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

Metastatic Castrate-Resistant Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008058
• Other study ID #: LCCC 1231
• Secondary ID: 12-2562
• Status: Completed
• Start date: January 23, 2014
• Est. completion date: September 30, 2017

Study information

• Verified date: April 2019
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: September 30, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Castrate-Resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

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).

Locations

Country	Name	City	State
United States	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

Sponsors (6)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	Johns Hopkins University, Memorial Sloan Kettering Cancer Center, Oregon Health and Science University, United States Department of Defense, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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