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

Withdrawn

• Conditions: Prostate Cancer
• Interventions: Behavioral: Webcore telephone survey system

• Registration Number: NCT01617174
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-08
• Study First Submitted QC: 2012-06-08
• Study First Posted: 2012-06-12
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-06
• Last Update Posted: 2013-11-08
• Primary Completion: 2014-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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.

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Exclusion Criteria

• The subject has small cell or predominantly neuroendocrine differentiated prostate tumor.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
assessments completed by patients	Webcore telephone survey system	A single-arm observational study will be conducted at three institutions in the Prostate Cancer Clinical Trials Consortium (PCCTC): Memorial Sloan-Kettering Cancer Center; Johns Hopkins; and Oregon Health \& Science University. MSKCC is the coordinating center. The target enrollment is 400 patients, with at least 250 experiencing "moderate or worse" pain intensity at baseline, defined as a score of ≥4, the preferred regulatory cutoff.

Primary Outcome Measures

Name	Time	Method
pain score	2 years	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.