Postoperative radiotherapy after radical prostatectomy: a randomised controlled trial (EORTC trial 22911)

Area of Science:

• Oncology
• Radiation Oncology
• Urologic Oncology

Background:

• Local cancer recurrence after prostatectomy is common in patients with extracapsular extension.
• Radical prostatectomy alone may not be sufficient for patients with positive surgical margins or pT3 tumors.
• A randomized controlled trial was conducted to evaluate the efficacy of immediate postoperative radiotherapy.

Purpose of the Study:

• To compare radical prostatectomy followed by immediate external irradiation versus prostatectomy alone.
• To assess the impact on biochemical progression-free survival in high-risk prostate cancer patients.
• To evaluate local control and toxicity associated with adjuvant radiotherapy.

Main Methods:

• 503 patients were randomized to a wait-and-see policy, and 502 to immediate postoperative radiotherapy (60 Gy).
• Eligible patients had pN0M0 tumors with pathological risk factors (capsule perforation, positive margins, seminal vesicle invasion).
• Biochemical progression-free survival served as the primary endpoint, with intention-to-treat analysis.

Main Results:

• Immediate postoperative radiotherapy significantly improved biochemical progression-free survival (74.0% vs 52.6%, p<0.0001).
• Clinical progression-free survival and locoregional failure rates were also significantly improved with irradiation.
• While Grade 2/3 late effects were more frequent, severe toxicity (Grade 3+) remained rare (4.2% vs 2.6%).

Conclusions:

• Adjuvant external irradiation post-prostatectomy enhances biochemical progression-free survival and local control.
• This strategy is beneficial for patients with positive surgical margins or pT3 prostate cancer at high risk of recurrence.
• Long-term data are necessary to determine the effect on overall survival.