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Trial · Interventional

Active, not recruitingPhase 4Registry data

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

Short name COAction

NCTNCT06627530 (opens ClinicalTrials.gov in a new tab)Other id001/2024
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 4
Enrollment
144 participants (estimated)
Sponsor
Brazilian Clinical Research Institute · Other
Design
Randomized · Single masking
Countries
1 country

Brazil

Start
17 Feb 2025
Primary completion
Mar 2026 (estimated)
Completion
Sept 2026 (estimated)
First posted
4 Oct 2024
Last update posted
11 Feb 2026
Conditions
Prostate Cancer

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027
  1. Ph 4

    COAction

    NCT06627530

    17 Feb 2025 to est. Sept 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

A Randomized Trial of Neoadjuvant Leuprorelin, Darolutamide or Both Prior to Radical Prostatectomy for Intermediate or High-risk Prostate Cancer. Prospective, randomized, parallel group, open-label with blinded endpoint adjudication multicenter clinical trial.To assess, among patients with unfavorable intermediate to high-risk prostate cancer, whether a neoadjuvant combined treatment with leuprorelin (Leuprorelin) and darolutamide is superior to monotherapy in terms of complete or almost complete pathological response.A total of 144 patients with unfavorable intermediate to high-risk prostate cancer scheduled for radical prostatectomy with extended pelvic lymph node dissection will be randomized 1:1:1 to oral darolutamide, SC leuprorelin (Leuprorelin) or both (48 patients per arm) for 24 weeks.

Interventions

  • Darolutamide Oral TabletDrug
  • leuprorelinDrug

Arms3

  • Experimental

    Darolutamide + ADT leuprorelin

  • Active comparator

    Darolutamide

  • Active comparator

    Leuprorelin

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Proportion of patients with minimal residual disease

    Time frame · 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.

    Registry description

    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 outcomes(9)

  1. Complete biochemical response assessed by serum PSA with the rate of PSA<0,2 ng/dL

    Time frame · 24 weeks

  2. Treatment emergent adverse events and serious adverse events.

    Time frame · 24 weeks

  3. PSA levels at 3 months after prostatectomy.

    Time frame · in 42 weeks

  4. Testosterone levels.

    Time frame · in 42 weeks

  5. Number of positive lymph nodes.

    Time frame · 30 weeks

  6. Number of positive surgical margins.

    Time frame · 30 weeks

  7. Perioperative complications.

    Time frame · 42 weeks

  8. Quality of life using IEEF5 and HRQoL questionnaires pre and post neoadjuvant treatment.

    Time frame · 42 weeks

  9. Downstaging (changes in TNM - Classification of Malignant Tumours stage) based on surgical specimen.

    Time frame · 30 weeks

    Registry description

    Prostate cancer TNM (Classification of Malignant Tumours) staging AJCC (American Joint Committee on Cancer) UICC (Union for International Cancer Control) 8th edition

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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; * Unfavorable intermediate-risk: * ISUP grade 3, and/or \> 50% positive biopsy cores and/or at least two intermediate-risk factors. Intermediate-risk factors: * Clinical tumor stage T2b or T2c (MRI based); * ISUP grade 2 or 3; * Prostate-specific antigen (PSA) level of 10-20 ng/mL. * High-risk or very high-risk: * ≥cT3a (MRI based) or ISUP 4-5 or PSA\>20 ng/mL; * cN1. * ECOG 0-1; * Baseline testosterone \> 230 ng/dL; * No prior prostate cancer treatment; * Sexually active male subjects must agree to use condoms as an effective barrier method and refrain from sperm donation, and/or their female partners of reproductive potential to use a method of effective birth control, during the treatment with darolutamide and for 1 week after the end of treatment with darolutamide to prevent pregnancy; * Written informed consent. Exclusion Criteria: * Unresectable prostate cancer; * Histology of small cell carcinoma prostate cancer or adenocarcinoma with neuroendocrine features; * Any prior prostate cancer treatment; * Any active infection requiring IV antibiotics; * Known additional malignancy that has a life-expectancy \< 2 years; * Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, heart failure with New York Heart Association Class Functional III or IV; * Uncontrolled severe hypertension as indicated by a resting systolic BP ≥ 180 mmHg or diastolic BP ≥ 110 mmHg despite medical management; * A gastrointestinal (GI) disorder or procedure which is expected to interfere significantly with absorption of darolutamide; * Inability to swallow oral medications; * Receipt of medications (e.g. finasteride, dutasteride) or agents that are likely to alter serum PSA levels within \<= 42 days or 5 half-lives prior to registration, whichever is shorter.

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