Status: Closed
Activation Date: 2012JUN11
Closing Date: 2015SEP25
Phase: II
Description: 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
Eligibility: Patients with a histological diagnosis of metastatic and/or locally recurrent castration resistant adenocarcinoma of the prostate. Tumour block available. Patients must be hormone refractory and have discontinued anti-androgens for at least 4 weeks prior to study entry. PSA >= 5 ng/mL at study entry. No prior chemotherapy for recurrent/metastatic disease. No prior docetaxel unless given adjuvantly and >= 12 months prior to enrollment. ECOG 0, 1 or 2. Adequate end-organ function.
Objective: 1. To evaluate efficacy which will be based on the lack of disease progression measured at 12 weeks. 2a. To determine the tolerability and toxicity of Reolysin and docetaxel when given in combination. 2b. To investigate additional potential measures of efficacy including CTC status, CTC conversion rate, change in PSA levels, Objective response rate and effect of both treatments on overall survival. 2c. Explore potential molecular factors predictive of response in archival tumour and baseline CTCs.
Participation: Limited to invited centres
Lay Description: The main purpose of this study is to discover if adding reolysin to standard chemotherapy (docetaxel/prednisone) is as effective as standard chemotherapy (docetaxel/prednisone) alone by looking at changes in PSA levels, CTCs and amount of disease. On both arms the docetaxel will be given by intravenous injection over 1 hr day 1 every three weeks and prednisone will be taken by mouth twice a day for 21 days. On the experimental arm, Reolysin will be given by intravenous injection over 1 hr on days 1-5 every three weeks, after the docetaxel infusion. Side-effects and safety of reolysin and docetaxel in combination will be monitored. Additional research will investigate tissue samples from previously removed prostate tissue.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| IND | I209 | 85 | 48 | 65 | 66 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| IND | I209 | 85 | 1 | 13 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| IND | I209 | 85 | 51 | 0 | 0 | 0 | 46 | 53 | 0 | 0 |