A randomized, double-blinded, multicentric phase II trial to optimize the treatment of the hormon refractory prostatic carcinoma in patients without preceding chemotherapy with Sorafenib + Docetaxel + Prednison vs. Placebo + Docetaxel + Prednison - A placebo controlled, randomized phase II trial with BAY 43-9006 (Sorafenib)

• Conditions: ocally progressed and / or metastasized hormon refractory prostate carcinoma; Classification code 10001203

• Registration Number: EUCTR2005-004378-25-DE
• Lead Sponsor: rologische Klinik und Poliklinik, Klinikum Großhadern der LMU München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-29
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

Main inclusion criteria

- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Metastasized adenocarcinoma of the prostate that is hormonrefractory, this means no more response to
hormon therapy, measured by a continous increase of Serum-PSA levels under preceded therapy
- Documented progression under the lastly aplied therapy (a definite increase of >20% that is confirmed by
two successive measurements with a time-lag of at least two weeks, or a 25% increase of measurable
lesions that are verified by radiologic examinations)
- Male patients > 18 years of age
- Preceded hormon therapy
- ECOG Performance Status = 1
- An adequate hematologic, renal, cardial and hepatic function according to the following parameters:

- Neutrophil count = 1500/mm3
- Thrombocytes = 100.000 mm/3
- Hemoglobine = 9 g/dl (6,2 mmol/l)
- Creatinine = 1,5 x of the upper limit of the normal range (ULN), oder Creatinine Plasma-Clearance = 45 ml/min
- Total bilirubin = 1,5 x ULN
- AST (SGOT) and ALT (SGPT) = 2,5 x ULN
- Alcalic Phosphatase = 5 x ULN
- Amylase und Lipase < 1,5 x ULN
- PT or INR and PTT < 1,5 x ULN
- Life expectancy = 12 weeks
- adequate methods of contraception of the male until three months
after the discontinuation of the Sorafenib therapy
- written informed consent and the right to discontinue the trial at any time without any consequences

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)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Main exclusion criteria

- Acquainted disorders of the calcium metabolism
- Curatively treated superficial TCC = 2 years without recidive
- Previous or recent neoplasies except for curatively treated in situ carcinomata and basal cell carcinomata of
the skin as well as curatively treated malignomata with no recurrence within the last 5 years
- Patients with brain tumors or metastases
- Existent peripheric neutropathies Grade 2
- Chronical diarrhoeas (now or in the anamnesis)
- Other severe concomitant diseases:

a) Patients with congestive heart insufficency; active angina pectoris or ischemia; myocardial infarctions
within 6 months prior to the trial initiation or patientes with severe cardial arrhythmias that require an
antiarrhythmic therapy (beta blockrs and digoxine are permitted)
b) Patients with uncontrolled blood pressure; systolic RR > 150 mm Hg or diastolic pressure > 90 mm Hg
despite optimal medical treatment
c) Patients with thrombotic or embolic events like apoplexia or lung embolia
d) Patients with recent or wellknown hemorrhagic diathesis
e) Wellknown significant neurological or psychiatrical disorders including dementia and epileptic seizures
f) Patients with severe infections (>Grade 2 NCI-CTC Version 3.0)
g) Ulcerations, unstable diabetes mellitus or other contraindications concerning the aplication of highly
dosed corticosteriods
h) Untreated vena-cava-syndrome
i) Wellknown ascites or pericard effusion
j) Wellknown symptomatic pleural effusion that has to be punctured
k) Infection with HIV or chronical Hepatits B or C
- Missing attendance or incapacity to observe the measures of treatment and examination
- Lack of compliance
Inadmissible therapies or drugs before or during the treatment with the study medication:
- Chemo- or Immunotherapy prior to the trial start
- Simultaneous treatment with additional antitumor therapies (such as
chemotherapy, immunotherapy, signal transduction inhibitors or hormone therapy)
except for bisphosphonates and LHRH antagonists in a constant dosage (at least
since four weeks prior to trial beginning) whereas this therapy should be continued
then
- Former treatment with experimental or approved angiogenesis inhibitors
- Radiation therapy during three weeks prior to the trial start
- Preceded radiation therapy if over 25% of the bone marrow were affected
- Major surgery, open biopsies or sigificant traumata during the last four weeks prior
to the trial start
- Severe wound healing disorders, ulcera or bone fractures during
the last four weeks prior to the trial start
- Patients with organ transplantations during the last four months prior to the trial start
- Preceded application of substances that target the ras – signal ways or EGFR
- Biologic response modifiers” e.g. G-CSF or GM-CSF within three weeks prior to the
trial start ( G-CSF and other hematopoetic growth factors are only to be applied for
the management of acute toxicities e.g. neutropenic fever if they are medically
indicated or according to the discretionary authority of the trial investigator)
- Participation in other clinical trials within 30 days prior to the therapy start
- Treatment with rifampicine or saint-john’s-wort (hypericum) during the trial
- Therapy with digitalis-glycosides or thiacid-diuretics

Study & Design

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