Clinical trial: Activity of Abiraterone Acetate in the Management of Cushing's Syndrome in Patients With Adrenocortical Carcinoma (NCT03145285)

Eligibility criteria:
Inclusion Criteria:

          -  Histologically-confirmed diagnosis of ACC

          -  CT or MRI evidence of metastatic or locally advanced ACC (ENSAT stage III-IV)
             unsuitable for radical surgery

          -  Age ≥ 18 years

          -  Confirmed diagnosis of Cushing's syndrome validated by:

          -  two 24 h urinary collections for UFC at least 1.5 times the upper the normal levels,
             within 2 weeks prior to enrollment;

          -  serum ACTH levels lower than the normal range;

          -  ECOG performance status ≤ 2

          -  Effective contraception

          -  Patients must provide verbal and written informed consent to be enrolled in the study

        Exclusion Criteria:

          -  Life expectancy less than 3 months

          -  Liver disease, such as cirrhosis, chronic or persistent active hepatitis or AST/ALT >
             2 x ULN, bilirubin >2 x ULN

          -  Heart failure (NYHA class III or IV), unstable angina, severe arrhythmia or clinically
             significant impairment of heart function

          -  Major surgical procedure within one month prior entering the study

          -  Renal impairment (creatinine clearance < 40 ml/min).

          -  WBC <3 x 109 /L; Hb <13 g/dL for men and <12 g/dL for women; platelets <100 x 109 /L

          -  Any other severe acute or chronic medical or psychiatric condition, or laboratory
             abnormality that would impart, in the judgment of the investigator, excess risk
             associated with study participation or study drug administration, or which, in the
             judgment of the investigator, would make the patient inappropriate for entry into this
             study.

          -  Pregnant or breast-feeding women

          -  History of alcohol or drug abuse

          -  History of recent or active prior malignancy, except for cured non-melanoma skin
             cancer, cured in situ cervical carcinoma, or other treated malignancies with no
             evidence of disease for at least three years)

          -  Acute or chronic uncontrolled infections

          -  Patient non-compliance
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old man comes to the office due to weight gain and fatigue.  He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father.  Blood pressure is 165/90 mm Hg and pulse is 85/min.  On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities.  Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit.  Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels.  Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome.

Patient description (patient's own words): I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome.

Does the patient match the trial criteria? 0