Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Brazilian Clinical Research Institute
With
Bayer
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer
