Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC

Recruiting Phase 2 Interventional Study
Metastatic Castration-resistant Prostate Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
26 (estimated)
Sponsor
Yale University · Other
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About 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 th…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Written informed consent obtained prior to the initiation of study procedures. * Patients who meet the US FDA-approved indication for Sipuleucel-T: for asymptomatic or minimally symptomatic mCRPC at the discretion of the treating investigator. * Histologically confirmed adenoc…
Contacts

Laura Kane

7733696904

Laura.Kane@yale.edu

CONTACT