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New radioactive drug targets Hard-to-Treat prostate cancer

NCT ID NCT06217822

Disease control Sponsor: Bayer 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Updated 2 times

Summary

This early-stage study tests a new drug, 225Ac-PSMA-Trillium, in people with advanced prostate cancer that has spread and no longer responds to hormone therapy. The drug delivers radiation directly to cancer cells to damage them. The main goals are to check safety, find the best dose, and see if it shrinks tumors or lowers PSA levels. About 198 participants will receive up to 4 doses, given every 6 to 8 weeks.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 198 people

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

Started

Mar 2024

Expected to finish

May 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 years and older

Sex

Anyone

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: * mCRPC with pathological confirmation of adenocarcinoma without small-cell or neuroendocrine features. * Previous treatment with at least 1 novel androgen axis drug (NAAD) (e.g., enzalutamide, apalutamide, darolutamide and/or abiraterone). * Prior orchiectomy and/or ongoing androgen deprivation therapy and a castrate level of serum testosterone (\<50 ng/dL or \<1.7 nmol/L). * Prior taxane treatment: * Dose Escalation: Participants must either have had prior treatment with at least 1 but no more than 2 taxane regimens, or been deemed ineligible for or refused taxane therapy on consultation with their physician * Dose Expansion Group A: Participants must have had prior treatment with at least 1 but no more than 2 taxane regimens, in the castration-resistant setting * Dose Expansion Group B: Participants must not have received any taxane regimens since becoming castration-resistant * Dose Expansion Group C: Participants must either have had prior treatment with at least 1 but no more than 2 taxane regimens, or been deemed ineligible for or refused taxane therapy on consultation with their physician * Prior treatment with an established Lu-PSMA therapy (i.e., dose activity and cycles comparable to approved treatments) is required for participants in Dose Expansion Group C only. More specifically, to qualify for this expansion group, participants must not have discontinued 177Lu-PSMA treatment due to intolerance. * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. * Adequate bone marrow, hepatic, and renal function, as assessed by the following laboratory requirements within 30 days before start of study intervention, as indicated below. Note that blood transfusions (red blood cells or platelets) and administration of G-CSF or GM-CSF are prohibited within 21 days prior to screening for the below bone marrow-related parameters. * Hemoglobin ≥9.0 g/dL * Absolute neutrophil count (ANC) ≥1500/mm\^3 * Platelet count ≥100,000/mm\^3 * Total bilirubin ≤1.5 x the Upper limit of normal (ULN), or ≤3×ULN if the participant has a confirmed history of Gilbert's syndrome (note that participants with Gilbert's syndrome should be carefully evaluated for other liver-related disorders that may impact their suitability for this study). * Alanine transaminase (ALT) and Aspartate transaminase (AST) ˂2.5 x ULN (≤5 x ULN for participants with liver involvement) * Participants on a stable dose of anticoagulation therapy are allowed to participate if they have no sign of bleeding or clotting, and prothrombin time international normalized ratio (PT/INR) and activated partial thromboplastin time (aPTT) test results are acceptable at the Investigator's discretion * Estimated glomerular filtration rate (eGFR) \>60 mL/min/1.73 m\^2, according to the Modified Diet in Renal Disease (MDRD) abbreviated formula and serum creatinine ≤1.5 x ULN * Participants must have at least one PSMA-positive (prostate-specific membrane antigen) distant metastatic lesion on the screening PSMA PET/CT scan using the study-designated PSMA PET tracers, as determined by the site Investigator. For eligibility purposes, a PSMA-positive lesion must have activity greater than the liver by visual assessment of the screening PSMA PET/CT. A PSMA-positive metastatic lesion should not correspond to a normal tissue structure or benign lesion. * Documented progressive mCRPC per PCWG3, and a minimum starting PSA value of 2.0 ng/mL is mandatory. Progressive mCRPC is defined as meeting at least one of the following criteria: 1. PSA progression (defined as 2 consecutive increases over a previous reference value obtained at a minimum of 1-week 2. Radiological progression in soft-tissue lesions according to PCWG3 modification of RECIST v1.1 criteria 3. Progression of bone disease (defined as ≥ 2 new bone lesions according to PCWG3 bone scan criteria) Exclusion Criteria: * Participants who have any of the following tumor lesions which are PSMA negative AND meet the size criteria below are excluded as determined by the site Investigator. A PSMA-negative lesion for eligibility purposes must have activity equal to or less than the liver by visual assessment of the screening PSMA PET/CT scan using the study-designated PSMA PET/CT tracers. A PSMA-negative metastatic lesion should not correspond to a normal tissue structure or benign lesion. * a. Any single or multiple lymph node(s) ≥2.5 cm in the short axis. * b. Any solid organ metastasis (e.g., lung, liver, adrenal glands, etc.) that is ≥1 cm in the short axis. * c. Any bone metastasis with a soft tissue component ≥ 1 cm in short axis with the soft tissue component being PSMA-negative. PSMA-negative osseous metastases without a soft tissue component do not exclude a participant. * d. Predominantly necrotic lesions with greater than 1 cm of enhancing tissue on contrast-enhanced computed tomography / magnetic resonance imaging (CT/MRI). * Prior systemic anticancer therapy including chemotherapy, NAAD, biologic therapy, immunotherapy, or investigational therapies within 4 weeks of the start of study treatment, except luteinizing hormone-releasing hormone (LHRH) or gonadotropin-releasing hormone (GnRH). Start of study treatment is allowed in shorter timeframes if 5 half-lives of the prior drug(s) have elapsed. * Prior radiopharmaceutical treatment using actinium-225. Other prior radiopharmaceutical treatments: * Dose escalation and Dose expansion Groups A and B: Prior treatment with a radiopharmaceutical is prohibited, with the exception of prior treatment with radium-223 dichloride more than 3 months before the start of study intervention. Note: Participants who have discontinued radium-223 dichloride treatment due to intolerance are excluded from Groups A and B. * Dose expansion Group C: Prior treatment with a radiopharmaceutical is prohibited with the following exceptions: Prior treatment with radium-223 dichloride more than 3 months before the start of study intervention is permitted; and prior treatment with 177Lu-PSMA more than 6 weeks before the start of study intervention is required. Note: Participants who have discontinued 177Lu-PSMA or radium-223 dichloride treatment due to intolerance are excluded from Group C. * Prior definitive therapy (radiotherapy or surgery) completed less than 6 weeks before the start of study intervention. Note that palliative radiotherapy completed less than 6 weeks before the start of study intervention will be allowed if: (i) no more than 10% of the participants' bone marrow is irradiated, (ii) it does not encompass all potential target/measurable lesions for participants in dose expansion. * Toxic effects of Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade ≥2 from prior anticancer therapy not yet stabilized or where significant post-treatment toxicities have been observed. Chronic toxic effects of CTCAE Grade ≤2 from prior anticancer therapy where no further resolution is expected do not require exclusion with agreement between the Investigator and Sponsor (e.g., chemotherapy-induced neuropathy, fatigue, alopecia, anorexia, etc.).

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma

As listed by the trial registrant

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

Advanced metastatic castration-resistant prostate cancer Prostate specific membrane antigen (PSMA) expression

How to take part

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

  1. The places running it

    32 sites in 10 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

  • AZ Groeninge Campus Kennedylaan - Urology

    RECRUITING

    Kortrijk, West Flanders, 8500, Belgium

  • Akademiska sjukhuset i Uppsala - Fas 1-enheten

    SUSPENDED

    Uppsala, Uppsala County, 751 85, Sweden

  • BC Cancer | Vancouver

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Centre Hospitalier de l'Universite de Montreal (CHUM) | Oncology

    RECRUITING

    Montreal, Quebec, H2X 0C1, Canada

  • Centre hospitalier universitaire de Sherbrooke (CHUS) | Oncology

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • City of Hope - Duarte Cancer Center

    NOT_YET_RECRUITING

    Duarte, California, 91010, United States

  • Cross Cancer Institute | Clinical Trials Unit

    WITHDRAWN

    Edmonton, Alberta, T6G 1Z2, Canada

  • Docrates Mehiläinen Syöpäsairaala

    RECRUITING

    Helsinki, Uusimaa, 00180, Finland

  • Erasmus Medisch Centrum

    WITHDRAWN

    Rotterdam, South Holland, 3015 CE, Netherlands

  • HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Syöpäkeskus

    RECRUITING

    Helsinki, Uusimaa, 00029, Finland

  • IRCCS Istituto Nazionale Tumori Fondazione Pascale - S. C. Medicina Nucleare e Terapia Metabolica

    NOT_YET_RECRUITING

    Naples, 80131, Italy

  • Institut Jules Bordet / Nuclear Medicine

    RECRUITING

    Anderlecht, Brussels Capital, 1070, Belgium

  • Istituto Europeo di Oncologia s.r.l - Medicina Nucleare

    RECRUITING

    Milan, 20141, Italy

  • Juravinski Cancer Centre | Clinical Trials

    RECRUITING

    Hamilton, Ontario, L8V 5C2, Canada

  • Kantonsspital Baden

    WITHDRAWN

    Baden, Canton of Aargau, 5404, Switzerland

  • Karolinska Universitetssjukhuset - Solna - Fas I-enheten Solna CKC

    RECRUITING

    Stockholm, Stockholm County, 171 76, Sweden

  • Kuopio University Hospital, Kuopion yliopistollinen sairaala (KYS) - Syövänhoitokeskus

    RECRUITING

    Kuopio, Northern Savonia, 70210, Finland

  • M Health Fairview Masonic Cancer Clinic - Clinics and Surgery Center

    NOT_YET_RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • Research Institute of the McGill University Health Centre | McConnell Centre for Innovative Medicine

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Sahlgrenska Universitetssjukhuset - Sahlgrenska Sjukhuset - Klinisk prövningsenhet Fas I/FIH

    RECRUITING

    Gothenburg, Västra Götaland County, 413 46, Sweden

  • Skånes Universitetssjukhus - Lund - Onkologens kliniska forskningsenhet

    RECRUITING

    Lund, Skåne County, 221 85, Sweden

  • Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS) - Syöpäkeskus

    SUSPENDED

    Tampere, Pirkanmaa, 33520, Finland

  • The Cancer Institute Hospital of JFCR

    NOT_YET_RECRUITING

    Koto-ku, Tokyo, 135-8550, Japan

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust | Freeman Hospital - Cancer Trials Research Centre

    NOT_YET_RECRUITING

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

  • The Royal Marsden NHS Foundation Trust | Sutton - Oak Foundation Drug Development Unit

    RECRUITING

    Sutton, Surrey, SM2 5PT, United Kingdom

  • The University of Texas MD Anderson Cancer Center - Texas Medical Center

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Turku University Hospital, Turun yliopistollinen sairaala (TYKS) - Syöpäkeskus

    RECRUITING

    Turku, Southwest Finland, 20540, Finland

  • UZ Leuven - Campus Gasthuisberg - Nuclear Medicine

    NOT_YET_RECRUITING

    Leuven, Flemish Brabant, 3000, Belgium

  • Universitair Medisch Centrum Groningen (UMCG) - UMC Groningen Comprehensive Cancer Center

    RECRUITING

    Groningen, 9713 GZ, Netherlands

  • University College London Hospitals NHS Foundation Trust | University College Hospital - NIHR UCLH Clinical Research Facility

    RECRUITING

    London, Greater London, W1T 7HA, United Kingdom

  • UniversitätsSpital Zürich (USZ) - Klinik für Medizinische Onkologie und Hämatologie

    RECRUITING

    Zurich, 8091, Switzerland

  • Universitätsspital Basel

    NOT_YET_RECRUITING

    Basel, Canton of Basel-City, 4056, Switzerland

  • XCancer Omaha

    NOT_YET_RECRUITING

    Omaha, Nebraska, 68130, United States

  • Yokohama City University Hospital

    NOT_YET_RECRUITING

    Yokohama, Kanagawa, 236-0004, Japan

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