A Randomized Phase II Trial of Short Course Androgen Deprivation Therapy With or Without Bevacizumab for Patients With Recurrent Prostate Cancer After Definitive Local Therapy.
PURPOSE Patients with recurrent prostate cancer after local treatment make up a heterogeneous population for whom androgen deprivation therapy (ADT) is the usual treatment. The purpose of this randomized phase II trial was to investigate the efficacy and toxicity of short course ADT with or without bevacizumab in men with hormone sensitive prostate cancer. PATIENTS AND METHODS Eligible patients had an increasing prostate specific antigen (PSA) of 50 ng/mL and PSA doubling time of less than 18 months. Patients had either no metastases or low burden, asymptomatic metastases (lymph nodes 3 cm and five or fewer bone metastases) Patients were randomly assigned 2:1 to a luteinizing hormone releasing hormone agonist, bicalutamide and bevacizumab or ADT alone, for 6 months. The primary end point was PSA relapse free survival (RFS) Relapse was defined as a PSA of more than 0.2 ng/mL for prostatectomy patients or PSA of more than 2.0 ng/mL for primary radiation therapy patients. RESULTS Sixty six patients received ADT bevacizumab and 36 received ADT alone. Patients receiving ADT bevacizumab had a statistically significant improvement in RFS compared with patients treated with ADT alone (13.3 months for ADT bevacizumab v 10.2 months for ADT alone; hazard ratio, 0.47; 95% CI, 0.29 to 0.77; log rank P .002) Hypertension was the most common adverse event in patients receiving ADT bevacizumab (36% CONCLUSION ADT combined with bevacizumab resulted in an improved RFS for patients with hormone sensitive prostate cancer. Long term follow up is needed to determine whether some patients have a durable PSA response and are able to remain off ADT for prolonged periods. Our data provide rationale for combining vascular endothelial growth factor targeting therapy with ADT in hormone sensitive prostate cancer.
Journal of clinical oncology official journal of the American Society of Clinical Oncology