrame: 7 days
measure: Web-avidity of patients
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of North Carolina
name: Ethan Basch, MD
role: PRINCIPAL_INVESTIGATOR
References: