Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT02008058
Eligibility 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 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.
* 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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02008058
Study Brief:
Protocol Section:
NCT02008058