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

NCT07656337 | Not Yet Recruiting

• 1 other identifier: PSMA 1.0
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer; Prostate Adenocarcinoma

Keywords

Prostate cancer; Intraarterial PSMA injection; Texture analysis; Dose radicality prediction

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 6 weeks from enrollment.

Secondary Outcomes (5)

• Technical success rate of selective intra-arterial prostate artery catheterization

  Up to 6 weeks from enrollment.

• Procedural safety of intra-arterial PSMA administration

  From IA administration until radical prostatectomy at up to 3 months from enrollment.

• Patient and operator radiation exposure during intra-arterial versus intravenous procedures

  Up to 6 weeks from enrollment.

• Identification of PET texture biomarkers associated with optimal tumor saturation

  Up to 1 year from enrollment.

• Predicted absorbed tumor dose achievable with ¹⁷⁷Lu-PSMA therapy

  Up to 1 year from enrollment.

Study Arms (1)

IA-PSMA

EXPERIMENTAL

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.

Procedure: Intraarterial injection of 68Ga-PSMA

Interventions

Intraarterial injection of 68Ga-PSMA PROCEDURE

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.

IA-PSMA

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only male patients are eligible for participation due to the object of the study being prostate cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, LT-50103, Lithuania

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Donatas Vajauskas, Professor

CONTACT

+37068750906; donatas.vajauskas@lsmu.lt

Rūta Dubeikaitė

CONTACT

+37062266019; ruta.dubeikaite@lsmu.lt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 18, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: Beginning 3 months and ending 1 year after the publication of results.

Locations

LI (1)