Clinical trial · Interventional
COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer
A Randomized Trial of Neoadjuvant Leuprorelin, Darolutamide or Both Prior to Radical Prostatectomy for Intermediate or High-risk Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Darolutamide Oral Tablet | Drug | Darolutamide | ALIAS |
| leuprorelin | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Darolutamide + ADT leuprorelin
- interventionNames
- Drug: Darolutamide Oral Tablet
- Drug: leuprorelin
- type
- ACTIVE_COMPARATOR
- label
- Darolutamide
- interventionNames
- Drug: Darolutamide Oral Tablet
- type
- ACTIVE_COMPARATOR
- label
- Leuprorelin
- interventionNames
- Drug: leuprorelin
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.References
Publications (0)
Data not yet available