Is still there a place for orteronel in management of prostate cancer? Data from a literature based meta-analysis of randomized trials
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Updated: Mar 3, 2026

A Bioluminescent and Fluorescent Orthotopic Syngeneic Murine Model of Androgen-dependent and Castration-resistant Prostate Cancer
Published on: March 6, 2018
Giandomenico Roviello1, Chiara Pacifico2, Giorgio Chiriacò3
1Medical Oncology Unit, Department of Oncology, San Donato Hospital, Via Nenni 20, 52100 Arezzo, Italy; Department of Medical, Surgery and Health Sciences, University of Trieste, Piazza Ospitale 1, 34129 Trieste, Italy.
Abstract:
Orteronel (TAK-700) is an oral, non-steroidal 17,20-lyase inhibitor with higher specificity for 17,20 lyase over 17 hydroxylase. The first phase III studies showed an advantage with orteronel compared with placebo in terms of progression free survival and response of PSA. Unfortunately orteronel did not significantly prolong the overall survival. In order to assess the efficacy of orteronel in prostate cancer, we evaluated all available data on orteronel in the management of prostate cancer. A total of 2716 patients were evaluated from 3 randomized trials. We showed orteronel improved the progression free survival, time to PSA progression and PSA response compared with the placebo. In conclusion, given the limitations a literature rather than on individual patients' data meta-analysis, our data show a clinical efficacy of orteronel in prostate cancer, therefore we deem that orteronel may be investigated in combination with the other approved agents for CRPC or be tested in prior setting of disease such as the hormone sensitive prostate cancer.
Insights
Orteronel, a 17,20-lyase inhibitor, improved progression-free survival and PSA response in prostate cancer patients compared to placebo. While not extending overall survival, its clinical efficacy warrants further investigation in combination therapies.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Orteronel (TAK-700) is a selective oral non-steroidal 17,20-lyase inhibitor.
- Previous Phase III trials indicated benefits in progression-free survival and PSA response but not overall survival.
Purpose of the Study:
- To comprehensively assess the efficacy of orteronel in prostate cancer management.
- To evaluate pooled data from multiple randomized trials investigating orteronel.
Main Methods:
- Meta-analysis of data from 2716 patients across 3 randomized trials.
- Comparison of orteronel versus placebo for key efficacy endpoints.
Main Results:
- Orteronel significantly improved progression-free survival (PFS).
- Orteronel demonstrated enhanced time to PSA progression and higher PSA response rates.
- Overall survival benefit was not statistically significant in the analyzed trials.
Conclusions:
- Despite limitations of a literature-based meta-analysis, orteronel shows clinical efficacy in prostate cancer.
- Further research is recommended for orteronel in combination with other agents for castration-resistant prostate cancer (CRPC).
- Investigating orteronel in earlier disease stages, such as hormone-sensitive prostate cancer, is also suggested.
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