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Updated: May 20, 2026

A Bioluminescent and Fluorescent Orthotopic Syngeneic Murine Model of Androgen-dependent and Castration-resistant Prostate Cancer
Published on: March 6, 2018
Challenges to improved therapeutics for metastatic castrate resistant prostate cancer: from recent successes and
Xuan Huang1, Cindy H Chau, William D Figg
1Medical Oncology Branch, National Cancer Institute, NIH, Bethesda, MD 20892, USA.
Abstract:
Men with metastatic castration-resistant prostate cancer (mCRPC) carry poor prognosis despite the use of docetaxel-based regimens which has modest survival benefit shown by randomized clinical trials. Significant progress in the discovery of novel therapeutic agents has been made in the past few years. While sipuleucel-T, cabazitaxel, and abiraterone gained regulatory approval in 2010 and 2011, several highly promising candidates/regimens have failed in large scale clinical trials. Challenges remain to optimize the design and interpretation of clinical trial results and develop more effective strategies for mCRPC. In this review, we examined the positive and negative clinical trials in mCRPC in the past and discussed the various aspects of clinical trial design including selection of targets and appropriate outcome measures, biomarker development and implementation, and strategies for combination therapy.
Insights
Despite new treatments, metastatic castration-resistant prostate cancer (mCRPC) remains challenging. This review examines past clinical trials to improve future mCRPC treatment strategies and trial design.
Area of Science:
- Oncology
- Clinical Trials
- Prostate Cancer Research
Background:
- Metastatic castration-resistant prostate cancer (mCRPC) presents a poor prognosis for men, even with docetaxel-based treatments.
- Recent advancements have introduced new therapies, yet many promising agents have failed in large clinical trials.
- Optimizing clinical trial design and interpretation is crucial for developing more effective mCRPC strategies.
Purpose of the Study:
- To review positive and negative clinical trials in mCRPC.
- To discuss key aspects of clinical trial design for mCRPC.
- To identify areas for improvement in mCRPC therapeutic development.
Main Methods:
- Systematic review of published randomized clinical trials in mCRPC.
- Analysis of clinical trial design elements: target selection, outcome measures, biomarkers, and combination therapies.
- Evaluation of factors contributing to trial success and failure.
Main Results:
- Docetaxel-based regimens offer modest survival benefits in mCRPC.
- Several novel agents approved between 2010-2011, but subsequent trials faced challenges.
- Clinical trial outcomes highlight the need for refined design and biomarker implementation.
Conclusions:
- Effective strategies for mCRPC require optimized clinical trial design.
- Biomarker development and implementation are critical for successful mCRPC drug development.
- Future research should focus on innovative trial designs and combination therapies for mCRPC.
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