hormone refraktory prostate cancer
Conditions
Interventions
Trade Name: Sutent
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Sunitinib
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
AKH Vienna
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Signed written informed consent - Male patients 18 years of age - WHO performance status of 0-2. - Histologically proven prostate adenocarcinoma. - All patients must have prostate adenocarcinoma that is unresponsive or refractory to androgen ablation with biochemical progression. - Measurable and/or evaluable progressive disease, which is defined as one of the following three criteria: • 25% increase in bidimensionally measurable soft tissue metastases • Appearance of new metastatic lesions (proven by CT scan,X-ray or bone scan) • PSA level at least 10 ng/mL, with increases on at least 2 successive occasions at least 2 weeks apart - Castrate level of testosterone (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Known brain metastases. - Peripheral neuropathy > grade 1 (according to NCI-CTC version 3.0). - Prior malignancy except the following: adequately treated basal cell or squamous cell skin cancer, or any other cancer from which the patient has been disease-free for >5 years. - Prior chemotherapy, radiotherapy, involving more than 25% of bone marrow producing area. (Prior use of Estramustine phosphate is allowed). - Active infection or known HIV. - Other serious illness or medical condition: unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry, active uncontrolled infection, peptic ulcer, unstable diabetes mellitus or other contraindications for the use of prophylactic corticosteroid medication. - Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening. - Presence of any psychological, familial, sociological, geographical condition hampering compliance with the study protocol and follow up schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate - whether CEC/CEP spikes induced by MTD docetaxel are suppressed by sunitinib in patients treated with docetaxel/sunitinib relative to docetaxel monotherapy ;Secondary Objective: The secondary objectives are to assess whether - whether docetaxel/sunitinib increase response rate and length of treatment holidays relative to docetaxel monotherapy - CEC/CEP remain suppressed by sunitinib maintenance therapy relative to patients receiving no sunitinib during chemotherapy treatment holidays - suppression of CEC/CEP by sunitinib co-treatment correlates with response rate and prolonged treatment holidays relative to patients receiving no sunitinib - whether serum angiogenesis biomarkers (i.e. VEGF, VEGFR, TSP1) and tumor biomarkers (i.e. Visfatin, SphP1) are suppressed by co- treatment with sunitinib and correlate with response rate and treatment holidays - whether treatment by sunitinib/docetaxel and sunitinib maintenance therapy in safe and tolerable ;Primary end point(s): Reduction of CEC/CEP | — |
Countries
Austria
Outcome results
None listed