Prostate CancerIAPSMANCT07656337
Effects of Direct Artery Injection on Prostate Cancer Drug Delivery and Tumor Uptake: Imaging-Based Prediction of Treatment Effectiveness
A study testing Intraarterial injection of 68Ga-PSMA in people with Prostate Cancer and Prostate Adenocarcinoma, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma
- What is being tested?
- Intraarterial injection of 68Ga-PSMA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Aug 2026to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Normal baseline hematological function.
- Normal serum biochemistry.
- Signed informed consent form.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lithuania1 site
Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, LT-50103
Administrator, +3703770337, rastine@kaunoklinikos.lt
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Being tested
- Intraarterial injection of 68Ga-PSMA
- Keywords
- Prostate cancer, Intraarterial PSMA injection, Texture analysis, Dose radicality prediction
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraarterial injection of 68Ga-PSMAProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Intraarterial injection of 68Ga-PSMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 weeks from enrollment.
Secondary outcomes (5)
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.
Measured: Up to 6 weeks from enrollment.
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
Measured: From IA administration until radical prostatectomy at up to 3 months from enrollment.
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.
Measured: Up to 6 weeks from enrollment.
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.
Measured: Up to 1 year from enrollment.
Predicted absorbed tumor dose achievable with ¹⁷⁷Lu-PSMA therapy
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.
Measured: Up to 1 year from enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rūta Dubeikaitė, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656337
- Sponsor's protocol ID
- PSMA 1.0
- Acronym
- IAPSMA
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publications.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intra-Arterial PSMA Injection on Distribution and Tumor Uptake: Texture Analysis and Dose Radicality Prediction in Prostate Cancer
- ClinicalTrials.gov ID
- NCT07656337
- Acronym / sponsor ID
- IAPSMA / PSMA 1.0
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Keywords
- Prostate cancer, Intraarterial PSMA injection, Texture analysis, Dose radicality prediction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IA-PSMA | Experimental | Procedure: Intraarterial injection of 68Ga-PSMAAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- High PSMA avidity on ⁶⁸Ga-PSMA PET/CT, defined as SUVmax ≥20.
- Normal baseline hematological function.
Key exclusion criteria (11 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraarterial injection of 68Ga-PSMAAdditional 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. | Procedure or surgery | IA-PSMA |
Primary outcome
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.
5 secondary outcomes
Technical success rate of selective intra-arterial prostate artery catheterization
Time frame: 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.
Patient and operator radiation exposure during intra-arterial versus intravenous procedures
Time frame: Up to 6 weeks from enrollment.
Identification of PET texture biomarkers associated with optimal tumor saturation
Time frame: Up to 1 year from enrollment.
Predicted absorbed tumor dose achievable with ¹⁷⁷Lu-PSMA therapy
Time frame: Up to 1 year from enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraarterial injection of 68Ga-PSMA in people with Prostate Cancer and Prostate Adenocarcinoma, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donatas Vajauskas, Professor (+37068750906, donatas.vajauskas@lsmu.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative increase in intratumoral PSMA uptake after intra-arterial versus intravenous ⁶⁸Ga-PSMA administration (time frame: Up to 6 weeks from enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.