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

N/ACompletedNCT02008058

UNC Lineberger Comprehensive Cancer Center213 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

213

Conditions

Metastatic Castrate-Resistant Prostate Cancer

Interventions

SurveyBEHAVIORAL

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. Patients will remain on study for up to 26 months (slightly longer than the expected median survival in this population based on data from docetaxel, abiraterone, and MDV3100 pivotal phase 3 trials).

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

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

Outcomes

Primary Outcomes

Proportion of pain palliation responders

Determine the proportion of pain palliation responders and the proportion experiencing pain progression will be presented along with 95% confidence intervals.

Time frame: 6 weeks

Secondary Outcomes

Clinical significance of pain score changes

Determine the clinical significance of pain score changes. Pain score changes will be compared with each of the following "anchors": 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). ROC curves derived using logistic regression analyses will be used to characterize the association between change in pain scores and clinically important improvement (defined by anchor variables).

Time frame: 6 weeks

Prevalence and trajectory of pain progression and pain palliation

Descriptive statistics, including Kaplan-Meier, will be used to report findings for the proportion of asymptomatic men who ultimately develop pain, the median time until asymptomatic men develop pain, the median time until men with pain experience pain progression, and the median time until men with pain experience pain palliation.

Time frame: 3 weeks

Quantifying analgesic medication use

Three different approaches to calculating a single value to represent total analgesic use will be compared: 1) equianalgesic tables published in guidelines of the National Comprehensive Cancer Network (NCCN) which convert various drugs and doses to "morphine equivalents"; 2) point scoring systems used in prior pivotal phase 3 trials based on the World Health Organization analgesic ladder in which lower points are assigned to weaker agents/doses and vice versa for stronger agents/doses; and 3) individual drug dose quantification, a dose recently suggested by the FDA but never empirically evaluated, in which each analgesic is considered individually and a 25% change in dose is considered an increase or decrease for each.

Data from ClinicalTrials.gov

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