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

Starting soon · Not applicable

Conditions studied: Prostate Cancer, Prostate Adenocarcinoma

In brief

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.

Key facts

Study ID: NCT07656337
Run by: Lithuanian University of Health Sciences
People needed: 10
Starts: 2026-08-01
Expected to finish: 2028-10-31
Last updated by the study team: 2026-06-18

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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.
Systemic therapy-naive patients scheduled for radical prostatectomy with/without pelvic lymph node dissection with curative intent.
High-risk localized or locally-advanced prostate cancer according to European Association of Urology criteria, including one of the following:
Prostate-specific antigen > 20ng/mL2 or ISUP grade 4/5.
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
High PSMA avidity on ⁶⁸Ga-PSMA PET/CT, defined as SUVmax ≥20.
Normal baseline hematological function.
Normal serum biochemistry.
Signed informed consent form.

You may not qualify if…

Patients with other (non-adenocarcinoma) biopsy-proven histology of prostate cancer.
Patients with low-risk prostate cancer according to European Association of Urology criteria, including any of the following:
Prostate-specific antigen <10 ng/ml.
International Society of Urological Pathology grade group 1.
Clinical T stage T1-T2a digital rectal examination.
Prior radiotherapy or systemic therapy for prostate cancer.
Prostate cancer with low PSMA avidity (SUVmax <20) on ⁶⁸Ga-PSMA PET/CT.
Evidence of distant metastatic spread (M1) on ⁶⁸Ga-PSMA PET/CT.
Contraindications for radical prostatectomy.
Major comorbidities and laboratory abnormalities that might confound the results of the trial or interfere with the patient's ability to participate.
Refusal to participate in the trial.

Where it is running

Lithuanian University of Health Sciences Kaunas Clinics — Kaunas, Lithuania

Full record on ClinicalTrials.gov

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