Finding studies
Finding studies
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Lead
OHSU Knight Cancer Institute
With
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.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted