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. 2018 Jan 17;9(8):8155-8164.
doi: 10.18632/oncotarget.24263. eCollection 2018 Jan 30.

A randomized phase II study of pelareorep and docetaxel or docetaxel alone in men with metastatic castration resistant prostate cancer: CCTG study IND 209

Bernhard Josef Eigl  1 , Kim Chi  1 , Dongsheng Tu  2 , Sebastien J Hotte  3 , Eric Winquist  4 , Christopher M Booth  5 , Christina Canil  6 , Kylea Potvin  4 , Richard Gregg  2 , Scott North  7 , Muhammad Zulfiqar  1 , Susan Ellard  8 , Joseph Dean Ruether  9 , Lyly Le  10 , A Saranya Kakumanu  11 , Mohammad Salim  12 , Alison L Allan  4 , Harriet Feilotter  2 , Ashley Theis  2 , Lesley Seymour  2
Affiliations

A randomized phase II study of pelareorep and docetaxel or docetaxel alone in men with metastatic castration resistant prostate cancer: CCTG study IND 209

Bernhard Josef Eigl et al. Oncotarget. .

Abstract

Background: Pelareorep is an oncolytic virus with activity in many cancers including prostate. It has in vitro synergism with microtubule-targeted agents. We undertook a clinical trial evaluating pelareorep in mCRPC patients receiving docetaxel.

Patients and methods: In this randomized, open-label phase II study, patients received docetaxel 75mg/m2 on day 1 of a 21-day cycle and prednisone 5mg twice daily, in combination with pelareorep (arm A) or alone (arm B). The primary endpoint was 12 weeks lack of disease progression rate (LPD).

Results: Eighty-five pts were randomized. Median age was 69, ECOG performance status was 0/1/2 in 31%/66%/3% of patients. Bone/regional lymph node/liver metastases were present in 98%/24%/6%. The median prognostic score was slightly higher in Arm A (144 vs. 129 p= 0.005). Adverse events were as expected but more prevalent in arm A. The 12-week LPD rate was 61% and 52.4% in arms A/B (p=0.51). Median survival was 19.1 on Arm A and 21.1 months on Arm B (HR 1.83; 95% CI 0.96 to 3.52; p=0.06). No survival benefit of pelareorep was found.

Conclusion: Pelareorep with docetaxel was tolerable with comparable LPD in both arms but response and survival were inferior and so this combination does not merit further study.

Keywords: chemotherapy; clinical trial; oncolytic viruses; prostate cancer.

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Conflict of interest statement

CONFLICTS OF INTEREST LS declares the receipt of institutional support for the conduct of this study from Oncolytics Biotech, Inc. All other authors declare that they have no conflicts of interest.

Figures

Figure 1
Figure 1. CONSORT diagram outlining subject disposition
Figure 2
Figure 2. Overall survival
See this image and copyright information in PMC

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