MedDRA version: 19.1 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Xtandi
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: ENZALUTAMIDE
CAS Number: 915087-33-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Sponsors
Fundación Canaria de Investigación Sanitarias
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. More than 18 years 2. Life expectancy> 10 years. 3. Diagnosis of prostate carcinoma, histologically confirmed 4. ECOG Score = 1. 5. Participants with an adequate organic function, defined as: A. Leukocytes =3,000 / mcL B. Platelets =80,000 / mcL C. Bilirubin Total =65 years) no F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Have received any investigational drug within 4 weeks prior to the start of the study treatment. 2. Prostate Cancer Stage T4 by clinical examination or radiologic evaluation. Hypogonadism or severe adrenal deficiency defined by testosterone screening 170 mmHg or diastolic BP> 105 mmHg in 2 consecutive measurements in the screening view; I. Electrocardiogram abnormalities that demonstrate toxicity equal to or greater than degree III toxicity according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. 11. Previous history of gastrointestinal disorders (medical conditions or extensive surgeries) that may interfere with adequate absorption of the drug within 3 months prior to enrollment. 12. Major surgery within 4 weeks prior to screening. 13. Prior use or participation in a clinical trial of an androgen-blocking investigational drug (eg, abiraterone acetate, TAK-700, TAK-683, TAK-448) or using as therapeutic targets androgen receptors . (E.j., enzyalutamide, BMS 641988), or prior use of ketoconazole. 14. Any condition that in the opinion of the investigator interferes with the patient's ability to participate in the trial, placing the patient at undue risk, or complicating the interpretation of the safety data. 15. The use of herbalist or alternative medicine that may affect the hormonal profile such as Prostasol or PC-SPES.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of the enzatulamide with hipofractioned radiotherapy in intermediate-risk localized prostet cáncer in relation with the reduction of the PSA levels.;Secondary Objective: Evaluate the induced modification by the enzatulamida in relation with: hormonal levels bone mineral density changes in the metabolic markers life quality safety and tolerability;Primary end point(s): PSA levels at the end of the treatment with enzalutamide and radiotherapy;Timepoint(s) of evaluation of this end point: at first month, week 25, third month and sixth month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): hormonal levels bone mineral density life quality safety and tolerability;Timepoint(s) of evaluation of this end point: hormonal levels : month 1, week 25, month3 and month 6. bone mineral density: week 25 safety and tolerability: first month later tan the last dose of enzalutamide and for the follow-up visits. | — |
Countries
Spain
Contacts
Public ContactServicio de Oncología radioterápica
Hospital Universitario Gran Canaria Dr Negrín
Outcome results
None listed