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

NCT02008058 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 213

Last updated 2020-03-30

No results posted yet for this study

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.

Conditions

  • Metastatic Castrate-Resistant Prostate Cancer

Interventions

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).

Sponsors & Collaborators

Principal Investigators

  • Ethan Basch, MD · University of North Carolina

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-23
Primary Completion
2017-03-31
Completion
2017-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02008058 on ClinicalTrials.gov