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New PET tracer could spare prostate cancer patients from repeated biopsies

NCT ID NCT06474806

Diagnosis Sponsor: Curasight Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tests whether a radioactive tracer called 64Cu-DOTA-AE105 can accurately show the aggressiveness of prostate cancer on a PET scan. About 168 men with low- to intermediate-risk prostate cancer will receive the tracer and undergo imaging. The goal is to see if this scan can replace or reduce the need for repeated tissue biopsies during active surveillance.

What this could mean

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

Active substance
64Cu-DOTA-AE105 (a radioactive tracer injected into the vein for PET imaging)
What this could lead to
If successful, this imaging agent could help doctors determine prostate cancer aggressiveness without repeated biopsies, improving monitoring for low-risk patients.
What could go wrong
This is an early-phase trial with only 168 participants, so results may not apply to all patients. The imaging accuracy may not be high enough to replace biopsies yet.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 168 people

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

Started

Jun 2024

Expected to finish

Jan 2027

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: * Pathology-verified prostate adenocarcinoma * International Society of Urological Pathology (ISUP) grade 1 to 3 * Localised prostate cancer (N0 and M0 status) (only required for ISUP 3 patients) 1. Newly diagnosed patients: Staging must be performed within 6 months from enrolment into the trial. 2. Active surveillance: N0/M0 at the time of diagnosis and no clinical suspicion of prostate cancer outside the prostatic bed at the time of enrolment into the trial. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Prostate biopsy within 1 to 6 months (patients with a biopsy within the last month are excluded to avoid possible inflammation artefacts on the PET scan) 1. The biopsy can be part of the primary staging, a confirmatory biopsy, or serial biopsy as part of an AS. 2. At least 1 core must be MRI-guided. Exclusion Criteria: * Any prior treatment for prostate cancer (surgery, external beam radiation therapy, brachytherapy, hormone therapy, or chemotherapy) * Chronic prostatitis (any signs or symptoms of chronic bacterial prostatitis or chronic pelvic prostatitis and pain syndrome, or known diagnosis of asymptomatic inflammatory prostatitis) * Acute infections within the prostatic bed or lower urinary tract infections * Participants have inadequate bone marrow, kidney, liver, heart, or lung function:

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma

As listed by the trial registrant

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

Prostate cancer

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    9 sites in 3 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Aalborg University Hospital

    RECRUITING

    Aalborg, Denmark

  • Herlev & Gentofte Hospital

    RECRUITING

    Herlev, Copenhagen, Denmark

  • Klinikum rechts der Isar

    RECRUITING

    Munich, Germany

  • Martini-klinik am UKE

    RECRUITING

    Hamburg, Germany

  • Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, 41345, Sweden

  • Skåne University Hospital

    RECRUITING

    Skåne, 20502, Sweden

  • Universitätsklinikum, Düsseldorf

    RECRUITING

    Düsseldorf, Germany

  • Vejle Hospital

    RECRUITING

    Vejle, Denmark, 7100, Denmark

  • Zeisigwaldkliniken Bethanien Chemnitz

    RECRUITING

    Chemnitz, Germany

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