The purpose of this study is to find out if giving Reolysin in combination with docetaxel and prednisone can offer better results than standard therapy with docetaxel and prednisone.
Researchers doing this study also want to evaluate the side effects of Reolysin when given together with docetaxel and prednisone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Docetaxel 75 mg/m2 will be delivered as a 1-hour infusion q 3 weekly beginning on day 1, cycle 1. Reolysin will be delivered as a 1-hour infusion days 1-5. On day 1 of each cycle, when both agents are given, the docetaxel will be given first. Prednisone 5 mg BID will be given beginning day 1. Each cycle is 3 weeks in length.
Docetaxel 75 mg/m2 will be delivered as a 1-hour infusion q 3 weekly. Prednisone 5mg BID will be given beginning Day 1. Each cycle is 3 weeks in length.
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
BCCA - Abbotsford Centre
Abbotsford British Columbia, British Columbia, Canada
Disease Progression
Efficacy will be based on the lack of disease progression measured at 12 weeks.
Time frame: 12 weeks
Effect of Docetaxel and Reolysin on circulating tumour cells
Effect of docetaxel and Reolysin on the circulating tumour cell (CTC) favourable status (\< 5 CTC per 7.5mL). Effect will be measured after 6 and 12 weeks of treatment.
Time frame: 12 weeks
PSA change rate
Time frame: 24 months
Objective Response
Objective response rate (in patients with measurable disease at baseline)
Time frame: 24 months
Overall Survival
Time frame: 24 months
Determine patient tolerability and toxicity of Reolysin and Docetaxel in combination
Determine the effect of Reolysin and Docetaxel in combination in patients.
Time frame: 24 months
Prognostic/Predictive molecular response
Explore potential molecular factors which might be prognostic/predictive of response (tumour, CTCs, serial blood samples).
Time frame: 24 months
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BCCA - Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, Canada
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, Canada
London Regional Cancer Program
London, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
...and 1 more locations