New drug cocktail aims to shrink prostate tumors before surgery

NCT ID NCT06631521

Recruiting now Disease control Sponsor: AdventHealth Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial is testing whether a combination of two hormone-blocking drugs (darolutamide and relugolix) can safely shrink high-risk prostate tumors before they are surgically removed. About 30 men with aggressive prostate cancer will take the drugs for a short time before their prostatectomy. The main goal is to check for safety and side effects, while also measuring how much the tumors shrink.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Darolutamide and Relugolix (oral hormone-blocking drugs)
What this could lead to: If it works, this could lead to a new way to shrink aggressive prostate tumors before surgery, potentially making the operation more effective.
What could go wrong: This is a very early (phase 1) trial with only 30 men, so the main goal is safety, not proof of benefit. The drug combo may cause side effects or not shrink tumors as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma prostate adenocarcinoma prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PROSTATE CA PROSTATE CANCER (ADENOCARCINOMA) PROSTATE CANCER SURGERY

Contacts and locations

Locations

AdventHealth Orlando
RECRUITING

Orlando, Florida, 32803, United States

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