Prostate CancerPhase 4COActionNCT06627530
COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer
A Phase 4 study testing Darolutamide Oral Tablet and leuprorelin in people with Prostate Cancer, run by Brazilian Clinical Research Institute at 6 sites in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Darolutamide Oral Tablet and leuprorelin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 6 sitesBrazil
- Study dates
- 17 Feb 2025to Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to 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;
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
Hospital Ophir Loyola
Belém, Pará, 66063-240
Santa Casa de Misericórdia de Feira de Santana
Feira de Santana, Estado de Bahia, 44001-032
Hospital de Clínicas Ijuí
Ijuí, Rio Grande do Sul, 98700-000
Hospital Universitário Pedro Ernesto
Rio de Janeiro, 20551-030
BP - A Beneficência Portuguesa de São Paulo
São Paulo, 01323001
Hospital São Marcos
Teresina, Piauí, 64001-280
About this study
Official title: A Randomized Trial of Neoadjuvant Leuprorelin, Darolutamide or Both Prior to Radical Prostatectomy for Intermediate or High-risk Prostate Cancer
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.
- Conditions
- Prostate Cancer
- Being tested
- Darolutamide Oral Tablet, leuprorelin
- Keywords
- Prostate Cancer, Radical Prostatectomy, Darolutamide, Neoadjuvant
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darolutamide Oral TabletDrug
darolutamide 600 mg PO BID for 24 weeks
leuprorelinDrug
leuprorelin depot 22.5 mg SC every 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Darolutamide + ADT leuprorelin | Experimental | Not described Receives: Drug: Darolutamide Oral Tablet; Drug: leuprorelin |
| Darolutamide | Active comparator | Not described Receives: Drug: Darolutamide Oral Tablet |
| Leuprorelin | Active comparator | Not described Receives: Drug: leuprorelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with minimal residual disease
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.
Measured: 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.
Secondary outcomes (9)
Complete biochemical response assessed by serum PSA with the rate of PSA<0,2 ng/dL
Measured: 24 weeks
Treatment emergent adverse events and serious adverse events.
Measured: 24 weeks
PSA levels at 3 months after prostatectomy.
Measured: in 42 weeks
Testosterone levels.
Measured: in 42 weeks
Number of positive lymph nodes.
Measured: 30 weeks
Number of positive surgical margins.
Measured: 30 weeks
Perioperative complications.
Measured: 42 weeks
Quality of life using IEEF5 and HRQoL questionnaires pre and post neoadjuvant treatment.
Measured: 42 weeks
Downstaging (changes in TNM - Classification of Malignant Tumours stage) based on surgical specimen.
Prostate cancer TNM (Classification of Malignant Tumours) staging AJCC (American Joint Committee on Cancer) UICC (Union for International Cancer Control) 8th edition
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start17 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brazilian Clinical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Fernando C Maluf, MD, Study chair, Brazilian Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627530
- Sponsor's protocol ID
- 001/2024
- Acronym
- COAction
- Status last verified
- Feb 2026
- First submitted
- 12 Sep 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Neoadjuvant Leuprorelin, Darolutamide or Both Prior to Radical Prostatectomy for Intermediate or High-risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT06627530
- Acronym / sponsor ID
- COAction / 001/2024
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Radical Prostatectomy, Darolutamide, Neoadjuvant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Brazilian Clinical Research InstituteUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Darolutamide + ADT leuprorelin | Experimental | Drug: Darolutamide Oral Tablet, Drug: leuprorelin |
| Darolutamide | Active comparator | Drug: Darolutamide Oral Tablet |
| Leuprorelin | Active comparator | Drug: leuprorelin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- High-risk or very high-risk:
- ECOG 0-1;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Darolutamide Oral Tabletdarolutamide 600 mg PO BID for 24 weeks | Drug | Darolutamide, Darolutamide + ADT leuprorelin |
| leuprorelinleuprorelin depot 22.5 mg SC every 12 weeks | Drug | Darolutamide + ADT leuprorelin, Leuprorelin |
Primary outcome
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.
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.
9 secondary outcomes
Complete biochemical response assessed by serum PSA with the rate of PSA<0,2 ng/dL
Time frame: 24 weeks
Treatment emergent adverse events and serious adverse events.
Time frame: 24 weeks
PSA levels at 3 months after prostatectomy.
Time frame: in 42 weeks
Testosterone levels.
Time frame: in 42 weeks
Number of positive lymph nodes.
Time frame: 30 weeks
Number of positive surgical margins.
Time frame: 30 weeks
Perioperative complications.
Time frame: 42 weeks
Quality of life using IEEF5 and HRQoL questionnaires pre and post neoadjuvant treatment.
Time frame: 42 weeks
Downstaging (changes in TNM - Classification of Malignant Tumours stage) based on surgical specimen.
Time frame: 30 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando C Maluf, MD study chair
Brazilian Clinical Research Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Darolutamide Oral Tablet and leuprorelin in people with Prostate Cancer, run by Brazilian Clinical Research Institute at 6 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.