A Phase III Study of Neoadjuvant Docetaxel and Androgen Suppression Plus Radiation Therapy Versus Androgen Suppression Alone Plus Radiation Therapy for High-Risk Localized Adenocarcinoma of the Prostate (DART)
- To compare disease-free survival rates in patients with high-risk localized
adenocarcinoma of the prostate treated with androgen suppression therapy and
radiotherapy with vs without docetaxel.
- To compare overall survival.
- To compare time to biochemical disease progression.
- To compare time to local disease progression.
- To compare time to distant disease progression.
- To compare time to next anticancer therapy.
- To compare progression-free survival.
- To compare degree of prostate-specific antigen (PSA) suppression prior to radiotherapy.
- To compare quality of life (QOL) using EORTC QLQ C30 and EORTC QLQ PR25 questionnaires
and a trial-specific checklist.
- To compare the nature, severity, and frequency of adverse events.
OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≤
7 vs ≥ 8), baseline prostate-specific antigen (PSA) (> 20 ng/mL vs ≤ 20 ng/mL), and
participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive androgen suppression therapy comprising oral flutamide three
times daily or oral bicalutamide once daily for 4 weeks AND leuprolide subcutaneously
(SC) or intramuscularly every 1-6 months, buserelin SC every 2 or 3 months, or
goserelin SC every 1 or 3 months for 3 years. Patients also receive docetaxel IV over
60 minutes on day 1. Treatment with docetaxel repeats every 21 days for up to 4
courses. Beginning at least 4 weeks after completion of chemotherapy, patients undergo
pelvic radiotherapy once daily 5 days a week for up to 8 weeks.
- Arm II: Patients receive androgen suppression therapy and undergo pelvic radiotherapy
as in arm I.
Patients complete quality of life questionnaires at baseline, periodically during treatment,
and then every 6 months for 5 years.
After completion of study treatment, patients are followed at 3 and 6 months, every 6 months
for 5 years, and then annually thereafter.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Michael R. McKenzie, MD, FRCPC
British Columbia Cancer Agency
Canada: Health Canada