|Title||Chiltern Sotio SP005|
|Principal Investigator/ Physician||David Clarkson, MD|
|Contact Email||MCI Clinical Trials|
Prostate Title: "A Randomized, Double Blind, Multicenter, Parallel-Group, Phase III Study to Evaluate Efficacy and Safety of DCVAC/PCa Versus Placebo in Men with Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line Chemotherapy."
Inclusion Criteria: Histologically or cytologically confirmed prostate adenocarcinoma; Presence of skeletal or soft-tissue/visceral/nodal metastasis; ECOG Performance status 0-2. Disease progression despite ADT as indicated by: PSA increase that is ≥ 2 mg/mL and ≥ 25% above the minimum PSA as reached during ADT or above the pre-treatment level OR Progression of measurable lymph nodes (≥ 15mm) or visceral lesion measurable
Exclusion Criteria: Confirmed brain and/or leptomeningeal metastases; Current symptomatic cord compression; Prior chemotherapy for prostate cancer; Treatment with anti-androgens, inhibitors of adrenal-produced androgens or other hormonal tumor-focused treatment performed on the day of screening or within previous four weeks
Clinical Trails.Gov Link: https://clinicaltrials.gov/ct2/show/NCT02111577?term=SP005&rank=1
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