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