Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06100705
Status:
RECRUITING
Last Update Posted:
2024-01-17
First Post:
2023-10-20
Brief Title:
Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
A Single Arm Open-label Phase II Study of Sipuleucel-T With Bipolar Androgen Therapy in Men With Metastatic Castration-resistant Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
The primary endpoint is the immune response to PA2024 as measured by ELISPOT by week 26 This immunological endpoint was chosen as the primary based on the data showing the Sipuleucel-T immune parameters correlating with overall survival from the pooled analysis phase III trials of Sipuleucel-T Secondary endpoints include other immune parameters related to the Sipuleucel-T including 1 APC cumulative activation CD54 upregulation 2 APC number and 3 total nucleated cells TNC count which also have correlated with survival outcomes and clinical endpoints and 4 T cell proliferation response to PA2024 and PAP 5 ex vivo cytokine profile and 6 humoral response to PA2024 and PAP clinical endpoints including 7 PSA50 response rate PSA50 RR 8 objective response rate ORR 9 radiographic progression-free survival rPFS and 10 overall survival OS 11 safety and tolerability It is hypothesized that BAT potentiates the anti-tumor immune response and enhances clinical outcomes when given before and concurrently with Sipuleucel-T Secondarily it is also hypothesized that the clinical activity of BAT will increase with concurrent Sipuleucel-T as measured by PSA50 response rate and objective response rate compared to historical controls
Participants will start with testosterone injection every 4 weeks The first dose of standard of care Sipuleucel-T will be prepared and infused after two doses of testosterone and will continue every 2 weeks for a total of 3 infusions at a standard schedule The testosterone injection will continue once every 4 weeks until treatment discontinuation criteria are met
The participants will be assessed with HPE and PSA every 4 weeks and radiographic assessment per PCWG3 every 12 weeks DEPO-Testosterone testosterone cypionate IM injection will continue until disease progression unacceptable toxicity or withdrawal of consent to treatment
Participants will start with testosterone injection every 4 weeks The first dose of standard of care Sipuleucel-T will be prepared and infused after two doses of testosterone and will continue every 2 weeks for a total of 3 infusions at a standard schedule The testosterone injection will continue once every 4 weeks until treatment discontinuation criteria are met
The participants will be assessed with HPE and PSA every 4 weeks and radiographic assessment per PCWG3 every 12 weeks DEPO-Testosterone testosterone cypionate IM injection will continue until disease progression unacceptable toxicity or withdrawal of consent to treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None