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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Castrate-Resistant Prostate Cancer
• Intervention / Treatment: Behavioral: Survey

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).

• Study Type: Observational
• Enrollment (Actual): 213

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Johns Hopkins University
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Lineberger Comprehensive Cancer Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Washington
    • Seattle, Washington, United States, 98109
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Oncology clinic

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Single Arm; Surveys, diaries, clinical assessments of men with metastatic castrate-resistant prostate cancer

Behavioral: Survey; 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).; Other Names: Webcore telephone survey system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	26 months
Frequency of pain reporting	Seven consecutive days of reporting a pain item with a 24-hour recall item will be compared with a single administration of a pain item with a 7-day recall, in order to evaluate if the latter alone is sufficient for measuring pain.	7 days
Web-avidity of patients	Identify the web-avidity of patients by summarizing patients' responses to questionnaire items about their use of internet and email.	6 weeks

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: Johns Hopkins University; Memorial Sloan Kettering Cancer Center; United States Department of Defense; Oregon Health and Science University; University of Washington
• Investigators: Principal Investigator: Ethan Basch, MD, University of North Carolina

Publications and helpful links

Helpful Links

• Lineberger Comprehensive Cancer Center website
• National Cancer Institute (NCI) website

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 23, 2014
• Primary Completion (ACTUAL): March 31, 2017
• Study Completion (ACTUAL): September 30, 2017

Study Registration Dates

• First Submitted: December 6, 2013
• First Submitted That Met QC Criteria: December 6, 2013
• First Posted (ESTIMATE): December 11, 2013

Study Record Updates

• Last Update Posted (ACTUAL): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 27, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Pain; Prostate Cancer; Lineberger Comprehensive Cancer Center; UNC Lineberger; Metastatic Castrate-Resistant Prostate Cancer; LCCC 1231
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: LCCC 1231; 12-2562 (OTHER: UNC IRB)