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Prostate cancer drug safety tracked for years in 700 patients

NCT ID NCT05803941

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study follows 700 adults with prostate cancer who have already received at least one dose of lutetium-177 PSMA-617 in earlier Novartis trials. Researchers will monitor long-term side effects such as dry mouth, eye dryness, bone marrow problems, kidney damage, and new cancers. The goal is to better understand the drug's safety over time.

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 PSMA-617 (a radioactive drug that targets prostate cancer cells)
What this could lead to
If successful, this study will confirm the long-term safety profile of this treatment, helping doctors manage risks like dry mouth, bone marrow suppression, and kidney damage.
What could go wrong
This is an observational follow-up study, not a test of new effectiveness. It only includes people who already tolerated the drug, so results may not apply to all patients. Rare or very late side effects may still be missed.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 700 people

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

Started

Aug 2023

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: * Signed informed consent must be obtained prior to participation in the study * Must have received at least one dose of AAA617 within an interventional, Phase I-IV Novartis sponsored clinical trial in prostate cancer and have fulfilled the trial's requirements that allows them to participate in this study. Exclusion Criteria: \- Inability to complete the needed investigational examinations due to any reason.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

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

    54 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

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Corewell Health William Beaum Hosp

    RECRUITING

    Royal Oak, Michigan, 48073-6769, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Hartford Hospital

    RECRUITING

    Hartford, Connecticut, 06102, United States

  • Mayo Clinic Arizona

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • Nebraska Cancer Specialists

    RECRUITING

    Omaha, Nebraska, 68154, United States

  • Novartis Investigative Site

    RECRUITING

    Linz, 4020, Austria

  • Novartis Investigative Site

    RECRUITING

    Vienna, 1090, Austria

  • Novartis Investigative Site

    RECRUITING

    Ghent, 9000, Belgium

  • Novartis Investigative Site

    RECRUITING

    Montreal, Quebec, H2X 1R9, Canada

  • Novartis Investigative Site

    RECRUITING

    Olomouc, 779 00, Czechia

  • Novartis Investigative Site

    RECRUITING

    Prague, 150 06, Czechia

  • Novartis Investigative Site

    RECRUITING

    Lyon, 69373, France

  • 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

    Maastricht, Limburg, 6229 HX, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Delft, South Holland, 2625 AD, Netherlands

  • Novartis Investigative Site

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    RECRUITING

    Sabadell, Barcelona, 08208, Spain

  • Novartis Investigative Site

    RECRUITING

    Majadahonda, Madrid, 28222, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28034, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28040, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28041, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28046, Spain

  • Novartis Investigative Site

    RECRUITING

    Valencia, 46026, Spain

  • Novartis Investigative Site

    RECRUITING

    Gothenburg, 413 45, Sweden

  • Novartis Investigative Site

    RECRUITING

    Stockholm, 17176, Sweden

  • Novartis Investigative Site

    RECRUITING

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Barnet, EN5 3DJ, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Glasgow, G12 0YN, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Middlesbrough, TS4 3BW, United Kingdom

  • Ochsner Clinic Foundation

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Onco Hemato Asso of SW Virginia

    RECRUITING

    Roanoke, Virginia, 24014, United States

  • Parkview Research Center

    RECRUITING

    Fort Wayne, Indiana, 46845, United States

  • Providence Saint Johns Health Ctr

    RECRUITING

    Santa Monica, California, 90404, United States

  • St. Joseph Hospital

    RECRUITING

    Orange, California, 92686, United States

  • Tulane Cancer Center

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • UT Health Science Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Univ of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Univ of Texas Southwest Med Center

    RECRUITING

    Dallas, Texas, 75390-9034, United States

  • University Cancer and Blood Center LLC

    RECRUITING

    Athens, Georgia, 30607, United States

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Mississippi Med Ctr

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • Urology Cancer Center PC

    RECRUITING

    Omaha, Nebraska, 68130, United States

  • VA Medical Center

    RECRUITING

    Washington D.C., District of Columbia, 20422, United States

  • Wash U School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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