A Single Arm Open-label, Phase II Study of Sipuleucel-T With Bipolar Androgen Therapy in Men With Metastatic Castration-resistant Prostate Cancer
Volunteers
Health Professionals
What is the purpose of this trial?
This is an open-label, single-arm phase II study of bipolar androgen therapy (BAT) given in addition with standard of care Sipuleucel-T to determine the interferon (IFN) gamma Enzyme-linked Immunospot (ELISPOT) response rate to PA2024 (an engineered fusion protein of prostatic acid phosphatase and granulocyte-macrophage colony-stimulating factor which the activated autologous dendritic cells in the Sipuleucel-T vaccine are loaded with) in patients with metastatic castration resistant prostate cancer (mCRPC).
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Principal Investigator
Sub-Investigators
- Agatha Hecht
- Alessia Donadio, MD
- Alison Johnson
- Anca Bulgaru, MD
- Andrea Brennan
- Armand Russo, MD
- Benjamin Newton, MD
- Beverly Drucker, MD, PhD
- Christi Kim, MD, FACP
- D. Barry Boyd, MD, MS
- Daniel P. Petrylak, MD
- Elan Gorshein, DO, JD, MPH
- Emily Kopas, APRN, OCN
- Harold Tara Jr, MD
- Isaac Y. Kim, MD, PhD, MBA
- Jade Vanacore
- James Vredenburgh, MD
- Jason Haldas, MD
- Jeremy Kortmansky, MD
- Jose Morales-Marin
- Karishma Mehra, MBBS
- Kristen Hoxie
- Larisa Fleysher
- Laura Sabourin
- M. Sung Lee, MD
- Madeleine Wood
- Madeline Santiago
- Matthew Austin, MD
- Michael Hurwitz, MD, PhD
- Michelle Laspino
- Neal Fischbach, MD
- Pawan Karanam, MD
- Rebecca Vanasse-Passas, MD
- Renee Moye
- Robert Legare, MD
- Sara Anastasio, RN
- Sarah Carlson
- Stephen Lattanzi, MD
- Su Hsien Lim, MD
- Vidya Kesavan
- Virginia Syombathy
- Wajih Kidwai, MD, FACP
- Yifei Zhang, MD
- Zia Rahman, MD
- Last Updated08/07/2024
- Study HIC#2000035188