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

June 15, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Lithuania
      • Kaunas, Lithuania, LT-50103
        • Lithuanian University of Health Sciences Kaunas Clinics
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Relative increase in intratumoral PSMA uptake after intra-arterial versus intravenous ⁶⁸Ga-PSMA administration
Time Frame: 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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technical success rate of selective intra-arterial prostate artery catheterization
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lithuanian University of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PSMA 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Only IPD used in the results publications.

IPD Sharing Time Frame

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

IPD Sharing Supporting Information Type

  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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