NCT02008058

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 213 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Metastatic Castrate-Resistant Prostate Cancer

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2014-01-23
• Primary completion: 2017-03-31
• Completion: 2017-09-30
• First posted: 2013-12-11
• Last updated: 2020-03-30

Locations

4 sites across 1 country: United States