Last updated 40 days ago
COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer
144 patients around the world
Available in Brazil
Brazilian Clinical Research Institute
3Research sites
144Patients around the world
This study is for people with
Prostate cancer
Requirements for the patient
From 18 Years
Male
Medical requirements
- Men ≥18 years of age.Histologically confirmed unfavorable intermediate or high/very high risk non metastatic 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.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.
- 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 or agents that are likely to alter serum PSA levels within <= 42 days or 5 half-lives prior to registration, whichever is shorter.
Sites
Hospital Universitario Pedro Ernesto
Recruiting
Hospital Ophir Loyola
Recruiting
Beneficência Portuguesa de São Paulo
Recruiting
StudyCOAction
SponsorBrazilian Clinical Research Institute
Study typeInterventional
Conditions
Prostate cancer
Requirements
From 18 YearsMale
Unique study IDclinicaltrials.gov
NCT06627530
