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.
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.
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
Patients with other (non-adenocarcinoma) biopsy-proven histology of prostate cancer.
Prostate-specific antigen <10 ng/ml.
International Society of Urological Pathology grade group 1.
Clinical T stage T1-T2a digital rectal examination.
Single group
Intraarterial injection of 68Ga-PSMA
Procedure/SurgeryAdditional 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.
Relative increase in intratumoral PSMA uptake after intra-arterial versus intravenous ⁶⁸Ga-PSMA administration
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.
Technical success rate of selective intra-arterial prostate artery catheterization
To evaluate the feasibility and reproducibility of the developed IA delivery protocol by assessing successful selective catheterization of the target prostatic artery and completion of radiotracer administration according to protocol.
Procedural safety of intra-arterial PSMA administration
To assess the safety profile of IA radioligand administration, including procedure-related complications and adverse events. Number, type, and severity of adverse events graded according to CTCAE v5.0; incidence of vascular complications, non-target administration, bleeding, infection, or other procedure-related events
Patient and operator radiation exposure during intra-arterial versus intravenous procedures
To compare the radiation burden associated with IA and IV administration pathways. Absorbed radiation dose (mSv) derived from measurement during and after the procedure.
Identification of PET texture biomarkers associated with optimal tumor saturation
To identify radiomic features predictive of favorable intratumoral radiotracer distribution and complete lesion saturation. Association between extracted texture features and dosimetric endpoints using regression and machine-learning analyses.
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