Enzalutamide and hypofractionated radiation therapy in intermediate-risk localized prostate cancer

Phase 1

• Conditions: MedDRA version: 19.1Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004617-25-ES
• Lead Sponsor: Fundación Canaria de Investigación Sanitarias

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-28
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

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 <2X upper limit of normality (ULN)
D. SGOT (AST) / SGPT (ALT) = 2.5 X LSN
and. Creatinine clearance = 60 ml / min or creatinine =2 x ULN
6. Potentially fertile patients should use effective contraceptive methods (barrier methods plus other contraceptive methods) before entering the study and during their participation in the study.
7. Patients must sign an informed consent document prior to enrollment in the study.
8. Patients should be available for clinical follow-up.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 50

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 <50ng / dL (ULN)
4. Prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer.
5. Concomitant use of androgens, anti-androgens, estrogens or progestogens within 6 months prior the enrollment or prior the use of finasteride or dutasteride within 30 days of screening.
6. Presence of any other malignant neoplasia, different from the current tumor, in the previous 5 years. Patients with skin cancer another than melanoma or superficial bladder cancer (Ta and TIS properly treated) will be accepted. Patients treated for any type of malignancy without relapse in a period of not less than 2 years are eligible for the study.
7. Uncontrolled intercurrent diseases, or co-morbidities including but not limited to active infectious processes, which the investigator deems inappropriate for enrollment in the study.
8. Previous history of convulsive episodes or medications that predispose to seizures.
9. History of syncope or transient ischemic attack within 12 months prior to enrollment.
10. Clinically significant cardiovascular disease including:
A. Acute myocardial infarction within 6 months prior to enrollment;
B. Unstable angina within 3 months prior to enrollment;
C. NYHA class 3 or 4 congestive heart failure (CHF), or history of NYHA 3 or 4 CHF in the past, unless an echocardiogram was performed within the previous 3 months with a ventricular injection fraction = 45%;
D. Previous history of clinically significant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, torsades de pointes);
E. Previous history of second-degree atrioventricular block type Mobitz II or third degree without permanent pacemaker;
F. Systolic hypotension defined as systolic BP <86 mmHg in 2 consecutive measurements in the screening view;
G. Bradycardia defined as heart rate <50 bpm in the screening view;
H. Uncontrolled hypertension defined as systolic BP> 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified