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
- 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
- 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
PROJECTED ACCRUAL: A total of 132 patients (66 per treatment arm) will be accrued for this
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
Mitchell Sokoloff, MD, FACS
OHSU Knight Cancer Institute
United States: Federal Government