Non-Metastatic High-Risk Prostate Cancer Patients With Biochemical Relapse Only After Local Treatment. A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel
Docetaxel was shown to be active in metastatic hormone-refractory prostate cancer (PC) in
phase III trials (1-2). It is likely to demonstrate a substantial role in the management of
early-stage PC patients in the neoadjuvant and adjuvant settings, where clinical trials are
underway.•53% of all men who undergo radical prostatectomy will develop prostate-specific
antigen (PSA) elevations in the 10 years following surgery, with approximately 77% of these
recurrences occurring within the first 2 years.A prospective, multicenter, national,
randomized, two-arm, phase III study comparing hormonal treatment (LH-RH agonist alone) with
or without docetaxel was designed to evaluate the interest of chemotherapy in non-metastatic
prostate cancer patients at high risk of systemic recurrence after initial treatment
(radical prostatectomy or radiotherapy).
1. PETRYLAK DP, et al: Docetaxel and estramustine compared with mitoxantrone and
prednisone for advanced refractory prostate cancer. N Engl J Med 351:1513-1520, 2004
2. TANNOCK IF, de Wit R, Berry WR, et al: Docetaxel plus prednisone or mitoxantrone plus
prednisone for advanced prostate cancer. N Engl J Med 351:1502-1512, 2004
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint was the PSA (biochemical) progression-free survival (PFS) of high-risk metastasis-free PC patients, treated with LH-RH agonist for one year with or without docetaxel after prior radical prostatectomy (RP) or radiotherapy (RT).
Every month during 5 years.
Stephane Oudard, MD PhD
European Georges Pompidou Hospital
France: Ministry of Health