Patients suffering from prostate carcinoma with progression under first line hormonal treatment. Patients entering the study should have a life expectancy prognosis of at least 6 months. MedDRA version: 12.1 Level: LLT Classification code 10007453 Term: Carcinoma of the prostate metastatic
Conditions
Interventions
Product Name: 4 Phenyl-butyrate
Product Code: LU901
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: 4 Phenyl butyrate
Current Sponsor code: LU901
Concentration unit: mg milligram(s)
Sponsors
Lunamed Operations AG
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - To assess quality of life (patient questionnaire);Primary end point(s): Tumor progression | — |
Countries
Germany
Outcome results
None listed