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Updated: Sep 30, 2026
A Bioluminescent and Fluorescent Orthotopic Syngeneic Murine Model of Androgen-dependent and Castration-resistant Prostate Cancer
Published on: March 6, 2018
New trial designs to assess antitumor and antiproliferative agents in prostate cancer
1Section Hematology/Oncology and Urology, Genitourinary Cancer Program, UC Cancer Research Center, University of Chicago, IL 60637, USA.
Abstract:
The discovery of multiple putative therapeutic targets and multiple putative agents for these targets in prostate cancer in the coming years poses significant challenges for clinical trial design. This is especially true for cytostatic agents that are not expected to lead to frank tumor shrinkage or declines in the PSA. The most promising agents will need to be identified early in their development. Since surrogate biologic markers are likely to play a critical role, the identification and validation of these markers is discussed. A number of non-traditional phase I and phase II clinical trial designs, including pre-operative dosing for assessing drug effect on a marker and the randomized discontinuation phase II design, are also discussed in detail. Use of such designs as well as surrogate marker validation will likely be required to efficiently choose appropriate agents for definitive study in the phase III setting.
Insights
Designing clinical trials for prostate cancer therapies presents challenges, especially for cytostatic agents. Innovative trial designs and validated surrogate markers are crucial for early identification of promising treatments.
Area of Science:
- Oncology
- Clinical Trial Design
- Prostate Cancer Therapeutics
Background:
- Multiple therapeutic targets and agents for prostate cancer are emerging.
- Cytostatic agents pose unique challenges in clinical trial design due to lack of tumor shrinkage or PSA decline.
- Early identification of promising agents is critical.
Purpose of the Study:
- To address challenges in clinical trial design for prostate cancer.
- To highlight the importance of surrogate biologic markers.
- To discuss non-traditional clinical trial designs for efficient agent selection.
Main Methods:
- Discussion of non-traditional Phase I and Phase II clinical trial designs.
- Exploration of pre-operative dosing for marker assessment.
- Detailed review of the randomized discontinuation Phase II design.
Main Results:
- Non-traditional designs can aid in assessing drug effects on markers.
- Validated surrogate markers are essential for efficient trial progression.
- These methods facilitate the selection of agents for Phase III studies.
Conclusions:
- Innovative clinical trial designs are necessary for advancing prostate cancer therapeutics.
- Surrogate marker validation is key to efficient drug development.
- Optimized trial strategies will accelerate the identification of effective treatments.
