Overview

The Role of Androgen Deprivation Treatment (ADT) in Docetaxe-Prednisolone Chemotherapy for Castrate-Resistant Prostatic Cancer

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Asan Medical Center
Treatments:
Androgens
Docetaxel
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
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