RecruitingPhase 1NCT07219147

177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Pilot Study of ¹⁷⁷Lu-PSMA-617 in Combination With Sipuleucel-T in Patients With Metastatic Castration-Resistant Prostate Cancer


Sponsor

City of Hope Medical Center

Enrollment

30 participants

Start Date

Mar 6, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial compares the effect of lutetium Lu 177 (177\^Lu)-prostate-specific membrane antigen (PSMA)-617 in combination with Sipuleucel-T to 177\^Lu-PSMA-617 alone in treating patients with prostate that has spread from where it first started (primary site) to other places in the body (metastatic) and has continued to grow and spread despite surgical or medical intervention to block androgen production (castration-resistant). 177\^Lu-PSMA-617, a type of radioconjugate, binds to a protein called PSMA, which is found on some prostate tumor cells. It gives off radiation that may kill the tumor cells. Sipuleucel-T, a type of vaccine and a type of cellular adoptive immunotherapy, is made from immune system cells. The cells are treated with a protein that is made by combining a protein found on prostate tumor cells with a growth factor. When the cells are injected back into the patient, they may stimulate T cells to kill prostate tumor cells. Giving 177\^Lu-PSMA-617 in combination with sipuleucel-T may be safe, tolerable, and/or effective compared to 177\^Lu-PSMA-617 alone in treating patients with metastatic castration-resistant prostate cancer.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining two types of cancer treatments — lutetium-177 PSMA-617 (a radioactive drug that targets prostate cancer cells) and sipuleucel-T (a personalized immune therapy) — can improve outcomes for men with metastatic castration-resistant prostate cancer (mCRPC), meaning prostate cancer that has spread and no longer responds to hormone therapy. **You may be eligible if...** - You are a man aged 18 or older with confirmed prostate cancer that has spread and is no longer responding to hormone therapy - Your cancer has been confirmed by biopsy as adenocarcinoma (not small cell) - You are generally well enough for cancer treatment (ECOG score of 0 or 1) - You have measurable or non-measurable disease on scans - You agree to allow use of archived tumor tissue **You may NOT be eligible if...** - Your cancer is the small cell type - You are not able to tolerate the treatment due to poor health status - You do not have adequate organ function 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

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Scan

Undergo bone scan

PROCEDUREComputed Tomography

Undergo CT and PSMA PET/CT

PROCEDURELeukapheresis

Undergo leukapheresis

DRUGLutetium Lu 177 Vipivotide Tetraxetan

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPSMA PET Scan

Undergo PSMA PET/CT

BIOLOGICALSipuleucel-T

Given IV


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT07219147


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