Reolysin Combined With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Metastatic Castration Resistant Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01619813|
Recruitment Status : Completed
First Posted : June 14, 2012
Last Update Posted : May 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Docetaxel, Reolysin and Prednisone Drug: Docetaxel and Prednisone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Study of Reolysin in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Castration Resistant Prostate Cancer|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||May 2016|
|Active Comparator: Docetaxel, Reolysin and Prednisone||
Drug: Docetaxel, Reolysin and Prednisone
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.
|Active Comparator: Docetaxel and Prednisone||
Drug: Docetaxel and Prednisone
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.
- Disease Progression [ Time Frame: 12 weeks ]Efficacy will be based on the lack of disease progression measured at 12 weeks.
- Effect of Docetaxel and Reolysin on circulating tumour cells [ Time Frame: 12 weeks ]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.
- PSA change rate [ Time Frame: 24 months ]
- Objective Response [ Time Frame: 24 months ]Objective response rate (in patients with measurable disease at baseline)
- Overall Survival [ Time Frame: 24 months ]
- Determine patient tolerability and toxicity of Reolysin and Docetaxel in combination [ Time Frame: 24 months ]Determine the effect of Reolysin and Docetaxel in combination in patients.
- Prognostic/Predictive molecular response [ Time Frame: 24 months ]Explore potential molecular factors which might be prognostic/predictive of response (tumour, CTCs, serial blood samples).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619813
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|BCCA - Abbotsford Centre|
|Abbotsford, British Columbia, Canada, V2S 0C2|
|BCCA - Cancer Centre for the Southern Interior|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|BCCA - Fraser Valley Cancer Centre|
|Surrey, British Columbia, Canada, V3V 1Z2|
|BCCA - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Centre of Southeastern Ontario at Kingston|
|Kingston, Ontario, Canada, K7L 5P9|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Ottawa Hospital Research Institute|
|Ottawa, Ontario, Canada, K1H 8L6|
|Allan Blair Cancer Centre|
|Regina, Saskatchewan, Canada, S4T 7T1|
|Study Chair:||Bernhard Eigl||BCCA Vancouver|