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New scan could spot prostate cancer more accurately

NCT ID NCT05847166

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new radioactive imaging agent called PSMA-T4 to see if it can safely and accurately find prostate cancer tumors. About 80 men with prostate cancer will receive an injection of PSMA-T4 and then have a special scan (SPECT/CT) to detect cancer lesions. The goal is to improve diagnosis and treatment planning by comparing this new method with standard imaging techniques.

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 80 people

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

Started

May 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. 18 years of age or older. 2. PS ECOG \< 2 3. Prior diagnosis of any type of prostate cancer with a Gleason score (GlS) above 6. 4. Confirmatory prostate biopsy within 12 weeks (time from pathological diagnosis as PCA date of pathological description to the time of signing the patient's informed consent to participate in the study), only for cohorts A and B. 5. Pelvic mpMRI prostate with PIRADS 2.1 score within 12 weeks before screening, only for cohorts A and B. 6. Willingness to participate in this study and to provide written informed consent. Additional inclusion criteria for each cohort: Cohort A: 1. Intermediate risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer 2. Greater than 10% chance of lymph node involvement assessed using the Memorial Sloan Kettering nomogram for probability of lymph node involvement in prostate cancer patients. 3. CT of the chest, abdomen and pelvis and bone scan within 12 weeks before screening in the unfavorable risk PC subgroup. 4. No prior treatment for prostate cancer. Cohort B: 1. High or very high-risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer 2. CT of the chest, abdomen and pelvis and bone scan within 12 weeks before screening in the unfavorable risk PC subgroup. 3. No prior treatment for prostate cancer. Cohort C: Biochemical failure after radical prostatectomy defined as failure of PSA to fall to undetectable levels (PSA persistence) or undetectable PSA after radical prostatectomy with a subsequent detectable PSA that increases on 2 or more determinations (PSA recurrence) OR biochemical failure after definitive radiotherapy based on Phoenix Consensus (a rise by 2 ng/mL or more above the nadir PSA) OR radiographic evidence of metastatic disease without PSA persistence/recurrence OR clinical symptoms suggesting distant metastases (Roach et al.., 2006). Exclusion Criteria: 1. No histopathological confirmation of prostate cancer. 2. Patients with pacemakers or metal parts that prevent pelvic MRI to confirm the presence of prostate cancer. 3. Abnormal liver function including a significant increase of liver enzymes like: ALAT, ASPAT, alkaline phosphatase (AP) greater than 5x upper limit normal (ULN) and an increase in bilirubin greater than 2x ULN. 4. Renal impairment including eGFR \<30 ml / min. 5. Within 6 months before inclusion into the study: myocardial infarction, other cardiac events requiring hospitalization (unstable angina, etc.), cerebrovascular accident, transient ischemic attack, acute stroke, pulmonary embolism or deep vein thrombosis 6. Acute congestive heart failure or severe arrhythmia (like ventricular arrhythmia), second or higher degree atrio-ventricular (AV) heart block. 7. An active infection that the investigator deems sufficient to exclude the patient from the study, including but not limited to urinary tract infections, respiratory tract infections, and diabetic foot infections with osteomyelitis osteomyelitis.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    3 sites. 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

  • 4. Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ

    COMPLETED

    Wroclaw, Poland, 53-114, Poland

  • Centralny Szpital Kliniczny Uniwersytetu Medycznego

    RECRUITING

    Lodz, Poland, 92-216, Poland

  • Centrum Onkologii im. prof. F. Łukaszczyka

    RECRUITING

    Bydgoszcz, Poland, 85-796, Poland

  • GAMMED Centrum Diagnostyczno-Lecznicze

    RECRUITING

    Warsaw, Poland, 02-351, Poland

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