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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01617174
• Other study ID #: 12-110
• Status: Withdrawn
• Phase: N/A
• First received: June 8, 2012
• Last updated: November 6, 2013
• Start date: June 2012
• Est. completion date: June 2014

Study information

• Verified date: November 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The first goal of this study is to learn more about the experience of pain and other symptoms in men being treated for advanced prostate cancer. The second goal of the study is to identify reliable ways of measuring pain which will be used in future clinical trials of treatments for advanced prostate cancer.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• 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 of systemic treatment post-androgen deprivation/antiandrogen therapy, with any of the following: chemotherapy (e.g., docetaxel, paclitaxel, carboplatin, cabazitaxel, or mitoxantrone); abiraterone acetate; MDV3100; ketoconazole; a clinical trial.

• 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Webcore telephone survey system
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Johns Hopkins University, Oregon Health and Science University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score	Pain score changes will be correlated with each of the following: 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). The distribution-based approach is to estimate meaningful change as one-half a standard deviation of the sample mean pain score.	2 years	No

External Links

•   Memorial Sloan-Kettering Cancer Center