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Updated: Feb 13, 2026
Generation of Prostate Cancer Cell Models of Resistance to the Anti-mitotic Agent Docetaxel
Published on: September 8, 2017
A randomized phase II study of pelareorep and docetaxel or docetaxel alone in men with metastatic castration
Bernhard Josef Eigl1, Kim Chi1, Dongsheng Tu2
1BC Cancer Agency, Vancouver, BC, Canada.
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.
Insights
Adding pelareorep to docetaxel chemotherapy for prostate cancer did not improve outcomes. This combination was tolerable but showed inferior survival and response, suggesting it is not a viable treatment option.
Area of Science:
- Oncology
- Virology
- Clinical Trials
Background:
- Pelareorep, an oncolytic virus, demonstrates activity across various cancers, including prostate cancer.
- Preclinical studies indicate pelareorep exhibits in vitro synergy with microtubule-targeted agents.
Purpose of the Study:
- To evaluate the efficacy and safety of pelareorep in combination with docetaxel for patients with metastatic castration-resistant prostate cancer (mCRPC).
- To assess the 12-week lack of disease progression rate as the primary endpoint.
Main Methods:
- A randomized, open-label, phase II study enrolled 85 patients with mCRPC.
- Patients received docetaxel (75mg/m²) and prednisone, with either pelareorep (arm A) or without (arm B) for 21-day cycles.
- The primary endpoint was the 12-week lack of disease progression (LPD) rate.
Main Results:
- The 12-week LPD rate was 61% in the pelareorep arm (A) versus 52.4% in the control arm (B) (p=0.51).
- Median survival was 19.1 months for arm A and 21.1 months for arm B (HR 1.83; p=0.06).
- Adverse events were more frequent in the pelareorep combination arm.
Conclusions:
- Pelareorep in combination with docetaxel was tolerable but did not demonstrate a survival benefit in mCRPC patients.
- The combination showed comparable 12-week LPD rates but inferior response and survival outcomes.
- This combination strategy does not warrant further investigation.
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