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Docetaxel and Prednisone added to Androgen Suppression and Radiation Therapy in Localized, High-Risk Prostate Cancer
NCT00288080Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2005
- Primary completion
- Apr 2014
- Countries
- 2
- Sponsor
- NRG Oncology
- Modality
- Small Molecules
- Drugs
- docetaxel
- Conditions
- prostate cancer (PCa)
01
Overview
Phase 3, randomised, open-label trial of docetaxel in prostate cancer (PCa) (2 arms), sponsored by NRG Oncology. Primary endpoint: Overall Survival at 4 years. Started Dec 2005; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Androgen suppression + Radiation Therapy
AS for 8 weeks followed by RT and concurrent AS. LHRH continues for 24 months.
Androgen suppression + Radiation Therapy + Chemotherapy
AS for 8 weeks followed by RT and concurrent AS. Following RT, 6 cycles of docetaxel and prednisone.
03
Who it enrols
Men with high-risk localized prostate cancer (defined by Gleason score and PSA), adequate organ function, and no prior definitive local therapy or systemic chemotherapy for prostate cancer.
04
Endpoints
Primary
Overall Survival
Secondary
Biochemical Control
Local Control
Distant Metastasis
Disease-free Survival
Incidence of Adverse Events
Time Interval Between Biochemical Failure and Distant Failure Respect to Testosterone Level
Validity of PSA Endpoint as a Surrogate for Overall Survival
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