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This study has been withdrawn prior to enrollment.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

June 8, 2012
November 6, 2013
June 2012
June 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01617174 on ClinicalTrials.gov Archive Site
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Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer
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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

Prostate Cancer
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.
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.
Intervention: Behavioral: Webcore telephone survey system
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2014
June 2014   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT01617174
12-110
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Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • Oregon Health and Science University
  • Johns Hopkins University
Principal Investigator: Michael Morris, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP