Early access
Sign in
Not yet taking people in GermanyPhase 2

Switching to BMS-986365 in Metastatic Prostate Cancer With Weak PSA Response

Tests BMS-986365 in men whose PSA fell too little on hormone treatment.

Key facts

Who runs it
UroTrials GmbH
Where
Duisburg, Düsseldorf, Essen, Frankfurt Am Main, Freiburg im Breisgau, Hamburg, Heidelberg, Herne, Jena, München, Nürnberg, Rostock, Tübingen, Ulm, and Wuppertal, GermanySee the 16 sites
Trial code
Registry title
Phase 2 trial of ARPI to AR-degrader (BMS-986365) switch for suboptimal PSA-response in mCSPC (eARly-SWITCH).
Status
Not yet recruiting
Phase
Phase 2
People taking part
42 people, planned
Started
25 May 2026
Expected to end
25 May 2029
Type of study
Interventional
Record updated
10 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. 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

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Participants with predominant neuroendocrine prostate cancer (>50 %)
  • Participant has impaired cardiac function or clinically significant cardiac disease
  • Participants with any liver metastasis
  • Participants with any brain metastasis
  • Patients with 7-months PSA response < 0.2 ng/ml

Where in Germany

  • Urologicum DuisburgDuisburg, GermanyNot yet recruiting
  • Universitätsklinikum DüsseldorfDüsseldorf, GermanyNot yet recruiting
  • Universitätsklinikum EssenEssen, GermanyNot yet recruiting
  • Universitaetsklinikum Frankfurt AöRFrankfurt Am Main, GermanyNot yet recruiting
  • Medical Center- University of FreiburgFreiburg im Breisgau, GermanyNot yet recruiting
  • Universitätsklinikum Hamburg-EppendorfHamburg, GermanyNot yet recruiting
  • National Center for Tumor Diseases (NCT) HeidelbergHeidelberg, GermanyNot yet recruiting
  • Marien Hospital Herne Universitatsklinikum Der Ruhr-Universitat BochumHerne, GermanyNot yet recruiting
  • Universitätsklinikum JenaJena, GermanyNot yet recruiting
  • Klinikum rechts der Isar der Technischen Universität MünchenMünchen, GermanyNot yet recruiting
  • LMU Ludwig-Maximilians-Universität MünchenMünchen, GermanyNot yet recruiting
  • Klinikum Nürnberg NordNürnberg, GermanyNot yet recruiting
  • Rostock University Medical CenterRostock, GermanyNot yet recruiting
  • Universitätsklinikum Tübingen, Klinik für UrologieTübingen, GermanyNot yet recruiting
  • Universitaetsklinikum Ulm AoRUlm, GermanyNot yet recruiting
  • Helios Universitätsklinikum WuppertalWuppertal, GermanyNot yet recruiting

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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).
Plain-language title
Switching to BMS-986365 in Metastatic Prostate Cancer With Weak PSA ResponseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
10 June 2026