2025-523672-23-00Not yet recruitingPhase 2
Phase 2 trial of ARPI to AR-degrader (BMS-986365) switch for suboptimal PSA-response in mCSPC (eARly-SWITCH).
A phase 2 trial of BMS-986365 in mCSPC patients with suboptimal PSA-response after 7 months of Androgen Deprivation Therapy (ADT) plus Androgen Receptor Pathway Inhibition (ARPI).
Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 Jun 2026
Brief summary (registry, in English)
Primary objective of this phase II trial is to explore the efficacy of an ARPI to BMS-986365 switch in participants with suboptimal 7-months (±4 weeks) PSA response despite combined ADT + ARPI-treatment for mCSPC with PSA response-rate as primary endpoint.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 16 Mar 2026
- Start date
- 25 May 2026
- Lead sponsor
- UroTrials GmbH
- Diseases
- Prostate cancer
- EU CT number
- 2025-523672-23-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 42
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has spread and still responds to hormone treatment. Their PSA is still detectable after about 7 months of hormone treatment plus an ARPI drug.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Documented metastatic castration-sensitive prostate cancer. Symptoms from the cancer are allowed if pain score and pain medication have been stable for at least 4 weeks. ECOG performance status 0 or 1.
- Earlier treatment
- Ongoing ADT plus one ARPI: abiraterone (with prednisone or prednisolone), apalutamide, darolutamide (with or without docetaxel) or enzalutamide. At least 4 months of ARPI treatment before registration.
- Biomarker or test result
- PSA of 0.2 ng/ml or higher, 7 months (± 4 weeks) after anti-hormonal treatment started.
Main reasons for not taking part
- Mostly neuroendocrine prostate cancer (more than 50 %)
- Any liver metastasis
- Any brain metastasis
- Impaired heart function or significant heart disease
- PSA below 0.2 ng/ml at 7 months
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participants with predominant neuroendocrine prostate cancer (>50 %)
- Participant has impaired cardiac function or clinically significant cardiac disease
Other
- Participants with any liver metastasis
- Participants with any brain metastasis
- Patients with 7-months PSA response < 0.2 ng/ml
Who the study is looking for
- Adult males of at least 18 years with signed written consent
- Participants with documented metastatic castration sensitive prostate cancer
- Detectable PSA (PSA ≥0.2 ng/ml) 7 months (± 4 weeks) after start ofanti-hormonal treatment initiation (ADT and/or ARPI, whatever was applied first)
- Ongoing treatment with ADT and one of the following ARPIs: Abiraterone (plus Prednisone/Prednisolone), Apalutamide, Darolutamide (± Docetaxel), Enzalutamide
- Minimum prior ARPI treatment duration of 4 months until registration
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Asymptomatic or symptomatic from metastatic prostate cancer based on BPI-SF score but must be stable with regard to BPI-SF score and pain medication, the later for at least 4 weeks prior to registration
- Adequate blood count, liver and renal function
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Urologicum Duisburg | Duisburg | Germany | Not yet recruiting |
| Universitätsklinikum Düsseldorf | Düsseldorf | Germany | Not yet recruiting |
| Universitätsklinikum Essen | Essen | Germany | Not yet recruiting |
| Universitaetsklinikum Frankfurt AöR | Frankfurt Am Main | Germany | Not yet recruiting |
| Medical Center- University of Freiburg | Freiburg im Breisgau | Germany | Not yet recruiting |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | Germany | Not yet recruiting |
| National Center for Tumor Diseases (NCT) Heidelberg | Heidelberg | Germany | Not yet recruiting |
| Marien Hospital Herne Universitatsklinikum Der Ruhr-Universitat Bochum | Herne | Germany | Not yet recruiting |
| Universitätsklinikum Jena | Jena | Germany | Not yet recruiting |
| LMU Ludwig-Maximilians-Universität München | München | Germany | Not yet recruiting |
| Klinikum rechts der Isar der Technischen Universität München | München | Germany | Not yet recruiting |
| Klinikum Nürnberg Nord | Nürnberg | Germany | Not yet recruiting |
| Rostock University Medical Center | Rostock | Germany | Not yet recruiting |
| Universitätsklinikum Tübingen, Klinik für Urologie | Tübingen | Germany | Not yet recruiting |
| Universitaetsklinikum Ulm AoR | Ulm | Germany | Not yet recruiting |
| Helios Universitätsklinikum Wuppertal | Wuppertal | Germany | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.