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)

Condition	Intervention	Phase
Prostate Cancer	Drug: calcitriol  Drug: docetaxel	Phase III

Further study details as provided by Novacea:

Expected Total Enrollment:  900

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Male

Criteria

Inclusion Criteria:

• Histopathologically or cytologically proven adenocarcinoma of the prostate
• Documented metastatic prostate adenocarcinoma
• Documented progression while on androgen ablation therapy detected by rising PSA and/or imaging
• Age >= 18 years
• 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00273338

Alan Arroyo      (650) 228-1803    Arroyo@novacea.com
Tracey Ziomek      (650) 228-1867    Ziomek@novacea.com

Study chairs or principal investigators

Howard I. Scher, MD,  Study Chair,  Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan Kettering Cancer Center   
Kim N. Chi, M.D.,  Study Chair,  British Columbia Cancer Agency - Vancouver Centre   
Ronald De-Wit, M.D.,  Study Chair,  Erasmus University Medical Center (Netherlands)   

Study ID Numbers:  011-007
Last Updated:  January 6, 2006
Record first received:  December 14, 2005
ClinicalTrials.gov Identifier:  NCT00273338
Health Authority: United States: Food and Drug Administration; Canada: Health Canada
ClinicalTrials.gov processed this record on 2006-01-10