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NOT YET RECRUITING
NCT07656337
NA

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

Sponsor: Lithuanian University of Health Sciences

View on ClinicalTrials.gov

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.

Official title: Impact of Intra-Arterial PSMA Injection on Distribution and Tumor Uptake: Texture Analysis and Dose Radicality Prediction in Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-08-01

Completion Date

2028-10-31

Last Updated

2026-06-18

Healthy Volunteers

No

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.

Locations (1)

Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, Lithuania