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First-in-human Study of 225Ac-PSMA-Trillium (BAY 3563254) in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)
NCT06217822 · View on ClinicalTrials.gov ↗
Study Summary
Researchers are looking for a better way to treat participants who have metastatic castration-resistant prostate cancer (mCRPC). mCRPC is a cancer of the prostate (male reproductive gland found below the bladder) that has spread to other parts of the body. This type of prostate cancer does not respond to hormone treatment used to lower the level of testosterone, a male sex hormone, to prevent cancer from growing. The study treatment 225Ac-PSMA-Trillium, also called BAY3563254, is under development to treat advanced metastatic castration-resistant prostate cancer. It works by binding to PSMA and giving off radiation that can damage cancer cells and stop them from growing. The main purpose of this first-in-human study is to learn: * How safe is BAY3563254 in participants. * What is the recommended dose of BAY3563254 that is safe and works well that will be further tested in Part 2 of the study. * How well does BAY3563254 work in participants. To answer this, the researchers will look at: * The number and severity of medical problems including serious medical problems that participants experience after taking BAY3563254 * The number of dose-limiting toxicities (DLT) at each dose level. A DLT is a medical problem caused by a drug that is too severe to continue the use of that specific dose. * The number of participants whose cancer completely disappears (complete response) or reduces by at least 30% (partial response) after taking the treatment (also known as objective response rate (ORR)) * The number of participants who have a decrease in the levels of PSA\* by at least 50% in their blood (also known as PSA50). PSA is a protein made by the prostate gland. High levels of PSA may indicate the presence of prostate cancer. * Participants' best response to treatment based on their PSA levels (also known as the best overall PSA response). The study will have two parts. The first part, called dose escalation, is done to find the most appropriate dose of BAY3563254 for
Conditions Studied
Interventions
- DRUG 225Ac-PSMA-Trillium (BAY3563254)
Study Locations (20)
Other
- Institut Jules Bordet / Nuclear Medicine — Anderlecht
- AZ Groeninge Campus Kennedylaan - Urology — Kortrijk
- UZ Leuven - Campus Gasthuisberg - Nuclear Medicine — Leuven
- Tampere University Hospital, Tampereen yliopistollinen sairaala (TAYS) - Syöpäkeskus — Tampere
- Turku University Hospital, Turun yliopistollinen sairaala (TYKS) — Turku
- Istituto Europeo di Oncologia s.r.l - Medicina Nucleare — Milan
Quebec
- Centre Hospitalier de l'Universite de Montreal (CHUM) — Montreal
- McGill University Health Centre (MUHC) - Research Institute (RI) - McConnell Centre for Innovative Medicine (CIM) — Montreal
- Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hopital Fleurimont — Sherbrooke
Ontario
- Juravinski Cancer Centre - Clinical Trials Department — Hamilton
- Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology — Toronto
Uusimaa
- HUS-Yhtymä, Helsingin yliopistollinen sairaala (HUS) - Syöpäkeskus — Helsinki
- Docrates Mehiläinen Syöpäsairaala — Helsinki
California
- City of Hope - Duarte Cancer Center — Duarte
Minnesota
- M Health Fairview Masonic Cancer Clinic - Clinics and Surgery Center — Minneapolis
Nebraska
- XCancer Omaha — Omaha
Texas
- The University of Texas MD Anderson Cancer Center - Texas Medical Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 2024-03-07 |
| Est. Completion | 2031-05-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06217822
The ClinicalTrials.gov registry entry for NCT06217822 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 198 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Advanced Metastatic Castration-resistant Prostate Cancer appearing as the primary indexed condition, and to 1 intervention — of which 225Ac-PSMA-Trillium (BAY3563254) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06217822 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, Quebec, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06217822 about?
NCT06217822 is a clinical study titled "First-in-human Study of 225Ac-PSMA-Trillium (BAY 3563254) in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)". Researchers are looking for a better way to treat participants who have metastatic castration-resistant prostate cancer (mCRPC). mCRPC is a cancer of the prostate (male reproductive gland found below the bladder) that has spread to other parts of the body. This type of prostate cancer does not resp...
What is the current status of trial NCT06217822?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 198 participants. The study started on 2024-03-07. Estimated completion is 2031-05-24.
What conditions does trial NCT06217822 study?
This clinical trial studies the following conditions: Advanced Metastatic Castration-resistant Prostate Cancer, Prostate Specific Membrane Antigen (PSMA) Expression. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06217822?
The interventions under investigation include: 225Ac-PSMA-Trillium (BAY3563254) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06217822?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06217822 being conducted?
This trial has 20 study locations across California, Minnesota, Nebraska, Texas, Alberta. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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