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New scan could spot prostate cancer spread better than current test

NCT ID NCT07635524

Diagnosis Sponsor: Hoag Memorial Hospital Presbyterian 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether a new radioactive imaging agent, 61Cu-NU101, can detect prostate cancer spread as well as or better than the current standard, Pylarify. 34 men with confirmed prostate cancer and visible disease on a prior Pylarify scan will receive one dose of 61Cu-NU101 followed by PET/CT imaging. The study compares the two scans to see if the new agent finds more or different cancer spots.

What this could mean

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

Active substance
61Cu-NU101 (a radioactive imaging agent)
What this could lead to
If successful, this could provide a new, equally effective or better imaging option for detecting prostate cancer spread.
What could go wrong
This is a small, early-phase study (34 people) comparing two scans, not a treatment. It may not show a meaningful improvement over the current standard.

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 34 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: 1. Biopsy proven prostate adenocarcinoma 2. Age ≥ 18 years 3. ECOG 0 or 2 4 .Oligometastatic disease (1-5 radiotracer avid disease sites) on 18F- piflufolastat PET/CT within 30 days of trial recruitment Exclusion Criteria: 1. Known allergy/hypersensitivity to PSMA-targeted imaging agents 2. Other active malignancy, other than the known prostate cancer

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Conditions

The condition(s) this trial relates to.

neoplasm Neoplasm Metastasis prostate adenocarcinoma prostate cancer

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 places running it

    2 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

  • Hoag Family Cancer Institute

    Newport Beach, California, 92663, United States

  • Washington Univeristy School of Medicine

    St Louis, Missouri, 63110, United States

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