A PILOT STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND EFFICACY OF A DAILY DOSE OF 500MG. LU901 (4PHENYL-BUTYRATE, CONTROLLED RELEASE TABLETS) IN ADDITION TO STANDARD HORMONAL TREATMENT IN PATIENTS WITH METASTASIZED PROSTATE CARCINOMA AND A LIFE EXPECTANCY OF AT LEAST 6 MONTHS.

Conditions: Patients suffering from prostate carcinoma with progression underfirst line hormonal treatment. Patients entering the study shouldhave a life expectancy prognosis of at least 6 months.
MedDRA version: 12.1Level: LLTClassification code 10007453Term: Carcinoma of the prostate metastatic

Registration Number: EUCTR2010-020681-16-DE

Lead Sponsor: unamed Operations AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

Patients with a confirmed diagnosis of prostate carcinoma, and measurable metastatic lesion(s).
Stage of the disease is T*any*,N*>1* and/or M*>1*, but with a life expectancy of at least 6 months under first-line hormonal treatment.
Patient must be at least 21 years of age.
Patients must be informed of the investigational nature of this study and must give written informed consent prior to the receiving of treatment per this protocol.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with life expectancy < 6 months.
Patients with hormonal treatment for prostate carcinoma, initiated within 3 months before start of the study.
Patients with non-hormonal treatment for their prostate cancer at study entry.
Included patients with rapidly progressive disease (based on clinical judgment of the investigator) requiring second-line treatment (e.g. chemo therapy) will drop out of the study. In case of progression within 6 months after entry into the study, the patient will be replaced, in case of progression after 6 months post-entry, the patient will be regarded as treatment failure.
Patients participating in another study protocol.
Any condition that would limit the ability to receive oral medication.
Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
Active second primary malignancy (except adequately treated basal cell carcinoma of the skin) within less than one year of enrollment into this study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the progression of the disease and the number of complete clinical responses (according to RECIST20) under treatment with LU901.;Secondary Objective: To assess safety and tolerability of treatment with 4PB<br>- To assess quality of life (patient questionnaire);Primary end point(s): Tumor progression

Secondary Outcome Measures