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New hope for tough prostate cancer: drug combo trial launches

NCT ID NCT07047118

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 18, 2026 · Updated 8 times

Summary

This Phase II trial tests a new drug, JSB462 (luxdegalutamide), combined with a radioactive therapy (Pluvicto) in 138 men with PSMA-positive metastatic castration-resistant prostate cancer that has progressed after prior treatments. The study aims to see if the combination works better than Pluvicto alone and to find the best dose for future studies.

What this could mean

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

Active substance
JSB462 (luxdegalutamide) and lutetium (177Lu) vipivotide tetraxetan (Pluvicto)
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 standard therapies.
What could go wrong
This is a Phase II trial with only 138 participants, so results are preliminary. The combination may not improve outcomes over Pluvicto alone and could cause additional side effects.

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

138 people

The number who actually took part.

Started

Jul 2025

Expected to finish

May 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 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: * Adult male participants with histologically and/or cytologically confirmed adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible. * An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade ≤2. * At least 1 bone or visceral metastatic lesion present on baseline CT, MRI, or bone scan imaging obtained ≤28 days prior to initiation of study treatment. * Participants must be \[68Ga\]Ga-PSMA-11 PET/CT scan positive and eligible as determined by the sponsor's central reader. * Participant must have prior exposure to at least one second generation ARPI in the metastatic/advanced setting. * Previous treatment with a maximum of 2 taxane regimens is allowed. * Participants eligible for PARPi and/or immune checkpoint inhibitor (per local testing and according to investigator's judgement) are eligible to participate if they have previous exposure to this(these) therapy(ies). Key Exclusion Criteria: * Prior treatment with any RLT (approved or investigational) is not allowed * Prior treatment with a protein degrader compound that targets AR is not allowed 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 prostate cancer Prostatic Neoplasms, Castration-Resistant

As listed by the trial registrant

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

Prostatic cancer, castration-resistant

Contacts and locations

Locations

  • City of Hope National Medical

    Duarte, California, 91010, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • NYU Laura and Isaac Perlmutter Cancer Center

    New York, New York, 10016, United States

  • Novartis Investigative Site

    Darlinghurst, New South Wales, 2010, Australia

  • Novartis Investigative Site

    Adelaide, South Australia, 5000, Australia

  • Novartis Investigative Site

    Melbourne, Victoria, 3004, Australia

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020, Austria

  • Novartis Investigative Site

    Linz, 4020, Austria

  • Novartis Investigative Site

    Vienna, 1090, Austria

  • Novartis Investigative Site

    Burnaby, British Columbia, V5G 4P3, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H3T 1E2, Canada

  • Novartis Investigative Site

    Beijing, 100034, China

  • Novartis Investigative Site

    Beijing, 100036, China

  • Novartis Investigative Site

    Prague, 150 06, Czechia

  • Novartis Investigative Site

    Brest, 29200, France

  • Novartis Investigative Site

    Marseille, 13273, France

  • Novartis Investigative Site

    Tours, 37044, France

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Rostock, 18057, Germany

  • Novartis Investigative Site

    Afula, 1834111, Israel

  • Novartis Investigative Site

    Beersheba, 8457108, Israel

  • Novartis Investigative Site

    Haifa, 3109601, Israel

  • Novartis Investigative Site

    Jerusalem, 9103102, Israel

  • Novartis Investigative Site

    Petah Tikva, 4941492, Israel

  • Novartis Investigative Site

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    Genova, GE, 16132, Italy

  • Novartis Investigative Site

    Roma, RM, 00128, Italy

  • Novartis Investigative Site

    Nijmegen, Gerlderland, 6532 SZ, Netherlands

  • Novartis Investigative Site

    Hoofddorp, 2134 TM, Netherlands

  • Novartis Investigative Site

    Singapore, 168583, Singapore

  • Novartis Investigative Site

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    Seoul, 05505, South Korea

  • Novartis Investigative Site

    Granada, Andalusia, 18014, Spain

  • Novartis Investigative Site

    El Palmar, Murcia, 30120, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Seville, 41013, Spain

  • Novartis Investigative Site

    Taipei, 103616, Taiwan

  • Providence Saint Johns Health Ctr

    Santa Monica, California, 90404, United States

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218, United States

  • Univ of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232, United States

  • Urology San Antonio

    San Antonio, Texas, 78229, United States

  • XCancer Omaha LLC

    Omaha, Nebraska, 68130, United States

  • Yale University School Of Medicine

    New Haven, Connecticut, 06520, United States

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