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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborators:
Oregon Health and Science University
Johns Hopkins University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01617174
First received: June 8, 2012
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Prostate Cancer
Behavioral: Webcore telephone survey system

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • pain score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617174

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Oregon Health and Science University
Johns Hopkins University
Investigators
Principal Investigator: Michael Morris, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01617174     History of Changes
Other Study ID Numbers: 12-110
Study First Received: June 8, 2012
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
prostate
pain assessment
12-110

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 30, 2014