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NCT05534646 · ClinicalTrials.gov registry record · Phase 2
Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
A Phase 2 study of Castration-resistant Prostate Cancer, sponsored by Edwin Posadas, MD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 3
- Study locations
NCT05534646: Recruiting Phase 2 study of Castration-resistant Prostate Cancer, sponsored by Edwin Posadas, MD.
NCT05534646 is a Phase 2 study of Castration-resistant Prostate Cancer that is actively recruiting participants, run by Edwin Posadas, MD. The registered enrollment target is 100 participants, below the 211-participant average among 15 other Castration-resistant Prostate Cancer trials with a reported enrollment target (53% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05534646, a Phase 2 study of Castration-resistant Prostate Cancer, is actively recruiting participants, sponsored by Edwin Posadas, MD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 3
- Study locations
Study Summary
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). If the combination is deemed safe, the trial will proceed to the Phase II stage. The purpose of this study is to compare progression free survival (PFS) between patients receiving apalutamide and apalutamide + carotuximab using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3. The secondary objectives are to describe adverse events related to the intervention, overall response rate (ORR), proportion of patients resistant to apalutamide that benefit from the addition of carotuximab, and to determine the ORR, radiographic PFS, and biochemical PFS in the overall population.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Apalutamide
- DRUG Carotuximab
Study Locations (3)
California
- City of Hope - Duarte
- Cedars-Sinai Medical Center - Los Angeles
Utah
- Huntsman Cancer Institute and Hospital - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-12-27 |
| Est. Completion | 2027-01 |
| Phase | Phase 2 |
What NCT05534646 shows while recruiting
NCT05534646 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 211-participant average among 15 other Castration-resistant Prostate Cancer trials with a reported enrollment target (53% lower).
The record links to 1 condition, with Castration-resistant Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Apalutamide is the first listed.
NCT05534646 reports a single indexed study location in California, Utah.
Frequently Asked Questions
What is clinical trial NCT05534646 about?
NCT05534646 is a clinical study titled "Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer". 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). If the combination is deemed safe, the tr...
What is the current status of trial NCT05534646?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2023-12-27. Estimated completion is 2027-01.
What conditions does trial NCT05534646 study?
This clinical trial studies the following conditions: Castration-resistant Prostate Cancer.
What interventions are being tested in trial NCT05534646?
The interventions under investigation include: Apalutamide (DRUG), Carotuximab (DRUG).
Who is sponsoring clinical trial NCT05534646?
This trial is sponsored by Edwin Posadas, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05534646 being conducted?
This trial has 3 study locations across California, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Castration-resistant Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05534646's enrollment target sits among peer trials
100 6th of 15 higher than 10 of 15 other Castration-resistant Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Castration-resistant Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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