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Prostate cancer imaging gets a direct hit: artery injection may sharpen scans

NCT ID NCT07656337

Knowledge-focused Sponsor: Lithuanian University of Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether injecting a radioactive tracer directly into the prostate artery improves imaging compared to standard arm injection in 10 men with high-risk prostate cancer. The goal is to see if this method gives clearer pictures and helps predict the right radiation dose for future treatments. Participants will have two scans and then proceed with standard surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
68Ga-PSMA
What this could lead to
If successful, this could lead to more precise imaging and personalized radiation dosing for prostate cancer treatment.
What could go wrong
This is a very small, early-phase study with only 10 participants, so results may not apply broadly. The intra-arterial procedure carries additional risks like bleeding or vessel damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate adenocarcinoma Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, LT-50103, Lithuania

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