Status:
UNKNOWN
The Role of Androgen Deprivation Treatment (ADT) in Docetaxe-Prednisolone Chemotherapy for Castrate-Resistant Prostatic Cancer
Lead Sponsor:
Asan Medical Center
Conditions:
Castration-resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the androgen deprivation therapy when patients with castration-resistant prostate cancer are treated with docetaxel-based chemotherapy.
Detailed Description
Androgen deprivation therapy (ADT) has been the mainstay in the treatment of metastatic prostate carcinoma. Despite initial favorable responses, predictable and irreversible resistance to ADT will occ...
Eligibility Criteria
Inclusion
- 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
- Other tumor type than adenocarcinoma
- Presence or history of CNS metastasis
- Other serious illness or medical conditions
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01487902
Start Date
July 1 2010
Last Update
December 8 2011
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736