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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT01487902
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Clinical or radiologic evidence of metastatic disease
* Documented disease progression during hormone therapy (ADT with or without antiandrogen)
* Cessation of ADT at least 4 weeks in non-orchiectomized patients
* Adequate duration (at least 4 weeks for flutamide and 6 weeks for bicalutamide) of anti-androgen withdrawal (only for patients who showed a response or decline in PSA for more than 3 months)
* KPS ≥ 60
* No prior cyto-toxic chemotherapy (except estramustine) or radioisotopes
* No prior radiotherapy 25% or more of the bone marrow
* No peripheral neuropathy grade 2 or worse
* Adequate organ and bone marrow function
Exclusion Criteria:
* Other tumor type than adenocarcinoma
* Presence or history of CNS metastasis
* Other serious illness or medical conditions
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01487902
Study Brief:
Protocol Section:
NCT01487902