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LCCC-1231: Observational Longitudinal Study of Pain in Men with Metastatic Castrate-Resistant Prostate Cancer
Protocol Number:
Michael Carducci
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
This is a five-institution multicenter study of patients with metastatic castrate-resistant prostate cancer designed to assess the longitudinal trajectory of pain and other symptoms. The primary outcome is the proportion of pain palliation responders and the proportion experiencing pain progression among patients with metastatic castrate-resistant prostate cancer starting systemic therapy.
The subject must have castration-resistant prostate cancer with metastatic disease involving bone, seen on radiographic imaging and be in a castrate state. The subject must be starting any line treatment post-androgen deprivation/ antiandrogen therapy, such as the following: chemotherapy (e.g., docetaxel, paclitaxel, carboplatin, cabazitaxel, or mitoxantrone); abiraterone acetate; MDV3100; ketoconazole; sipuleucel-T; Radium 223.
This is a single-arm observational longitudinal study in which subjects are followed for up to 26 months. Subjects will complete a short daily diary via an automated phone survey for one week, every six weeks, throughout the study. In each one-week reporting period, study subjects will report pain and analgesic use on a daily basis and will report additional symptoms and the impact of pain on functioning and quality of life on day 7 only. Diagnostic information including: CT of the abdomen/pelvis, bone scans, PSA level, and circulating tumor cells, assessed during the study will be collected from the subjectsâ?? medical records on a quarterly basis. We aim to accrue 500 patients, in which 300 have average worst pain of greater than or equal to 4 at baseline.
Last Update
11/26/2015 05:01 AM

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