Post-operative External Radiotherapy Combined With Concomitant and Adjuvant Hormonal Treatment Versus Postoperative External Radiotherapy Alone in Pathological Stage pT3a-b R0-1 N0M0 / pT2R1 N0M0, Gleason Score 5-10 Prostatic Carcinoma. A Phase III Study
- To investigate the potential benefit of post-operative radiotherapy with vs without a
combined and adjuvant treatment consisting of short-term androgen suppression for
improving the biochemical progression-free survival of patients who have undergone
radical prostatectomy for stage I-III prostate cancer.
OUTLINE: This is a multicenter study. Patients are stratified according to institution,
pathological stage (pT2R1 vs pT3R0 vs pT3R1), Gleason sum (≤ 3+4 vs ≥ 4+3), and WHO
performance status (0 vs 1). Within 3 months after radical surgery, patients are randomized
to 1 of 2 treatment arms.
- Arm I: Patients undergo post-operative conformal external beam irradiation for 6.5
- Arm II: Beginning between days -5 to -3, patients receive an antiandrogen for 2-4
weeks. Beginning on day 0, patients receive leuprolide acetate subcutaneously once
(6-month depot) and undergo conformal external beam irradiation 5 times weekly for 6.5
Patients undergo quality of life assessments periodically.
After completion of study treatment, patients are followed up every 6 months for 5 years and
then yearly thereafter.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Biochemical progression-free survival
Michel Bolla, MD
CHU de Grenoble - Hopital de la Tronche