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New treatment option for Castration-resistant Prostate Cancer
Official title Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT05534646
What this study is testing
What is Apalutamide?
Apalutamide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for castration-resistant prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, multi-site study of apalutamide with carotuximab in patients who have progressed on androgen receptor signaling inhibitor (ARSI) therapy. This study will begin with a safety assessment in the first 10 subjects (part 1: Safety Lead-in).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- History of castration-resistant prostate cancer with rising PSA (prostate-specific antigen) on a contemporary ARSI (Androgen receptor (AR) signaling...
- 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...
You likely can't join if
- Non-PSA producing prostate cancers such as small cell prostate cancers or those prostate cancers which exhibit radiographic progression without PSA...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Los Angeles, California, United States
- Salt Lake City, Utah, United States
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Los Angeles, California, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.