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

Launched by BRAZILIAN CLINICAL RESEARCH INSTITUTE · Oct 3, 2024

Keywords

ClinConnect Summary

The COACTION Trial is a research study looking at new treatment options for men with intermediate to high-risk prostate cancer. The study aims to find out if taking a combination of two medications, leuprorelin and darolutamide, before surgery can help patients achieve better results compared to taking just one of these medications alone. In total, 144 men who meet specific criteria will be divided into three groups: one group will receive leuprorelin, another group will receive darolutamide, and the third group will receive both medications for 24 weeks before their scheduled surgery.

To be eligible for this trial, participants need to be men aged 18 and older with prostate cancer that has been confirmed through a biopsy and meets certain risk levels. They should not have received any prior treatment for prostate cancer and must agree to use condoms or other effective birth control methods during the study. Participants can expect close monitoring and support from the research team, and they will help researchers learn more about the effectiveness of these treatments in improving patient outcomes. This trial is not yet recruiting participants, so interested individuals will need to wait for further announcements.

Gender

MALE

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.