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New hope for Tough-to-Treat prostate cancer: experimental drug AAA817 faces off against standard care

NCT ID NCT06780670

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests an experimental drug called AAA817 in adults with a specific type of advanced prostate cancer (PSMA-positive) that has worsened after prior treatments, including a targeted therapy. About 443 participants will be randomly assigned to receive either AAA817 or the doctor's choice of standard care. The goal is to see if AAA817 can slow cancer growth, improve survival, and have manageable 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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 443 people

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

Started

Feb 2025

Expected to finish

Jul 2033

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.

Inclusion Criteria: ∙ * adults ≥ 18 years of age. * ECOG performance status of 0 to 2. * histopathological and/or cytological confirmation of adenocarcinoma of the prostate. * PSMA-positive disease as assessed by PSMA PET/CT scan using an approved PSMA imaging agent as protocol instructed, * castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L). * Prior treatments with an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy, and progressed on or after \[177Lu\]Lu-PSMA targeted therapy. * ≥ 1 metastatic lesion that is present on screening/baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to randomization * eGFR as requested by the sponsor Exclusion Criteria: * Any investigational agents within 28 days prior to the day of randomization. * Any 225Ac-based investigational compound used prior to the day of randomization. * Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity. * Concurrent acute kidney injury (renal failure developed between 48 hours to 7 days) or chronic kidney disease (at least 3 months of ongoing renal injury) * Baseline xerostomia ≥ Grade 2 by CTCAE v.5 * History of uncontrolled hypertension, 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 * History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, non-invasive malignant colon polyps that have been removed). Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

castration-resistant 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

    81 sites in 12 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

  • AdventHealth

    RECRUITING

    Orlando, Florida, 32804, United States

  • Associated Med Professionals of NY

    RECRUITING

    Syracuse, New York, 13210, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Carolina Urologic Research Center

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Central Ohio Urology Group

    RECRUITING

    Gahanna, Ohio, 43230, United States

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • East Jefferson Hospital

    RECRUITING

    Metairie, Louisiana, 70006, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Fred Hutchinson Cancer Research Center

    RECRUITING

    Seattle, Washington, 98109-1024, United States

  • Hartford Hospital

    RECRUITING

    Hartford, Connecticut, 06102, United States

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Medical College Of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • Nebraska Cancer Specialists

    RECRUITING

    Omaha, Nebraska, 68154, United States

  • New Jersey Urology LLC

    RECRUITING

    Voorhees Township, New Jersey, 08043, United States

  • Novartis Investigative Site

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

  • Novartis Investigative Site

    RECRUITING

    Herston, Queensland, 4029, Australia

  • Novartis Investigative Site

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Novartis Investigative Site

    RECRUITING

    São Paulo, São Paulo, 01308-050, Brazil

  • Novartis Investigative Site

    RECRUITING

    São Paulo, São Paulo, 05652-000, Brazil

  • Novartis Investigative Site

    RECRUITING

    Fuzhou, Fujian, 350025, China

  • Novartis Investigative Site

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Novartis Investigative Site

    RECRUITING

    Wuhan, Hubei, 430030, China

  • Novartis Investigative Site

    RECRUITING

    Nanjing, Jiangsu, 210006, China

  • Novartis Investigative Site

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Novartis Investigative Site

    RECRUITING

    Shenyang, Liaoning, 110011, China

  • Novartis Investigative Site

    RECRUITING

    Xian, Shanxi, 710032, China

  • Novartis Investigative Site

    RECRUITING

    Xian, Shanxi, 710061, China

  • Novartis Investigative Site

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100034, China

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100036, China

  • Novartis Investigative Site

    RECRUITING

    Guangzhou, 510060, China

  • Novartis Investigative Site

    RECRUITING

    Shanghai, 200025, China

  • Novartis Investigative Site

    RECRUITING

    Shanghai, 200032, China

  • Novartis Investigative Site

    RECRUITING

    Tianjin, 300300, China

  • Novartis Investigative Site

    RECRUITING

    Hong Kong, 999077, Hong Kong

  • Novartis Investigative Site

    RECRUITING

    Beersheba, 8457108, Israel

  • Novartis Investigative Site

    RECRUITING

    Haifa, 3109601, Israel

  • Novartis Investigative Site

    RECRUITING

    Jerusalem, 9112001, Israel

  • Novartis Investigative Site

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Novartis Investigative Site

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • Novartis Investigative Site

    RECRUITING

    Sapporo, Hokkaido, 060-8648, Japan

  • Novartis Investigative Site

    RECRUITING

    Kobe, Hyōgo, 6500047, Japan

  • Novartis Investigative Site

    RECRUITING

    Yokohama, Kanagawa, 236-0004, Japan

  • Novartis Investigative Site

    RECRUITING

    Chiba, 260-8717, Japan

  • Novartis Investigative Site

    RECRUITING

    Fukuoka, 811-0213, Japan

  • Novartis Investigative Site

    RECRUITING

    Fukuoka, 812-0033, Japan

  • Novartis Investigative Site

    RECRUITING

    Fukuoka, 8128582, Japan

  • Novartis Investigative Site

    RECRUITING

    Fukushima, 9601295, Japan

  • Novartis Investigative Site

    RECRUITING

    Ishikawa, 9208641, Japan

  • Novartis Investigative Site

    RECRUITING

    Kyoto, 6068507, Japan

  • Novartis Investigative Site

    RECRUITING

    Petaling Jaya, Selangor, 46050, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Petaling Jaya, Selangor, 46150, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Singapore, 119228, Singapore

  • Novartis Investigative Site

    RECRUITING

    Singapore, 168583, Singapore

  • Novartis Investigative Site

    RECRUITING

    Singapore, 258499, Singapore

  • Novartis Investigative Site

    RECRUITING

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 05505, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    RECRUITING

    Basel, 4031, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Bellinzona, 6500, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Bern, 3010, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Taipei, 103616, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Taipei, 11217, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Taoyuan, 33305, Taiwan

  • Saint Johns Cancer Institute

    RECRUITING

    Santa Monica, California, 90404, United States

  • Sansum Clinic

    RECRUITING

    Santa Barbara, California, 93105, United States

  • Stanford University Medical Center

    RECRUITING

    Palo Alto, California, 94304, United States

  • Texas Oncology

    RECRUITING

    Dallas, Texas, 75251, United States

  • University Cancer and Blood Center LLC

    RECRUITING

    Athens, Georgia, 30607, United States

  • University of Kansas Hospital

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Urology San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Utah Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84107, United States

  • VA Greater LA Healthcare System

    RECRUITING

    Los Angeles, California, 90073, United States

  • VA Palo Alto Health Care System

    RECRUITING

    Palo Alto, California, 94304-1207, United States

  • WA Uni School Of Med

    RECRUITING

    St Louis, Missouri, 63110, United States

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