Sipuleucel-T Combined with Bipolar Androgen Therapy in Men with MCRPC

PHASE2RecruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

December 20, 2023

Primary Completion Date

December 31, 2027

Study Completion Date

March 31, 2028

Conditions
Metastatic Castration-resistant Prostate Cancer
Interventions
DRUG

Testosterone Cypionate

Testosterone Cypionate is an androgen and anabolic steroid medication which is used mainly in the treatment of low testosterone levels in men.

DRUG

Sipuleucel-T

Sipuleucel-T is the first FDA-approved immunotherapy in treatment of mCRPC. It is a therapeutic cancer vaccine composed of activated autologous dendritic cells loaded with an engineered fusion protein of prostatic acid phosphatase and granulocyte-macrophage colony-stimulating factor, PAP-GMCSF, also called PA2024. This cellular product is prepared in three steps: (1) leukapheresis to isolate CD54+ dendritic cells, (2) the cells and harvested and cultured with PA2024 ex vivo, and (3) re-infusion of the activated DC into the original patient. The preparation and administration of this autologous cellular product are done every 2 weeks for a total of three infusions and is designed to elicit an immune response to prostatic acid phosphatase.

Trial Locations (1)

06510

RECRUITING

Yale Cancer Center, New Haven

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Dendreon

INDUSTRY

lead

Yale University

OTHER