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

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.

Study Overview

• Status: Withdrawn
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Webcore telephone survey system

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will be recruited from 3 different collaborating sites: MSKCC, John Hopkins, and OHSU. MSKCC will enroll approximately 200 patients, and John Hopkins and OHSU will each enroll approximately 100 patients; 400 participants will be enrolled in total. MSKCC is the coordinating site for this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

assessments completed by patients; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Johns Hopkins University; Oregon Health and Science University

Publications and helpful links

Helpful Links

• Memorial Sloan-Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: June 8, 2012
• First Submitted That Met QC Criteria: June 8, 2012
• First Posted (Estimate): June 12, 2012

Study Record Updates

• Last Update Posted (Estimate): November 8, 2013
• Last Update Submitted That Met QC Criteria: November 6, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: pain assessment; prostate; 12-110
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 12-110 (University of Pittsburgh Cancer Institute)