At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- 225Ac-PSMA-Trillium (BAY3563254) (drug)
- How long the study runs
- Study runs about 98 months (dates as stated)
- About the drug or intervention
- 225Ac-PSMA-Trillium (BAY3563254) — drug: Intravenous slow injection on Day 1 of a 6 week treatment cycle.
- Patient visit burden
- Not specified by the sponsor
In plain English
This is a first-in-human study testing a new radioactive drug called 225Ac-PSMA-Trillium (BAY 3563254) in men with advanced metastatic castration-resistant prostate cancer (mCRPC) that has spread and no longer responds to hormone treatment. The drug targets a protein called PSMA found on prostate cancer cells. The study is paid for (sponsored) by Bayer.
Who can take part
- Men with advanced prostate cancer that has spread and is not responding to hormone treatment (pathology must show adenocarcinoma, without small-cell or neuroendocrine features)
- Have already had at least one newer hormone drug, such as enzalutamide, apalutamide, darolutamide or abiraterone
- Have had surgery to remove the testicles (orchiectomy) or are on ongoing hormone-blocking treatment, with testosterone levels kept very low
- Have had taxane chemotherapy (between 1 and 2 courses), or were not able to have it or chose not to have it. Rules differ for each group of the study. Some groups must not have had taxanes since the cancer became resistant to hormones. One group (Group C) must have already had an approved Lu-PSMA radioactive treatment and must not have stopped it because of side effects
- Be well enough to look after themselves (performance status score of 0 or 1)
- Have healthy enough blood, liver and kidneys, shown by blood tests done within 30 days before starting the study. Blood transfusions or certain growth-factor injections are not allowed in the 21 days before screening for these tests
- Have at least one PSMA-positive cancer deposit (one that shows up clearly) on a special PSMA PET/CT scan done for this study, as judged by the study doctor
- Have prostate cancer that is getting worse, shown by at least one of the following: two rising PSA (prostate-specific antigen) blood tests at least a week apart; growth of tumours on scans; or at least 2 new bone lesions on a bone scan. The starting PSA level must be at least 2.0 ng/mL
Who may not be able to
- Have any cancer deposits that do NOT show up on the PSMA PET/CT scan and are above certain sizes (for example, lymph nodes 2.5 cm or larger, or solid organ tumours 1 cm or larger)
- Have had certain anti-cancer treatment (chemotherapy, newer hormone drugs, biological therapy, immunotherapy or experimental drugs) within 4 weeks of starting the study, unless at least 5 half-lives of the previous drug have passed. Hormone injections (LHRH or GnRH) are allowed
- Have had previous treatment with actinium-225 radioactive drugs
- For most groups: any previous radioactive drug treatment is not allowed, except radium-223 more than 3 months before starting. For Group C: radium-223 more than 3 months before is allowed, and Lu-PSMA more than 6 weeks before is required. People who stopped these drugs because they could not tolerate them are excluded
- Had radiotherapy or surgery aiming to cure the cancer finishing less than 6 weeks before starting the study. Palliative (symptom-relieving) radiotherapy may be allowed within 6 weeks under certain conditions
- Still have moderate or worse side effects (grade 2 or higher) from previous cancer treatment that have not settled. Long-lasting mild side effects may be allowed with agreement between the doctor and the study sponsor
What taking part involves
- • The study drug is 225Ac-PSMA-Trillium (BAY 3563254), a new radioactive medicine designed to attach to the PSMA protein on prostate cancer cells
- • The study has two parts: dose escalation (finding a safe dose) and dose expansion (testing the dose in different groups of patients)
Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 198
- Started
- 2024-03-07
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for advanced metastatic castration-resistant prostate cancer
- • Phase1 - 198 participants
- • Researchers are looking for a better way to treat participants who have metastatic castration-resistant prostate cancer (mCRPC)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with advanced metastatic castration-resistant prostate cancer
Where?
- • London - University College London Hospitals NHS Foundation Trust | University College Hospital - NIHR UCLH Clinical Research Facility
- • Sutton - The Royal Marsden NHS Foundation Trust | Sutton - Oak Foundation Drug Development Unit
- • Newcastle upon Tyne - The Newcastle upon Tyne Hospitals NHS Foundation Trust | Freeman Hospital - Cancer Trials Research Centre
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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 use in the second part of the study. For this, each participant will receive one of different increasing amounts of BAY3563254. They will take BAY3563254 as an injection into a vein. All participants in the second part of the study, called dose expansion, will receive the most appropriate dose of BAY3563254 that was identified from the first part of the study. Participants in this study will take the study treatment once every 6 or 8 weeks, which is known as a treatment cycle. Each participant will have up to 4 of these treatment cycles, if the participant benefits from the treatment. Each participant will be in the study for approximately 6 years, including a screening phase of up to 30 days, 6 months of treatment depending on the participant's benefit, and a follow up phase of 60 months after the end of treatment. In addition, substudies performed during both dose escalation and dose expansion parts of the study will evaluate: * the clearance of radioactivity from the body over time * the doses of radiation that are delivered to normal organs and tumors During the study, the doctors and their study team will: * take blood and urine samples * check vital signs such as blood pressure, heart rate, and body temperature * examine heart health using electrocardiogram (ECG) * take tumor samples if required * check if the participants' cancer has grown and/or spread using CT (computed tomography) or MRI (magnetic resonance imaging) and bone scan * check the tumor status using PET (positron emission tomography) * check the amount of radiation absorbed by tumors and normal organs using SPECT/CT (single-photon emission tomography and computed tomography scan) * ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study. The treatment period ends with a visit in 6-12 weeks after the last BAY3563254 dose. About 6-12 weeks after the last dose and every 6 weeks thereafter, the study doctors and their team will check the participants' health and any changes in their cancer. This active follow-up period ends after 18 months. The long-term follow-up period will start after the end of the active follow-up visit and will continue for up to 60 months after the the last BAY3563254 dose. Participants will be contacted, typically by phone call or clinic visit, approximately every 12 weeks after the end of active follow-up.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ at least 1 novel
- ✓ at least 1 but no m
- ✓ for participants in Dose Expansion Group C only
- ✓ an established Lu-PSMA therapy (i
What the study is looking for
- ✓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...
- ✓Prior orchiectomy and/or ongoing androgen deprivation therapy and a castrate level of serum testosterone (\<50 ng/dL...
- ✓Prior taxane treatment:
- ✓Dose Expansion Group A: Participants must have had prior treatment with at least 1 but no more than 2 taxane...
Who cannot take part
- ✗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.
- ✗d. Predominantly necrotic lesions with greater than 1 cm of enhancing tissue on contrast-enhanced computed...
- ✗Prior radiopharmaceutical treatment using actinium-225.
- ✗Other prior radiopharmaceutical treatments:
See the full criteria
Where Is This Study? (3 UK sites)
University College London Hospitals NHS Foundation Trust | University College Hospital - NIHR UCLH Clinical Research Facility
London W1T 7HA, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825The Royal Marsden NHS Foundation Trust | Sutton - Oak Foundation Drug Development Unit
Sutton SM2 5PT, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust | Freeman Hospital - Cancer Trials Research Centre
Newcastle upon Tyne NE7 7DN, United Kingdom
How to Get in Touch
Bayer Clinical Trials Contact
Sponsor contactCONTACT
