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NCT Number: NCT02008058

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.

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Key information

Conditions

Metastatic Castrate-resistant Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Johns Hopkins University, Baltimore, Maryland, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

survey

Behavioral

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

Primary outcomes

  1. Proportion of pain palliation responders

    Time frame: 6 weeks

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

Secondary outcomes

  1. Clinical significance of pain score changes

    Time frame: 6 weeks

    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).

  2. Prevalence and trajectory of pain progression and pain palliation

    Time frame: 3 weeks

    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. Quantifying analgesic medication use

    Time frame: 26 months

    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.

  4. Frequency of pain reporting

    Time frame: 7 days

    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.

  5. Web-avidity of patients

    Time frame: 6 weeks

    Identify the web-avidity of patients by summarizing patients' responses to questionnaire items about their use of internet and email.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • Johns Hopkins University
  • Memorial Sloan Kettering Cancer Center
  • Oregon Health and Science University
  • United States Department of Defense
  • University of Washington

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 11, 2013
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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