Trial · NCT06627530
COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer
NCT06627530, Phase 4, Active not recruiting, Brazilian Clinical Research Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer. Trials, record NCT06627530. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06627530
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer
- NCT number
- NCT06627530
- Status
- Active not recruiting
- Phases
- Phase 4
- Enrollment
- 144 participants, estimated
- Lead sponsor
- Brazilian Clinical Research Institute
- Conditions
- Prostate Cancer
- Interventions
- Darolutamide Oral Tablet, leuprorelin
- First posted
- 2024-10-04
- Last updated
- 2026-10-30
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients with minimal residual disease | Patients are expected to undergo surgery after no more than 30 days after completion of the neoadjuvant regimen therapy, which will last for 24 weeks after randomization in all 3 groups. | Proportion of patients with minimal residual disease, defined as residual cancer burden (RCB) ≤ 0.25 cm3 (tumor volume ≤ 0.5 cm3 × tumor cellularity ≤ 50%) or complete pathological response, assessed by pathology of surgical specimen obtained from prostatectomy. |
| Secondary | Complete biochemical response assessed by serum PSA with the rate of PSA<0,2 ng/dL | 24 weeks | |
| Secondary | Treatment emergent adverse events and serious adverse events. | 24 weeks | |
| Secondary | PSA levels at 3 months after prostatectomy. | in 42 weeks | |
| Secondary | Testosterone levels. | in 42 weeks | |
| Secondary | Number of positive lymph nodes. | 30 weeks | |
| Secondary | Number of positive surgical margins. | 30 weeks | |
| Secondary | Perioperative complications. | 42 weeks | |
| Secondary | Quality of life using IEEF5 and HRQoL questionnaires pre and post neoadjuvant treatment. | 42 weeks | |
| Secondary | Downstaging (changes in TNM - Classification of Malignant Tumours stage) based on surgical specimen. | 30 weeks | Prostate cancer TNM (Classification of Malignant Tumours) staging AJCC (American Joint Committee on Cancer) UICC (Union for International Cancer Control) 8th edition |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06627530
GET https://conductscience.org/api/trials/v1/NCT06627530/registered