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


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

pain score

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Michael Morris, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

12-110

NCT ID:

NCT01617174

Start Date:

June 2012

Completion Date:

June 2014

Related Keywords:

  • Prostate Cancer
  • prostate
  • pain assessment
  • 12-110
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Oregon Health & Science UniversityPortland, Oregon  97201
John Hopkins Medical CenterBaltimore, Maryland  21287