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New radioactive cocktail aims to shrink tough prostate tumors

NCT ID NCT06855277

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 7 times

Summary

This Phase 3 trial tests whether adding a radioactive drug called AAA817 to standard hormone therapy can slow cancer growth better than current treatments alone. About 940 men with PSMA-positive metastatic castration resistant prostate cancer will be randomly assigned to receive either AAA817 plus an ARPI (enzalutamide or abiraterone) or standard care. The study measures how long participants live without their cancer worsening and overall survival.

What this could mean

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

Active substance
AAA817 (a radioactive drug that targets prostate cancer cells) plus an androgen receptor pathway inhibitor (ARPI, a hormone-blocking drug)
What this could lead to
If successful, this combination could offer a new treatment option that delays cancer progression and extends survival for men with advanced prostate cancer that has stopped responding to hormone therapy.
What could go wrong
This is an early-stage Phase 3 trial, so results are not yet known. The radioactive treatment may cause side effects like bone marrow suppression or kidney damage, and not all participants may benefit.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 940 people

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

Started

Jul 2025

Expected to finish

Nov 2032

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 of 0 to 2. * Participants must have histological, and/or cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible. * Participants who have received taxane-based chemotherapy in mHSPC setting are eligible if they are deemed appropriate for chemotherapy, ARPI change or AAA617 as the next line of therapy in the opinion of the Investigator. Note: Participants who have received taxane-based chemotherapy for mCRPC are excluded. * Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting). * Participants must have PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol. * 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). * Participants with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer, as per local testing, may be enrolled if they had prior exposure to PARPi. Key Exclusion Criteria: * Previous anti-cancer treatment with any approved or investigational radiopharmaceuticals (for example, \[177Lu\]Lu-PSMA, \[177Lu\]-DOTA, or Radium- 223.) * Previous treatment with any external beam radiotherapy including hemi-body radiation within 6 weeks of randomization (within 2 weeks for radiotherapy of localized metastases). * Any prior PARP inhibitor or other systemic anticancer therapy administered for metastatic castration-resistant prostate cancer (mCRPC). Any other approved or investigational systemic therapy (including chemotherapy, immunotherapy, biologics, or monoclonal antibodies) is prohibited within 28 days or 5 half-lives (whichever is shorter) before randomization. Note: Prior ARPI administered in the mHSPC setting or earlier may continue until C1D1. 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

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

    95 sites in 11 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

  • Astera Cancer Center

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

  • Baptist Health South

    RECRUITING

    Miami, Florida, 33173, United States

  • Bassett Medical Center

    RECRUITING

    Cooperstown, New York, 13326, United States

  • Beth Israel Deaconess Med 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, 02215, United States

  • East Jefferson Hospital

    RECRUITING

    Metairie, Louisiana, 70006, United States

  • Florida Cancer Specialists

    RECRUITING

    Fort Myers, Florida, 33901, United States

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • MUSC Hollings Cancer Center

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10461, United States

  • Nebraska Cancer Specialists

    RECRUITING

    Omaha, Nebraska, 68154, United States

  • New Jersey Urology LLC

    RECRUITING

    Voorhees Township, New Jersey, 08043, United States

  • New Mexico Oncology Hematology

    RECRUITING

    Albuquerque, New Mexico, 87109, United States

  • Northwest Medical Specialties

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Novartis Investigative Site

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

  • Novartis Investigative Site

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Novartis Investigative Site

    RECRUITING

    Malvern, Victoria, 3144, Australia

  • Novartis Investigative Site

    RECRUITING

    Murdoch, Western Australia, 6150, Australia

  • Novartis Investigative Site

    RECRUITING

    Adelaide, 5000, 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

    Guangzhou, Guangdong, 510120, China

  • Novartis Investigative Site

    RECRUITING

    Guangzhou, Guangdong, 510632, 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

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    RECRUITING

    Hangzhou, Zhejiang, 310007, China

  • Novartis Investigative Site

    RECRUITING

    Hangzhou, Zhejiang, 310022, 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

    Shanghai, 200127, China

  • Novartis Investigative Site

    RECRUITING

    Tianjin, 300300, China

  • Novartis Investigative Site

    RECRUITING

    Tianjin, 300480, China

  • Novartis Investigative Site

    RECRUITING

    Hong Kong, 999077, Hong Kong

  • Novartis Investigative Site

    RECRUITING

    Gurgaon, Haryana, 122002, India

  • Novartis Investigative Site

    RECRUITING

    Bengaluru, Karnataka, 560066, India

  • Novartis Investigative Site

    RECRUITING

    Mumbai, Maharashtra, 400012, India

  • Novartis Investigative Site

    RECRUITING

    Nagoya, Aichi-ken, 4668560, Japan

  • Novartis Investigative Site

    RECRUITING

    Sapporo, Hokkaido, 0608648, Japan

  • Novartis Investigative Site

    RECRUITING

    Kobe, Hyōgo, 6500017, Japan

  • Novartis Investigative Site

    RECRUITING

    Kobe, Hyōgo, 6500047, Japan

  • Novartis Investigative Site

    RECRUITING

    Kamakura, Kanagawa, 2478533, Japan

  • Novartis Investigative Site

    RECRUITING

    Yokohama, Kanagawa, 2360004, Japan

  • Novartis Investigative Site

    RECRUITING

    Chuo Ku, Tokyo, 1040045, Japan

  • Novartis Investigative Site

    RECRUITING

    Chiba, 2608717, Japan

  • Novartis Investigative Site

    RECRUITING

    Fukuoka, 8110213, Japan

  • Novartis Investigative Site

    RECRUITING

    Fukuoka, 8120033, Japan

  • Novartis Investigative Site

    RECRUITING

    Fukuoka, 8128582, Japan

  • Novartis Investigative Site

    RECRUITING

    Fukushima, 9601295, Japan

  • Novartis Investigative Site

    RECRUITING

    Hiroshima, 7348551, Japan

  • Novartis Investigative Site

    RECRUITING

    Kyoto, 6068507, Japan

  • Novartis Investigative Site

    RECRUITING

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    RECRUITING

    Singapore, 168583, Singapore

  • Novartis Investigative Site

    RECRUITING

    Singapore, 169608, Singapore

  • Novartis Investigative Site

    RECRUITING

    Seoul, 01812, South Korea

  • 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, 06351, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    RECRUITING

    Kaohsiung City, 833, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Taoyuan, 33305, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    London, EC1A 7BE, United Kingdom

  • Rocky Mountain Cancer Centers

    RECRUITING

    Denver, Colorado, 80218, United States

  • Sansum Clinic

    RECRUITING

    Santa Barbara, California, 93105, United States

  • Stanford University Medical Center

    RECRUITING

    Palo Alto, California, 94304, United States

  • Swedish Medical Center

    RECRUITING

    Seattle, Washington, 98122-4379, United States

  • Tennessee Oncology PLLC

    RECRUITING

    Chattanooga, Tennessee, 37404, United States

  • Univ Of Iowa Hospitals And Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University Cancer and Blood Center LLC

    RECRUITING

    Athens, Georgia, 30607, United States

  • University of Illinois Cancer Center at Chicago

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Kansas Hospital

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Rochester Medical Ctr

    RECRUITING

    Rochester, New York, 14642, United States

  • Urology Austin

    RECRUITING

    Lakeway, Texas, 78738, United States

  • Urology Centers Of Alabama Pc

    RECRUITING

    Homewood, Alabama, 35209, United States

  • Urology Group - Solaris Network

    RECRUITING

    Cincinnati, Ohio, 45212, United States

  • Urology San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Wash U School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medicine NY-Presb

    RECRUITING

    New York, New York, 10021, United States

  • Woodlands Cancer Institute American Oncology Partners

    RECRUITING

    The Woodlands, Texas, 77384, United States

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