“Fighting Cancer: It’s All We Do.” ™. Therapies in Androgen Resistant Prostate cancer and non metastatic prostate cancer. Ulka Vaishampayan M.D. Chair, GU Multidisciplinary team Associate Professor Of Medicine Detroit Medical Center
Ulka Vaishampayan M.D.
Chair, GU Multidisciplinary team
Associate Professor Of Medicine
Detroit Medical Center
Wayne State University/ Karmanos Cancer Institute, Detroit MI.
Eisenberger et al. ASCO 2004, abstr#4
De Wit et al. Presented at the Annual Meeting of the American Society for Clinical Oncology, 2004. Plenary Session [abstract 4]
Eisenberger MA et al. J Clin Oncol. 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition). Vol 22, No 14S (July 15 suppl), 2004:4 [Kathy to style refs]
Novel hormone agents: abiraterone, Kinex, TAK-700
Androgen receptor blockers- MDV-3100
Integrin inhibitors: EMD525797
Penson et al.
IMPACT Study Investigators
American Urological Association Annual Meeting
April 28, 2009
P R O G R E S S I O N
Treated at Physician discretion
Sipuleucel-T Q 2 weeks x 3
Asymptomatic or Minimally Symptomatic Metastatic
Prostate Cancer (N=512)
Treated at Physician discretion and/or Salvage Protocol
Placebo Q 2 weeks x 3
Primary endpoint: Overall Survival
Secondary endpoint: Time to Objective Disease
sipuleucel-T is manufactured
Patient is infused
COMPLETE COURSE OF THERAPY:
Weeks 0, 2, 4
First active immunotherapy to demonstrate improvement in overall survival for prostate cancer
Favorable benefit to risk profile
Short duration of therapy
Problems: Compared to placebo and not to chemotherapy, (docetaxel was compared to mitoxantrone). Easier to show benefit.
Fairly cumbersome, with pheresis.
No data regarding palliation, and worrisome that no improvement in time to objective progression.
Represents another therapy in the armamentarium against prostate cancer.
Chen, Clegg and Scher
Primary Endpoint: 25% survival increase (12 to 15 months)
Sample size: ~1170 (780 and 390)
Statistics: 85% Power; p=0.05, two-sided
Scher, H. (North America) and De Bono, J. Co-PI, Medivation
No standard approved therapy
Clinical trials offer the best therapy in this setting.
Consider very carefully the risks vs benefits
Moul et al. Urologic Oncology:Sem and Original Investigations, 21; 292-304, 2003