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Updated: Jan 17, 2026
A Bioluminescent and Fluorescent Orthotopic Syngeneic Murine Model of Androgen-dependent and Castration-resistant Prostate Cancer
Published on: March 6, 2018
Comparing the safety and efficacy of systemic therapies for high-risk biochemically recurrent hormone-sensitive
Armen Aprikian1, Andrew Chilelli2, Thomas McLean2
1McGill University, Montreal, QC, Canada.
Introduction:
Enzalutamide is the only androgen receptor pathway inhibitor approved by the United States Food and Drug Administration and the European Medicines Agency to treat high-risk biochemically recurrent non-metastatic hormone-sensitive prostate cancer. The objective of this network meta-analysis was to provide indirect evidence of the efficacy of enzalutamide relative to other therapies for biochemical recurrence after definitive therapy.
Materials And Methods:
We conducted a systematic literature review to identify trials that assessed the efficacy and safety of current and emerging interventions. Outcomes of interest were metastasis-free survival, overall survival, time to prostate-specific antigen progression, time to castration resistance, proportion of patients with prostate-specific antigen <0.2 ng/ml at 36 (± 4) weeks of treatment, and grade ≥3 treatment-related adverse events. Fixed- and random-effects models were run under the Bayesian framework.
Results:
Enzalutamide with androgen-deprivation therapy (i.e., combination therapy) demonstrated superiority over most comparators for overall survival (except androgen-deprivation therapy + docetaxel, which was similar), and over all comparators for metastasis-free survival, time to prostate-specific antigen progression, and time to castration resistance. Enzalutamide combination therapy demonstrated superiority over enzalutamide monotherapy for all efficacy outcomes, and similar performance for safety. Enzalutamide monotherapy demonstrated superiority over androgen-deprivation therapy alone and androgen-deprivation therapy + docetaxel for metastasis-free survival and time to prostate-specific antigen progression. Treatment-related adverse events were least common for androgen-deprivation therapy alone.
Discussion:
This network meta-analysis provides evidence that enzalutamide combination therapy provides considerable oncological benefit in high-risk biochemically recurrent non-metastatic hormone-sensitive prostate cancer, albeit with a higher risk of treatment-related adverse events.
Insights
Enzalutamide combination therapy significantly improves survival and delays progression in high-risk prostate cancer. While effective, it carries a higher risk of adverse events compared to other treatments.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Enzalutamide is FDA/EMA-approved for high-risk biochemically recurrent non-metastatic hormone-sensitive prostate cancer.
- Evaluating enzalutamide's comparative efficacy against other therapies is crucial for treatment decisions.
Purpose of the Study:
- To conduct a network meta-analysis comparing enzalutamide-based therapies with other interventions for biochemically recurrent prostate cancer.
- To provide indirect evidence on the efficacy and safety of enzalutamide relative to standard treatments.
Main Methods:
- Systematic literature review of relevant clinical trials.
- Bayesian network meta-analysis using fixed- and random-effects models.
- Inclusion of outcomes: metastasis-free survival, overall survival, PSA progression, castration resistance, and adverse events.
Main Results:
- Enzalutamide combination therapy showed superiority in overall survival and metastasis-free survival compared to most comparators.
- Enzalutamide monotherapy demonstrated improved metastasis-free survival and time to PSA progression versus androgen-deprivation therapy alone.
- Androgen-deprivation therapy alone had the lowest incidence of treatment-related adverse events.
Conclusions:
- Enzalutamide combination therapy offers substantial oncological benefits for high-risk prostate cancer patients.
- The enhanced efficacy of enzalutamide combination therapy is associated with an increased risk of adverse events.
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