Clinical trial · Interventional
Effects of Direct Artery Injection on Prostate Cancer Drug Delivery and Tumor Uptake: Imaging-Based Prediction of Treatment Effectiveness
Impact of Intra-Arterial PSMA Injection on Distribution and Tumor Uptake: Texture Analysis and Dose Radicality Prediction in Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraarterial injection of 68Ga-PSMA | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IA-PSMA
- description
- All enrolled participants receive the same sequence of interventions: * Intravenous 68Ga-PSMA PET/CT * Intra-arterial 68Ga-PSMA PET/CT * Radical prostatectomy (standard of care) Each participant serves as their own control when comparing IV versus IA uptake and distribution.
- interventionNames
- Procedure: Intraarterial injection of 68Ga-PSMA
Primary outcomes (1)
- measure
- Relative increase in intratumoral PSMA uptake after intra-arterial versus intravenous ⁶⁸Ga-PSMA administration
- timeFrame
- Up to 6 weeks from enrollment.
- description
- To determine whether selective intra-arterial (IA) administration of ⁶⁸Ga-PSMA results in superior tumor targeting compared with standard intravenous (IV) administration. Uptake will be quantified using PET/CT-derived parameters, including SUVmax, SUVmean, tumor-to-background ratio (TBR), and volumetric uptake metrics obtained from paired IV and IA scans performed in the same patient.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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: 1. Prostate-specific antigen \> 20ng/mL2 or ISUP grade 4/5. 2. 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 Criteria: * 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: 1. Prostate-specific antigen \<10 ng/ml. 2. International Society of Urological Pathology grade group 1. 3. 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.
References
Publications (0)
Data not yet available