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

15. Juni 2026 aktualisiert von: Rūta Dubeikaitė, Lithuanian University of Health Sciences

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

10

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Litauen
      • Kaunas, Litauen, LT-50103
        • Lithuanian University of Health Sciences Kaunas Clinics
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: IA-PSMA

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.
Verfahren: Intraarterial injection of 68Ga-PSMA
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Relative increase in intratumoral PSMA uptake after intra-arterial versus intravenous ⁶⁸Ga-PSMA administration
Zeitfenster: Up to 6 weeks from enrollment.
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.
Up to 6 weeks from enrollment.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Technical success rate of selective intra-arterial prostate artery catheterization
Zeitfenster: Up to 6 weeks from enrollment.
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.
Up to 6 weeks from enrollment.
Procedural safety of intra-arterial PSMA administration
Zeitfenster: From IA administration until radical prostatectomy at up to 3 months from enrollment.
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
From IA administration until radical prostatectomy at up to 3 months from enrollment.
Patient and operator radiation exposure during intra-arterial versus intravenous procedures
Zeitfenster: Up to 6 weeks from enrollment.
To compare the radiation burden associated with IA and IV administration pathways. Absorbed radiation dose (mSv) derived from measurement during and after the procedure.
Up to 6 weeks from enrollment.
Identification of PET texture biomarkers associated with optimal tumor saturation
Zeitfenster: Up to 1 year from enrollment.
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.
Up to 1 year from enrollment.
Predicted absorbed tumor dose achievable with ¹⁷⁷Lu-PSMA therapy
Zeitfenster: Up to 1 year from enrollment.
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.
Up to 1 year from enrollment.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Lithuanian University of Health Sciences

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

31. Januar 2028

Studienabschluss (Geschätzt)

31. Oktober 2028

Studienanmeldedaten

Zuerst eingereicht

4. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Juni 2026

Zuerst gepostet (Tatsächlich)

18. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PSMA 1.0

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Only IPD used in the results publications.

IPD-Sharing-Zeitrahmen

Beginning 3 months and ending 1 year after the publication of results.

Art der unterstützenden IPD-Freigabeinformationen

  • ICF
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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