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NCT06631521 · ClinicalTrials.gov registry record · Phase 1

Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer

A Phase 1 study of Prostate Cancer (Adenocarcinoma) and Prostate CA, sponsored by AdventHealth.

Recruiting
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT06631521 is a Phase 1 study of Prostate Cancer (Adenocarcinoma) and Prostate CA that is actively recruiting participants, run by AdventHealth. The registered enrollment target is 30 participants, below the 128-participant average among 13 other Prostate Cancer (Adenocarcinoma) trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06631521, a Phase 1 study of Prostate Cancer (Adenocarcinoma) and Prostate CA, is actively recruiting participants, sponsored by AdventHealth.

RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

The goal of this clinical trial is to determine the safety and feasibility of a new combination of darolutamide and relugolix as neoadjuvant therapy preceding radical prostatectomy (RP) for high-risk prostate cancer (PCa) in adult males.

Conditions Studied

Prostate Cancer (Adenocarcinoma) Prostate CA Prostate Cancer Surgery

Interventions

  • DRUG Darolutamide
  • DRUG Relugolix
  • PROCEDURE Radical Prostatectomy

Study Locations (1)

Florida

  • AdventHealth Orlando - Orlando

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2024-10-22
Est. Completion 2026-06
Phase Phase 1

Sponsor

AdventHealth

95 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06631521

The ClinicalTrials.gov registry entry for NCT06631521 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 128-participant average among 13 other Prostate Cancer (Adenocarcinoma) trials with a reported enrollment target (77% lower). The listed sponsor is AdventHealth, which has 95 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Prostate Cancer (Adenocarcinoma) appearing as the primary indexed condition, and to 3 interventions - of which Darolutamide is the first listed.

NCT06631521 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT06631521 about?

NCT06631521 is a clinical study titled "Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer". The goal of this clinical trial is to determine the safety and feasibility of a new combination of darolutamide and relugolix as neoadjuvant therapy preceding radical prostatectomy (RP) for high-risk prostate cancer (PCa) in adult males.

What is the current status of trial NCT06631521?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-10-22. Estimated completion is 2026-06.

What conditions does trial NCT06631521 study?

This clinical trial studies the following conditions: Prostate Cancer (Adenocarcinoma), Prostate CA, Prostate Cancer Surgery.

What interventions are being tested in trial NCT06631521?

The interventions under investigation include: Darolutamide (DRUG), Relugolix (DRUG), Radical Prostatectomy (PROCEDURE).

Who is sponsoring clinical trial NCT06631521?

This trial is sponsored by AdventHealth, which has 95 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06631521 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.