COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer

What Was Tested

In this phase 4 trial, researchers set out to test Leuprolide.

A Randomized Trial of Neoadjuvant Leuprorelin, Darolutamide or Both Prior to Radical Prostatectomy for Intermediate or High-risk Prostate Cancer.

It had three arms (groups): Darolutamide + ADT leuprorelin (experimental), Darolutamide (active comparator) and Leuprorelin (active comparator).

The registry classes the interventions as drug.

Who Took Part

144 planned participants were the target.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Men ≥18 years of age;. Histologically confirmed unfavorable intermediate or high/very high risk non metastatic (by conventional imaging) prostate adenocarcinoma intended for surgery without neuroendocrine differentiation or small cell features;. ISUP grade 2 or 3;. Prostate-specific antigen (PSA) level of 10-20 ng/mL. High-risk or very high-risk:.

The full record lists 15 inclusion and 10 exclusion criteria; among the exclusions: unresectable prostate cancer;; histology of small cell carcinoma prostate cancer or adenocarcinoma with neuroendocrine features;; any prior prostate cancer treatment;.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Leuprolide group and the comparison group ran side by side rather than switching.

In this single-blind Leuprolide study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2025-02-17 with completion listed for 2026-03.

It ran at 6 sites in Brazil (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Proportion of patients with minimal residual disease.

It also tracked 9 secondary outcomes, for example Complete biochemical response assessed by serum PSA with the rate of PSA<0,2 ng/dL, Treatment emergent adverse events and serious adverse events, PSA levels at 3 months after prostatectomy, Testosterone levels, Number of positive lymph nodes and Number of positive surgical margins.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Leuprolide in 144 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.