Combining apalutamide and carotuximab for advanced prostate cancer
Phase II Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
This study is testing if combining two drugs, apalutamide and carotuximab, can help men with advanced prostate cancer who haven't responded to other treatments feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Drugs / interventions | carotuximab |
| Locations | 3 sites (Duarte, California and 2 other locations) |
| Trial ID | NCT05534646 on ClinicalTrials.gov |
What this trial studies
This open-label, multi-site study evaluates the safety and efficacy of apalutamide combined with carotuximab in patients with metastatic, castration-resistant prostate cancer who have progressed on androgen receptor signaling inhibitors. The trial begins with a safety assessment in the first 10 subjects, followed by a Phase II evaluation comparing progression-free survival between those receiving apalutamide alone and those receiving the combination therapy. Secondary objectives include assessing adverse events, overall response rates, and the benefits of carotuximab for patients resistant to apalutamide.
Who should consider this trial
Good fit: Ideal candidates are patients with castration-resistant prostate cancer who have experienced rising PSA levels after treatment with contemporary androgen receptor signaling inhibitors.
Not a fit: Patients with non-PSA producing prostate cancers or those who have previously used apalutamide will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that improves progression-free survival for patients with advanced prostate cancer.
How similar studies have performed: Other studies have shown promise in combining therapies for advanced prostate cancer, but this specific combination is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Duarte, California and 2 other locations
- City of Hope — Duarte, California, United States (Recruiting)
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- Huntsman Cancer Institute and Hospital — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Edwin Posadas, MD FACP — Cedars-Sinai Medical Center
- Study coordinator: Clinical Trial Recruitment Navigator
- Email: cancer.trial.info@cshs.org
- Phone: 3104232133
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.