An Open Label Randomized Phase 2 Study To Evaluate The Activity, Tolerability, And Toxicity Of Combined Neoadjuvant Anti-angiogenesis and Androgen Ablation Therapy in Men Undergoing Radical Prostatectomy
OBJECTIVES:
- Compare the effect of neoadjuvant androgen-ablation therapy with vs without squalamine
lactate on induced tumor regression and grade migration in patients with locally
advanced high-risk adenocarcinoma of the prostate undergoing a radical prostatectomy.
- Compare the duration of clinical disease-free survival of patients treated with these
regimens.
- Determine the applicability of prostate-specific antigen (PSA) serology as an endpoint
determinant in patients treated with these regimens.
- Compare the feasibility and potential safety effects on wound healing and recovery in
patients treated with these regimens before and after a radical prostatectomy.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive leuprolide intramuscularly once a month for 3 months and oral
bicalutamide once a day for 2 weeks.
- Arm II: Patients receive leuprolide and bicalutamide as in arm I plus squalamine
lactate IV over 4 hours once weekly for 6 weeks.
Seven weeks after beginning treatment, patients in both arms undergo standard radical
prostatectomy. Patients then continue to receive leuprolide and bicalutamide with or without
squalamine lactate for up to 6 additional weeks.
After completion of study treatment, patients are followed periodically for at least 3
years.
PROJECTED ACCRUAL: A total of 132 patients (66 per treatment arm) will be accrued for this
study.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Tumor response in terms of tumor volume as measured by transrectal ultrasound before and after neoadjuvant treatment
No
Mitchell Sokoloff, MD, FACS
Study Chair
OHSU Knight Cancer Institute
United States: Federal Government
CDR0000446087
NCT00244920
January 2002
June 2007
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