An Open Randomized Phase III Trial of Six Cycles of Docetaxel Versus Surveillance After Radical Prostatectomy in High Grade Prostate Cancer Patients With Margin Positive T2 or T3 Tumours
- Compare time to prostate-specific antigen (PSA) progression in patients with
margin-positive tumors after undergoing radical prostatectomy for high-grade prostate
cancer treated with docetaxel versus observation.
- Compare PSA doubling time in patients treated with these regimens.
- Compare quality of life of these patients.
- Compare overall and metastasis-free survival of patients treated with these regimens.
OUTLINE: This is a prospective, open-label, randomized, multicenter study. Patients are
stratified according to participating center and tumor stage (pT2 vs pT3). Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21
days for up to 6 courses in the absence of disease progression or unacceptable
Quality of life is assessed at baseline, directly after and 6 months after completing study
treatment, and then annually thereafter.
- Arm II: Patients undergo observation until PSA progression (defined as PSA ≥ 0.5 ng/mL)
Quality of life is assessed at baseline, week 19, and annually thereafter.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 396 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Prostate-specific antigen (PSA) progression
Goran Ahlgren, MD, PhD
Malmo University Hospital