Hormone Therapy Plus Chemotherapy as Initial Treatment for Local Failures or Advanced Prostate Cancer
Status:
Terminated
Trial end date:
2017-09-14
Target enrollment:
Participant gender:
Summary
This study is for men who have prostate cancer and have failed local therapy or are not a
candidate for prostatectomy or radiation therapy. The purpose of this research study is to
assess the safety and benefit of androgen deprivation therapy (ADT, blocks hormones) plus
chemotherapy. Degarelix is the hormone blocking drug that will be used. Doxorubicin,
Ketoconazole, Docetaxel and Estramustine are the chemotherapy drugs that will be used. The
drugs used in this study are approved by the Food and Drug Administration (FDA).
Participants will be treated with ADT plus chemotherapy for three, four, or five 8-week
cycles (12, 18, or 24 months). The number of cycles of chemotherapy they receive and the
number of months they receive ADT will be based on their disease. The current standard
treatment is ADT and chemotherapy. What differs in this research study is the cycling and
combination of chemotherapy drugs chosen. The drugs chosen for this study have fewer side
effects and are believed to provide maximum benefit.
Phase:
Phase 2
Details
Lead Sponsor:
The University of Texas Health Science Center, Houston