Clinical trial NCT02288936 (phase 2, status: completed)
Conditions: hormone-refractory prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: enzalutamide
SMILES: CNC(=O)C1=C(F)C=C(C=C1)N1C(=S)N(C(=O)C1(C)C)C1=CC=C(C#N)C(=C1)C(F)(F)F
Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 18 years and above, willing and able to provide written informed
             consent.

          -  Prostate adenocarcinoma with histological or cytological confirmation without
             neuroendocrine differentiation nor small cell characteristics

          -  Androgen deprivation therapy with GnRH analogs or bilateral orchiectomy
             (pharmacological or surgical castration). Patients without bilateral orchiectomy must
             follow a GnRH analog therapy during the trial.

          -  Testosterone serum level <= 1,73 nmol/L (50 ng/dL) in screening visit.

          -  Patients under bisphosphonate therapy must have received stable doses for the last 4
             weeks.

          -  Progression disease at inclusion, defined by one or more of the following three
             criteria during androgen deprivation therapy (according with the criterion nº 3): -
             PSA progression defined as two elevation of the PSA serum level with >=1 week between
             each measure. Patients who have received an antiandrogen must present disease
             progression (>=4 weeks since the last dose of flutamide or >=6 weeks since the last
             dose of bicalutamide or nilutamide). PSA value in screening visit must be >=2 μg/L (2
             ng/mL). - Soft tissue progression defined by RECIST 1.1 criteria - Bone lesion
             progression defined by PCWG2 criteria, with two or more new lesions in a scintigraphy

          -  Metastatic disease with bone lesions detected by scintigraphy, or measurable soft
             tissue lesions by CT/MR. Patients with ganglionar disease will be suitable if they
             have at least one ganglionar lesion with smallest diameter > 2,5 cm.

          -  Patients without previous cytotoxic chemotherapy for prostate cancer

          -  Patients without previous abiraterone acetate therapy for prostate cancer - -
             Asymptomatic patient or mild symptomatic about prostate cancer, (answer in the
             question nº 3 of the Brief Pain Inventory Short From < 4) 11. ECOG = 0-1.

          -  Life expectancy of at least 6 months

          -  Patient must be able to swallow the investigation product and to follow the protocol
             requirements.

          -  Biomarker study informed consent

        Exclusion Criteria:

          -  Active infection or other medical condition which, in the opinion of the investigator,
             would preclude participation in this trial.

          -  Known brain metastasis or leptomeningeal active involvement

          -  Other malignancy in the last five years, except non-melanoma skin cancer treated and
             resolved.

          -  Hematologic parameters: - Absolute neutrophil count <=1500/μL - Platelet count <100
             000/μL - Haemoglobin < 5,6 mmol/L (9 g/dL)

          -  Liver function: Serum bilirubin, SGPT/ALT or SGOT/AST > 2,5 x ULN

          -  Renal function: Creatinine >177 μmol/L (2 mg/dL).

          -  Serum albumin <30 g/L (3,0 g/dL)

          -  History of epilepsy or other medical condition which could cause an epileptic crisis
             as syncope or transient ischemic attack in the last twelve months.

          -  Clinically significant cardiovascular disease.

          -  Known gastrointestinal (GI) disease that could interfere with the GI absorption.

          -  Significant surgery within 4 weeks before enrollment.

          -  Use of opioids to control cancer pain within 4 weeks before enrollment.

          -  Radiation therapy for treatment of the primary tumor in the last 3 weeks before
             enrollment

          -  Radiation therapy for treatment of metastases in the last two months

          -  Radionuclide therapy for treatment of bone metastasis

          -  Prior flutamide treatment within 4 weeks before enrollment

          -  Bicalutamide or nilutamide therapy within 6 weeks before enrollment

          -  5-a reductase inhibitors, estrogen o cyproterone therapy within 4 weeks before
             enrollment

          -  Biologic therapy or other antitumoral drugs for the treatment of CRPC in the last 4
             weeks

          -  History of cancer progression with ketoconazole

          -  Prior therapy or enrollment in a trial with an investigational product which blocks
             androgen synthesis (abiraterone, TAK-700, TAK-683, TAK-448) or blocks androgen
             receptors (ARN507, BMS 641988).

          -  Included in a previous trial with enzalutamide (MDV3100).

          -  Administration of an investigational drug in the last 4 weeks before enrollment

          -  Use of phytotherapy products which hormonal activity against prostate cancer or which
             reduce PSA levels, or systemic corticosteroids in a dose greater than the equivalent
             of prednisone 10mg/day, within 4 weeks before enrollment

          -  Hereditary fructose intolerance

          -  Any condition which, in the opinion of the investigator, would preclude participation
             in this trial.