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Study of Apalutamide with Carotuximab for Metastatic, Castration-Resistant Prostate Cancer

This study is for men with prostate cancer that has spread (metastatic) and is no longer responding to hormone therapy (castration-resistant). You must have already received certain hormone therapies (ARSI, or androgen receptor signaling inhibitor) like abiraterone, enzalutamide, or darolutamide. The study is testing if combining apalutamide, a standard treatment, with carotuximab, a new drug, is more effective than apalutamide alone. Researchers will look at how long patients live without their cancer getting worse (progression-free survival). The study will first check the safety of the drug combination in a small group of patients before moving to a larger group. The study aims to enroll 100 participants, but its current status is unclear.

Study design
This is an open-label, multi-site study, meaning both you and your doctors will know which treatment you are receiving. It will first assess safety in 10 participants before proceeding to a larger Phase II stage.
What's involved
Apalutamide is taken by mouth daily, and carotuximab is given through an IV on specific days during each 28-day cycle. The study will monitor your cancer progression until it worsens or you pass away, with follow-up for up to 30 days after treatment ends.
Compensation
Not stated in the trial record.
Follow-up
You will be followed from the start of treatment until your cancer progresses or you pass away, with an additional follow-up period of up to 30 days after your treatment ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05534646

Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Edwin Posadas, MD
~100 participants
Updated 2026-02-02 on ClinicalTrials.gov
What's tested:ApalutamideCarotuximab

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (rPFS) between patients receiving apalutamide and apalutamide + carotuximab
Measured over From the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.

Conditions

Castration-resistant Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

3 sites across 2 states
California2
Utah1

Study leadership

  • Edwin Posadas, MD FACP · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center

Who to contact

Clinical Trial Recruitment Navigator
[email protected]
3104232133
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

History of castration-resistant prostate cancer with rising PSA (prostate-specific antigen) on a contemporary ARSI (Androgen receptor (AR) signaling inhibitor: abiraterone, enzalutamide, darolutamide). Bicalutamide, nilutamide, and flutamide will not be considered as contemporary ARSIs
Patient must have had 1 and can have up to 2 prior AR targeted therapy with the exception of apalutamide.
Patients must decline or be ineligible for taxane therapy in the opinion of the treating physician.
All patients must agree to use an adequate method of contraception, in the opinion of the treating investigator, while on protocol treatment and for 3 months after the last dose of protocol treatment (apalutamide and/or carotuximab)

Exclusion

Non-PSA producing prostate cancers such as small cell prostate cancers or those prostate cancers which exhibit radiographic progression without PSA rise
Prior use of apalutamide
Other prior malignancy requiring active anticancer therapy
Prior exposure to carotuximab or any CD105 targeted antibody
Active bleeding or pathologic medical conditions that carries a high bleeding risk
A known diagnosis of Osler-Weber-Rendu syndrome

What this trial measures

  • Progression free survival (rPFS) between patients receiving apalutamide and apalutamide + carotuximabFrom the start of study treatment until documented progression, or death due to any cause, up to 30 days of follow-up after end of treatment.

    From the start of study treatment until documented progression, per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3, or death due to any cause.