NCT01619813

Reolysin Combined With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Metastatic Castration Resistant Prostate Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Researchers doing this study also want to evaluate the side effects of Reolysin when given together with docetaxel and prednisone.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2012-12-14
• Primary completion: 2016-04-26
• Completion: 2016-05-20
• First posted: 2012-06-14
• Last updated: 2023-08-04

Locations

11 sites across 1 country: Canada