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

NCT ID: NCT06627530

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-17
• Study Completion Date: 2026-09-30

Brief 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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Darolutamide + ADT leuprorelin

Group Type: EXPERIMENTAL

Darolutamide Oral Tablet

Intervention Type: DRUG

darolutamide 600 mg PO BID for 24 weeks

leuprorelin

Intervention Type: DRUG

leuprorelin depot 22.5 mg SC every 12 weeks

Darolutamide

Group Type: ACTIVE_COMPARATOR

Darolutamide Oral Tablet

Intervention Type: DRUG

darolutamide 600 mg PO BID for 24 weeks

Leuprorelin

Group Type: ACTIVE_COMPARATOR

leuprorelin

Intervention Type: DRUG

leuprorelin depot 22.5 mg SC every 12 weeks

Interventions

Darolutamide Oral Tablet

darolutamide 600 mg PO BID for 24 weeks

Intervention Type: DRUG

leuprorelin

leuprorelin depot 22.5 mg SC every 12 weeks

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Brazilian Clinical Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando C Maluf, MD

Role: STUDY_CHAIR

Brazilian Clinical Research Institute

Locations

Santa Casa de Misericórdia de Feira de Santana

Feira de Santana, Estado de Bahia, Brazil

Site Status: RECRUITING

Hospital Ophir Loyola

Belém, Pará, Brazil

Site Status: RECRUITING

Hospital São Marcos

Teresina, Piauí, Brazil

Site Status: ACTIVE_NOT_RECRUITING

Hospital de Clínicas Ijuí

Ijuí, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Hospital Universitário Pedro Ernesto

Rio de Janeiro, , Brazil

Site Status: RECRUITING

BP - A Beneficência Portuguesa de São Paulo

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Fernando C Maluf, MD

Role: CONTACT

maluffc@uol.com.br

+55 1159047339

Fernando Moura, MD

Role: CONTACT

fernando.moura0601@gmail.com

Facility Contacts

Hyrlana Passos

Role: primary

contato@hdpa.com.br

557536045500

Juliana Chaves

Role: primary

55 (91) 3122-7022

Leticia Y Castro

Role: primary

555533319300

Fabricio Borges Carrerete

Role: primary

comhupe@hupe.uerj.br

552128688000

Fabio Roberto Kater

Role: primary

fabiorkater@gmail.com

551135051000

Other Identifiers

001/2024

Identifier Type: -

Identifier Source: org_study_id