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NCT07219147 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Stage IVB Prostate Cancer AJCC v8 and Metastatic Castration-Resistant Prostate Adenocarcinoma, sponsored by City of Hope Medical Center.

Recruiting
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT07219147: Recruiting Phase 1 study of Stage IVB Prostate Cancer AJCC v8 and Metastatic Castration-Resistant Prostate Adenocarcinoma, sponsored by City of Hope Medical Center.

NCT07219147 is a Phase 1 study of Stage IVB Prostate Cancer AJCC v8 and Metastatic Castration-Resistant Prostate Adenocarcinoma that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 30 participants, below the 177-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07219147, a Phase 1 study of Stage IVB Prostate Cancer AJCC v8 and Metastatic Castration-Resistant Prostate Adenocarcinoma, is actively recruiting participants, sponsored by City of Hope Medical Center.

RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Will be defined as the proportion of patients with an IgG titer \> 400. Comparisons between study arms will be performed using the Fisher's exact test. Descriptive statistics will be used to summarize the antibody response rates, and Clopper-Pearson exact 95% confidence intervals will be calculated.

Conditions Studied

Stage IVB Prostate Cancer AJCC v8 Metastatic Castration-Resistant Prostate Adenocarcinoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Bone Scan
  • PROCEDURE Leukapheresis
  • DRUG Lutetium Lu 177 Vipivotide Tetraxetan

Study Locations (1)

California

  • City of Hope Medical Center - Duarte

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2026-03-05
Est. Completion 2028-07-26
Phase Phase 1
City of Hope Medical Center

582 total trials

What NCT07219147 shows while recruiting

NCT07219147 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 177-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (83% lower).

The record links to 2 conditions, with Stage IVB Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT07219147 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT07219147 about?

NCT07219147 is a clinical study titled "177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer". 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 (meta...

What is the current status of trial NCT07219147?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2026-03-05. Estimated completion is 2028-07-26.

What conditions does trial NCT07219147 study?

This clinical trial studies the following conditions: Stage IVB Prostate Cancer AJCC v8, Metastatic Castration-Resistant Prostate Adenocarcinoma.

What interventions are being tested in trial NCT07219147?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Bone Scan (PROCEDURE), Leukapheresis (PROCEDURE), Lutetium Lu 177 Vipivotide Tetraxetan (DRUG).

Who is sponsoring clinical trial NCT07219147?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07219147 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Stage IVB Prostate Cancer AJCC v8

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07219147's enrollment target sits among peer trials

30 33rd of 45 higher than 11 of 45 other Stage IVB Prostate Cancer AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stage IVB Prostate Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07219147

Source: ClinicalTrials.gov NCT07219147, the US trial registry maintained by the National Library of Medicine. NCT07219147 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.