Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Triple threat: new combo aims to tackle Hard-to-Treat prostate cancer

NCT ID NCT07226986

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 18, 2026 · Updated 5 times

Summary

This study tests a new drug, AMO959, combined with a targeted radiation therapy (Pluvicto) and a hormone therapy in men with a specific type of advanced prostate cancer (PSMA-positive mCRPC) that has stopped responding to prior hormone treatment. The trial has two phases: first to check safety and dosing, then to see if the combo can lower PSA levels. About 123 men will take part.

What this could mean

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

Active substance
AMO959 (a DNA damage repair blocker) combined with Pluvicto (a targeted radiation drug) and a hormone therapy (enzalutamide or abiraterone)
What this could lead to
If successful, this combination could offer a new treatment option for men with advanced prostate cancer that has stopped responding to hormone therapy.
What could go wrong
This is an early-phase trial (Phase 1/2) with only 123 participants, so safety and effectiveness are not yet proven. The combination may cause significant side effects or fail to improve outcomes.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 123 people

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

Started

Dec 2025

Expected to finish

Sep 2029

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.

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 of 0 to 2. * Participants must have histologically confirmed adenocarcinoma of the prostate. Participants with other histology (e.g. neuroendocrine, intraductal subtype) are not eligible. * Phase Ib: Prior exposure of up to 1 line of taxane-based chemotherapy is permissible. Phase II: Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting). * Participants must have PSMA-PET positive disease assessed by using a PSMA imaging agent that is approved as per protocol and are eligible as determined by the sponsor's central reading rules. * Castration level of testosterone (\< 50 ng/dL), and/or use of concomitant ADT * Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI), based on at least 1 of the following criteria: * Serum/plasma PSA progression is defined as 2 increases in PSA measured at least 1 week apart. The minimal start value is 2.0 ng/mL; 1.0 ng/mL is the minimal starting value if confirmed rise in PSA is the only indication of progression as per PCWG3 guidelines. * Soft-tissue progression defined PCWG3-modified RECIST v1.1 (Eisenhauer et al 2009, Scher et al 2016). * Progression of bone disease: 2 new lesions; only positivity on the bone scan defines metastatic disease to bone (PCWG3 criteria Scher et al 2016). Key Exclusion Criteria: * Concurrent local (radiation therapy to the prostate with curative intent or other prostate antineoplastic ablative procedures) or systemic (hormonal ablation, chemotherapy, immunotherapy, , RLTs) antineoplastic treatments, or within 28 days of enrollment (Phase Ib) or randomization (Phase II) * Prior treatment with any RLT or PSMA-targeted agents (approved or investigational) * Any other investigational agents within 28 days prior to first dose of any study treatment * Concurrent serious medical conditions that may interfere with study procedures or followup * Participants with a history of CNS metastases must have received therapy (surgery, whole brain radiation therapy, stereotactic radiosurgery) and be neurologically stable, asymptomatic, and not taking corticosteroids for the purpose of maintaining neurologic integrity. Other protocol-defined inclusion/exclusion criteria may apply.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Metastatic castration resistant prostate cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

PSMA-positive metastatic castration resistant prostate cancer (MCRPC) with prior exposure to one prior arpi who are candidates for taxane-based chemotherapy

How to take part

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

  1. The places running it

    22 sites in 7 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

  • Novartis Investigative Site

    RECRUITING

    Malvern, Victoria, 3144, Australia

  • Novartis Investigative Site

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Novartis Investigative Site

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Novartis Investigative Site

    RECRUITING

    Murdoch, Western Australia, 6150, Australia

  • Novartis Investigative Site

    RECRUITING

    Bordeaux, 33076, France

  • Novartis Investigative Site

    RECRUITING

    Clermont-Ferrand, 63011, France

  • Novartis Investigative Site

    RECRUITING

    Nantes, 44093, France

  • Novartis Investigative Site

    RECRUITING

    Villejuif, 94800, France

  • Novartis Investigative Site

    RECRUITING

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    RECRUITING

    Essen, 45147, Germany

  • Novartis Investigative Site

    RECRUITING

    München, 80377, Germany

  • Novartis Investigative Site

    RECRUITING

    Cona, FE, 44124, Italy

  • Novartis Investigative Site

    RECRUITING

    Milan, MI, 20133, Italy

  • Novartis Investigative Site

    RECRUITING

    Naples, 80131, Italy

  • Novartis Investigative Site

    RECRUITING

    Sapporo, Hokkaido, 0608648, Japan

  • Novartis Investigative Site

    RECRUITING

    Granada, Andalusia, 18014, Spain

  • Novartis Investigative Site

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28041, Spain

  • Rio Grande Urology

    RECRUITING

    El Paso, Texas, 79912, United States

  • Utah Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84107, United States

  • VA Greater LA Healthcare System

    RECRUITING

    Los Angeles, California, 90073, United States

More trials for these conditions

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