Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
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 the Sipuleucel-T vaccine are loaded with) in patients with metastatic castration resistant prostate cancer (mCRPC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 adenocarcinoma of the prostate.
Metastatic disease as evidenced by soft tissue and/or bony metastases on baseline bone scan and/or computed tomography (CT) scan or Magnetic Resonance Image (MRI).
Disqualifiers
PSA >20ng/dL within the 4 weeks prior to signing ICF
Prior chemotherapy for mCRPC. However, prior chemotherapy administered for mCSPC is allowed unless the disease progression to CRPC occurred within 12 months from the last dose of chemotherapy.
Prior treatment with Sipuleucel-T or supraphysiologic dose of testosterone treatment for prostate cancer.
Prior systemic treatment with androgen/Androgen signaling Inhibitor (ASI, e.,g, abiraterone, enzalutamide, apalutamide, darolutamide, or bicalutamide), PARP inhibitor, or Radium-223 or other systemic anti-cancer therapy for prostate cancer within 4 weeks prior to start of treatment.
Trial design
Design model
Single group
Treatments tested in this trial
Testosterone Cypionate
DrugTestosterone Cypionate is an androgen and anabolic steroid medication which is used mainly in the treatment of low testosterone levels in men.
Sipuleucel-T
DrugSipuleucel-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.
Treatment groups
26 Participants
are divided into 1 treatment groupGroup A: Testosterone Cypionate + Sipuleucel-TExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
To determine the immune response to PA2024 with BAT and Sipuleucel-T
As measured by ELISPOT from blood samples in pg/ml
Time frame
Through the study completion, average 12 monthsSecondary outcomes
1
To determine antigen presenting cell (APC) cumulative activation
as assessed by flow cytometry staining and defined as the increase in surface CD54 on APCs, expressed as an upregulation ratio of the average number of molecules on after culture versus before culture cells from the sipuleucel-T product from blood samples in pg/ml
Time frame
Through the study completion, average 12 months2
To determine APC number
as assessed by flow cytometry staining from each sipuleucel-T product. from blood samples in pg/ml
Time frame
Through the study completion, average 12 months3
To determine total nucleated cell count
as assessed by flow cytometry staining from each sipuleucel-T product. from blood samples in pg/ml
Time frame
Through the study completion, average 12 months4
To determine T cell proliferation to PA2024
As measured by ELISPOT from blood samples in pg/ml
Time frame
Through the study completion, average 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
Dendreon
Collaborator
Source ClinicalTrials.gov