Effects of Direct Artery Injection on Prostate Cancer Drug Delivery and Tumor Uptake: Imaging-Based Prediction of Treatment Effectiveness
Key facts
- Where
- Kaunas, LithuaniaSee the site
Where in Lithuania
- Lithuanian University of Health Sciences Kaunas ClinicsKaunas, LithuaniaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Lithuanian University of Health Sciences
- Trial code
- NCT07656337
- Record updated
- 18 June 2026
- Original description
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.Read full original descriptionShow less
Impact of Intra-Arterial PSMA Injection on Distribution and Tumor Uptake: Texture Analysis and Dose Radicality Prediction in Prostate Cancer
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.
Inclusion: 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.
Exclusion: Prior radiotherapy or systemic therapy for prostate cancer; 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; Prostate cancer with low PSMA avidity (SUVmax <20) on ⁶⁸Ga-PSMA PET/CT; Major comorbidities and laboratory abnormalities that might confound the results of the trial or interfere with the patient's ability to participate; Evidence of distant metastatic spread (M1) on ⁶⁸Ga-PSMA PET/CT; Contraindications for radical prostatectomy; Refusal to participate in the trial.