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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 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.

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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.

Conditions Studied

Castration-resistant Prostate Cancer

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

FieldValue
Enrollment Target 100 participants
Start Date 2023-12-27
Est. Completion 2027-01
Phase Phase 2

Sponsor

Edwin Posadas, MD

3 total trials

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What the Registry Record Tells You About NCT05534646

The ClinicalTrials.gov registry entry for NCT05534646 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 211-participant average among 15 other Castration-resistant Prostate Cancer trials with a reported enrollment target (53% lower). The listed sponsor is Edwin Posadas, MD, which has 3 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.