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Effects of Direct Artery Injection on Prostate Cancer Drug Delivery and Tumor Uptake: Imaging-Based Prediction of Treatment Effectiveness

NCT07656337 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-06-18

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether intra-arterial (IA) administration of 68Ga-PSMA improves tumor uptake and distribution compared with standard intravenous (IV) administration in patients with localized high-risk prostate cancer. The study will also evaluate the safety of the IA procedure and investigate whether advanced PET/CT imaging features can help predict the radiation dose needed for future personalized 177Lu-PSMA radioligand therapy.

The main questions it aims to answer are:

* Does intra-arterial 68Ga-PSMA administration result in higher and more homogeneous tumor uptake than standard intravenous administration?
* Can PET/CT texture analysis and dosimetric modeling predict the radiation dose required to achieve a curative effect with 177Lu-PSMA therapy?
* What radiation exposure and procedure-related risks are associated with intra-arterial administration for patients and medical staff?

Researchers will compare PSMA uptake and distribution after intravenous and intra-arterial administration of 68Ga-PSMA using PET/CT imaging.

Participants will:

* Undergo a standard intravenous 68Ga-PSMA PET/CT scan.
* Undergo a second 68Ga-PSMA PET/CT scan following selective intra-arterial administration through the prostatic artery.
* Have imaging data analyzed using advanced texture analysis and voxel-based dosimetry methods.
* Undergo radical prostatectomy according to standard clinical care, with pathological analysis of surgical specimens.
* Be monitored for adverse events, radiation exposure, and procedural safety throughout the study.

Conditions

Interventions

PROCEDURE

Intraarterial injection of 68Ga-PSMA

Additional intervention to the standard of care for prostate cancer treatment - prostate artery catheterization and intra-arterial injection of 68Ga-PSMA with subsequent PET/CT scan.

Sponsors & Collaborators

  • Lithuanian University of Health Sciences

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-01-31
Completion
2028-10-31

Countries

  • Lithuania

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07656337 on ClinicalTrials.gov