RecruitingPhase 2NCT06100705

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

A Single Arm Open-label, Phase II Study of Sipuleucel-T With Bipolar Androgen Therapy in Men With Metastatic Castration-resistant Prostate Cancer

Sponsor

Yale University

Enrollment

26 participants

Start Date

Dec 20, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Castration-resistant Prostate Cancer

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining sipuleucel-T (a personalized immune therapy vaccine for prostate cancer) with bipolar androgen therapy (BAT — a treatment that rapidly cycles testosterone levels between very high and very low) can improve outcomes for men with metastatic castration-resistant prostate cancer (mCRPC), meaning prostate cancer that has spread and is no longer responding to standard hormone therapy. **You may be eligible if...** - You are a man with a confirmed diagnosis of prostate cancer - Your prostate cancer has spread (metastatic) and is no longer responding to standard testosterone-lowering treatments (castration-resistant) - You meet the FDA-approved criteria for sipuleucel-T: your cancer has few or no symptoms - Your disease is actively progressing (by PSA, measurable disease, or bone/soft tissue growth) - Your testosterone is at castration levels (from ongoing hormonal therapy) - Your overall health is adequate for treatment **You may NOT be eligible if...** - You have significant symptoms from the cancer - You have received prior immunotherapy for prostate cancer - You have severe liver, kidney, or heart conditions - You are on anticoagulant therapy that cannot be safely managed during treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTestosterone Cypionate

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

DRUGSipuleucel-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.