Effects of Direct Artery Injection on Prostate Cancer Drug Delivery and Tumor Uptake: Imaging-Based Prediction of Treatment Effectiveness (IAPSMA)
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
PSMA-targeted radioligands have become an important tool for imaging and treatment of prostate cancer. Intravenous (IV) administration is the current standard route of administration; however, intra-arterial (IA) delivery through the prostatic artery may increase local radioligand concentration within the tumor while reducing systemic distribution.
This prospective, single-center, interventional study aims to evaluate the effect of IA administration of 68Ga-PSMA on tracer distribution and tumor uptake in patients with localized high-risk prostate cancer undergoing radical prostatectomy.
Participants will undergo standard-of-care 68Ga-PSMA PET/CT imaging following intravenous administration and a second PET/CT examination following selective intra-arterial administration of 68Ga-PSMA through the prostatic artery. Quantitative PET/CT analysis will be used to compare tumor uptake, tumor-to-background ratios, and intratumoral distribution between the two administration routes.
The study will also establish and evaluate a standardized technique for selective prostatic artery catheterization and IA radioligand administration. Procedural feasibility, technical success, adverse events, and radiation exposure to patients and medical personnel will be assessed.
Advanced radiomic texture analysis and voxel-based dosimetry will be performed on PET/CT datasets to characterize intratumoral heterogeneity and investigate imaging biomarkers associated with radiotracer distribution. These data will be used to develop predictive models estimating the radiation dose required to achieve a curative ("radical") effect with future 177Lu-PSMA radioligand therapy.
Following imaging, participants will undergo radical prostatectomy according to standard clinical practice. Histopathological findings will be correlated with imaging-derived uptake and texture parameters.
The study is designed to determine whether IA administration improves PSMA uptake and distribution compared with IV administration and to explore imaging-based approaches for personalized radioligand therapy planning in localized prostate cancer.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Donatas Vajauskas, Professor
- Telefonní číslo: +37068750906
- E-mail: donatas.vajauskas@lsmu.lt
Studijní záloha kontaktů
- Jméno: Rūta Dubeikaitė
- Telefonní číslo: +37062266019
- E-mail: ruta.dubeikaite@lsmu.lt
Studijní místa
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Kaunas, Litva, LT-50103
- Lithuanian University of Health Sciences Kaunas Clinics
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Kontakt:
- Administrator
- Telefonní číslo: +3703770337
- E-mail: rastine@kaunoklinikos.lt
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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:
- 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 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:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: IA-PSMA
All enrolled participants receive the same sequence of interventions:
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Additional 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Relative increase in intratumoral PSMA uptake after intra-arterial versus intravenous ⁶⁸Ga-PSMA administration
Časové okno: Up to 6 weeks from enrollment.
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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.
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Up to 6 weeks from enrollment.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Technical success rate of selective intra-arterial prostate artery catheterization
Časové okno: Up to 6 weeks from enrollment.
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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.
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Up to 6 weeks from enrollment.
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Procedural safety of intra-arterial PSMA administration
Časové okno: From IA administration until radical prostatectomy at up to 3 months from enrollment.
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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
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From IA administration until radical prostatectomy at up to 3 months from enrollment.
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Patient and operator radiation exposure during intra-arterial versus intravenous procedures
Časové okno: Up to 6 weeks from enrollment.
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To compare the radiation burden associated with IA and IV administration pathways.
Absorbed radiation dose (mSv) derived from measurement during and after the procedure.
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Up to 6 weeks from enrollment.
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Identification of PET texture biomarkers associated with optimal tumor saturation
Časové okno: Up to 1 year from enrollment.
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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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Up to 1 year from enrollment.
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Predicted absorbed tumor dose achievable with ¹⁷⁷Lu-PSMA therapy
Časové okno: Up to 1 year from enrollment.
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To estimate the radiation dose that would be delivered to tumor tissue during therapeutic ¹⁷⁷Lu-PSMA administration based on diagnostic PET-derived biodistribution.
Voxel-based absorbed dose estimates (Gy) and dose-volume histogram parameters.
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Up to 1 year from enrollment.
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- PSMA 1.0
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Typ podpůrných informací pro sdílení IPD
- ICF
- CSR
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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Klinické studie na Intraarterial injection of 68Ga-PSMA
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Maltepe UniversityThe Scientific and Technological Research Council of TurkeyDokončenoGamifikace | Intramuskulární injekce | Studenti, Ošetřovatelství | Video-Based LearningTurecko (Türkiye)