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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06100705
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Testosterone Cypionate — DRUG
    Testosterone Cypionate is an androgen and anabolic steroid medication which is used mainly in the treatment of low testosterone levels in men.
  • Sipuleucel-T — DRUG
    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.

Study Details

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).

Key Dates

Start date
Dec 20, 2023
Status verified
Oct 2025
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
26 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Testosterone Cypionate + Sipuleucel-T
    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.

Primary Outcome Measure

To determine the immune response to PA2024 with BAT and Sipuleucel-T [ Time Frame: Through the study completion, average 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale Cancer CenterNew HavenConnecticut06510
Joseph W Kim
[email protected]
12037376467

Find similar trials in New Haven, CT

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Yale Cancer Center· New Haven, CT

Related Studies