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New radioactive therapy targets Hard-to-Treat prostate cancer

NCT ID NCT07441837

Disease control Sponsor: Ankara University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tests a radioactive drug called terbium-161 PSMA in 60 men with metastatic prostate cancer that has worsened after standard treatments. The drug is designed to seek out and destroy cancer cells. Participants will receive three cycles of the drug, and researchers will monitor tumor response, side effects, and quality of life.

What this could mean

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

Active substance
Terbium-161 PSMA I&T (a radioactive drug that targets prostate cancer cells)
What this could lead to
If successful, this could provide a new treatment option for men with advanced prostate cancer that has stopped responding to other therapies.
What could go wrong
This is a small, early-phase trial with only 60 participants. The drug may not shrink tumors or improve survival, and it can cause side effects like bone marrow suppression or organ 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

Phase 2

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

Participants

About 60 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Sep 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: * Men aged 18 years or older with mCRPC (histologically or cytologically confirmed adenocarcinoma of the prostate) * Progressive disease as defined by the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) under previous treatment with taxane chemotherapy (unless medically unsuitable) and at least one second-generation androgen receptor pathway inhibitor (ARPI) * Adequate bone marrow, hepatic, and renal function * Eastern Cooperative Oncology Group performance status of 0-2; * A life expectancy of at least 6 months. * On Ga-68 PSMA PET/CT, a maximum standardised uptake value (SUVmax) of at least 20 in at least one metastasis and SUVmax of at least 10 in measurable soft tissue metastases. * Patient has provided written informed consent * PSA progression: minimum of 2 rising PSA values from baseline measurement with interval of ≥1 wk between each measurement * Soft-tissue progression: per RECIST 1.1 * Bone progression: ≥2 new lesions on bone scan * At least 3 wk interval since completion of surgery or radiotherapy before registration Exclusion Criteria: * Patients with discordant metastases defined as positive on 2-\[¹⁸F\]fluoro-2-deoxy-D-glucose (FDG) PET-CT with minimal uptake on Ga-68-PSMA PET-CT * Previous treatment with another radioisotope * Other malignancies within the previous 2 years before registration other than basal cell or squamous cell carcinomas of skin or other cancers that are unlikely to recur within 24 months * Concurrent illnesses that could jeopardise the ability of the patient to undergo the trial procedures. * Patient has symptomatic brain metastases or leptomeningeal metastases * Patient has symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable for \>4 wk

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma 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

    4 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

  • Anadolu Sağlık Merkezi

    Istanbul, Turkey (Türkiye)

  • Ankara University Medical School Dept of Nuclear Medicine

    Ankara, 06590, Turkey (Türkiye)

  • Bilkent City Hospital

    Ankara, Turkey (Türkiye)

  • Memorial Sisli Hospital

    Istanbul, Turkey (Türkiye)

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