A Randomized Phase II Study Of Bone-Targeted Therapy In Advanced Androgen-Dependent Prostate Cancer
- Compare the clinical efficacy of hormonal ablative therapy combined with doxorubicin
and zoledronate with or without strontium chloride Sr 89, in terms of progression-free
survival, in patients with androgen-dependent prostate cancer and bone metastases.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to the
number of bony metastases (≤ 6 versus > 6). Patients are randomized to 1 of 2 treatment
- Arm I: Patients receive hormonal ablative therapy comprising luteinizing
hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during
study treatment OR bilateral orchiectomy. Patients also receive doxorubicin
intravenously (IV) on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV
over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium
chloride Sr 89 IV over 1-2 minutes on day 1.
- Arm II: Patients receive hormonal ablative therapy, doxorubicin, and zoledronate as in
In both arms, treatment continues in the absence of disease progression or unacceptable
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this
study within 20 months.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression
Time to progression defined as the duration of time from start of treatment to disease progression.
4 week intervals, up to 6 months of treatment, then follow up until disease progression
Shi-Ming Tu, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|
|CCOP - Marshfield Clinic Research Foundation||Marshfield, Wisconsin 54449|
|M.D. Anderson Cancer Center at Orlando||Orlando, Florida 32806|