Prostate Cancer
Conditions
Keywords
Androgen-independent Prostate Cancer (AIPC), Prostate Cancer, DN-101, calcitriol, Taxotere, docetaxel
Brief summary
The primary objective of this study is: * To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on survival in metastatic androgen-independent prostate cancer The secondary objectives of this study are: * To determine the effect of the ASCENT regimen on the rate of thromboembolic events (blood clots) * To determine the effect of the ASCENT regimen on prevention of skeletal-related events (fractures) * A Separate sub-study will be conducted at selected study sites in North America to determine the population PK of DN-101.
Interventions
DRUGcalcitriol
DRUGdocetaxel
Sponsors
Novacea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histopathologically or cytologically proven adenocarcinoma of the prostate * Documented metastatic prostate adenocarcinoma * Documented progression while on androgen ablation therapy detected by rising prostate specific antigen (PSA) and/or imaging * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status \<= 2 * Adequate hematologic, renal and hepatic function * Life expectancy \>= 3 months
Exclusion criteria
* Prior chemotherapy, except estramustine * Prior chemotherapy with docetaxel * Prior isotope therapy (e.g., strontium-89, samarium-153, etc.) * One or more contraindications to the use of corticosteroids * History of cancer-related hypercalcemia
Countries
Canada, Czechia, Germany, Hungary, Puerto Rico, Romania, Serbia and Montenegro, Slovakia, United States
Outcome results
None listed