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New hope for prostate cancer: extended radioactive therapy shows promise

NCT ID NCT06531499

Disease control Sponsor: Novartis Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage trial is testing a radioactive drug called Lutetium-177 vipivotide tetraxetan in men with a specific type of advanced prostate cancer that has stopped responding to hormone therapy. The drug targets and delivers radiation directly to cancer cells. The study aims to see if giving up to 12 cycles of treatment is safe and how the radiation affects the body. About 106 men who have not had chemotherapy will participate.

What this could mean

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

Active substance
Lutetium-177 vipivotide tetraxetan (a radioactive drug that targets prostate cancer cells)
What this could lead to
If successful, this could lead to a longer treatment option for men with advanced prostate cancer who have not yet had chemotherapy, potentially controlling the disease for a longer period.
What could go wrong
This is an early Phase 1 trial with only 106 participants, so safety and effectiveness are not yet proven. The radioactive treatment may cause side effects like damage to healthy organs or bone marrow suppression.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 106 people

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

Started

Nov 2024

Expected to finish

Nov 2028

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 to 100 years

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.

Key Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Participants must be adults ≥ 18 years of age. * Participants must have an ECOG performance status ≤ 1. * Participants must have histological confirmation of adenocarcinoma of the prostate. * Participants must be PSMA-positive per 68Ga-PSMA PET/CT scans at baseline * Participants must have a castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L) either by pharmaceutical or surgical methods. * Participants must have progressed only once on prior second generation ARPIs * Documented progressive mCRPC * Participants must have ≥ 1 metastatic lesion by conventional imaging that is present on screening/baseline CT, MRI, or bone scan * Renal: eGFR ≥ 60 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. * Participants must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies except alopecia. Key exclusion Criteria: * Previous treatment with any of the following within 6 months of study enrollment: Strontium 89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation * Any previous radioligand therapy. * Prior treatment with cytotoxic chemotherapy for metastatic castration-resistant or metastatic hormone-sensitive prostate cancer (mHSPC) (e.g., taxanes, platinum, estramustine, vincristine, methotrexate, etc.), immunotherapy or biological therapy \[including monoclonal antibodies\]. \[Note: Taxane exposure (maximum 6 cycles) in the adjuvant or neoadjuvant setting is allowed if 12 months have elapsed since completion of this adjuvant or neoadjuvant therapy. Prior treatment with sipuleucel-T is allowed\]. * Concurrent therapies: cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitor, biological, or investigational therapy * History of myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature and/or clinically active significant cardiac disease * Concurrent serious acute or chronic nephropathy and/or moderate to severe renal impairment as determined by the principal investigator. * Diagnosed with other active malignancies that are expected to alter life expectancy or may interfere with disease assessment * Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 14 weeks after stopping study treatment. * Concurrent urinary outflow obstruction or unmanageable urinary incontinence * History of somatic or psychiatric disease/condition that may interfere with the aims and assessments of the study. Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma

As listed by the trial registrant

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

Metastatic castration resistant 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

    21 sites in 6 countries. 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

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Nebraska Cancer Specialists

    RECRUITING

    Omaha, Nebraska, 68130, United States

  • Novartis Investigative Site

    RECRUITING

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Novartis Investigative Site

    RECRUITING

    Wuppertal, North Rhine-Westphalia, 42283, Germany

  • Novartis Investigative Site

    RECRUITING

    Aachen, 52074, Germany

  • Novartis Investigative Site

    RECRUITING

    Berlin, 13353, Germany

  • Novartis Investigative Site

    RECRUITING

    Essen, 45147, Germany

  • Novartis Investigative Site

    RECRUITING

    München, 80377, Germany

  • Novartis Investigative Site

    RECRUITING

    Rostock, 18057, Germany

  • Novartis Investigative Site

    RECRUITING

    Nijmegen, Gelderland, 6500HB, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    RECRUITING

    Majadahonda, Madrid, 28222, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08041, Spain

  • Novartis Investigative Site

    RECRUITING

    Bellinzona, 6500, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Bern, 3010, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Birmingham, West Midlands, B15 2TH, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Glasgow, G12 0YN, United Kingdom

  • Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

  • University of California LA

    RECRUITING

    Los Angeles, California, 90095, United States

  • Wash U School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.