Cabazitaxel With Radiation and Hormone Therapy for Prostate Cancer
Summary
This is a single-center, open-label, non-randomized Phase I study of weekly Cabazitaxel with concurrent intensity modulated radiation therapy (IMRT) (A type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles.) and androgen deprivation therapy (Treatment to suppress or block the production or action of male hormones) in patients with locally advanced prostate cancer. It is hoped that by adding Cabazitaxel to the standard IMRT, greater local disease control can be achieved and eventually the cure rate can be increased. After this study, the maximally tolerated dose of Cabazitaxel that could be used in combination with radiation can be found. Men with locally advanced high risk prostate cancer represent a group of patients for whom cure is potentially achievable utilizing a multimodality approach. More aggressive treatment upfront with chemotherapy and ADT may improve the long term disease control. We hypothesize that Cabazitaxel may be added to radiation therapy safely, and we anticipate that this novel approach will improve disease control and eventually improve survival for locally advanced prostate cancer patients.
Timeline
- Start
- 2011-09-22
- Primary completion
- 2015-07-21
- Completion
- 2020-07-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cabazitaxel | Other / unclassified | 2 mg/m2 | — |
| Subject | Cabazitaxel | Other / unclassified | 4 mg/m2 | — |
| Subject | Cabazitaxel | Other / unclassified | 6 mg/m2 | — |
| Subject | Cabazitaxel | Other / unclassified | 8 mg/m2 | — |
| Subject | Cabazitaxel | Other / unclassified | 10 mg/m2 | — |
| Background | Bicalutamide | Other / unclassified | — | Oral |