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Phase 2 trial of ARPI to AR-degrader (BMS-986365) switch for suboptimal PSA-response in mCSPC (eARly-SWITCH).
EU CTIS ID: 2025-523672-23-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Participants with predominant neuroendocrine prostate cancer (>50 %)
- Participants with any liver metastasis
- Participant has impaired cardiac function or clinically significant cardiac disease
- Participants with any brain metastasis
- Patients with 7-months PSA response < 0.2 ng/ml
See the full eligibility criteria
- 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
- Participants with predominant neuroendocrine prostate cancer (>50 %)
- Participants with any liver metastasis
- Participant has impaired cardiac function or clinically significant cardiac disease
- Participants with any brain metastasis
- Patients with 7-months PSA response < 0.2 ng/ml
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.