TheranosticTrials.org

Clinical Trial · NCT07656337

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

Overview

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.

Sponsor

Norwegian University of Science and Technology

Phase

N/A

Contacts

Rūta Dubeikaitė (CONTACT)

ruta.dubeikaite@lsmu.lt

+37062266019

Donatas Vajauskas, Professor (CONTACT)

donatas.vajauskas@lsmu.lt

+37068750906

ClinicalTrials.gov

NCT07656337

Drug / Compound

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

PSMA-617

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • Clinical T stage cT3-4\* and/or N1 disease (involvement of lymph nodes at or below the bifurcation of the common iliac arteries), any ISUP grade, and any
  • Systemic therapy-naive patients scheduled for radical prostatectomy with/without pelvic lymph node dissection with curative intent.
  • * Adult male patients with biopsy-proven prostate adenocarcinoma up to stages ≤T3bN1 by initial preoperative examination, with no distant metastases (M0) on ⁶⁸Ga-PSMA PET/CT.
  • Prostate-specific antigen \> 20ng/mL2 or ISUP grade 4/5.
  • High-risk localized or locally-advanced prostate cancer according to European Association of Urology criteria, including one of the following:

Exclusion

  • * Patients with other (non-adenocarcinoma) biopsy-proven histology of prostate cancer.
  • Prostate-specific antigen \<10 ng/ml.
  • Clinical T stage T1-T2a digital rectal examination.
  • International Society of Urological Pathology grade group 1.
  • Patients with low-risk prostate cancer according to European Association of Urology criteria, including any of the following: