Randomised Trial of Adjuvant Radiotherapy Following Radical Prostatectomy Versus Radical Prostatectomy Alone in...

Area of Science:

• Oncology
• Radiation Oncology
• Surgical Oncology

Background:

• Uncertainty exists regarding the benefits of adjuvant radiotherapy for prostatectomy patients with positive surgical margins or extracapsular extension.
• Radical prostatectomy is a primary treatment for localized prostate cancer, but recurrence can occur.

Purpose of the Study:

• To compare the effectiveness and tolerability of adjuvant radiotherapy versus observation after radical prostatectomy.
• To evaluate the impact of adjuvant radiotherapy on biochemical recurrence-free survival and overall survival.

Main Methods:

• A randomized, open-label, parallel-group trial involving 250 patients with specific prostate cancer criteria (pT2 positive margins or pT3a, pN0, M0 without seminal vesicle invasion).
• Patients were assigned to receive adjuvant radiotherapy (66.6Gy) or observation.
• Biochemical recurrence-free survival was the primary endpoint, analyzed using Kaplan-Meier and Cox regression; secondary endpoints included overall survival, cancer-specific survival, local recurrence, and adverse events.

Main Results:

• The 10-year biochemical recurrence-free survival was significantly higher in the adjuvant radiotherapy group (82%) compared to the observation group (61%) (HR 0.26, p<0.001).
• Overall survival showed no significant difference between groups (92% vs. 87%, HR 0.69, p=0.4).
• Adjuvant radiotherapy was associated with a higher rate of grade 3 adverse events (56% vs. 40%, p=0.016), with one grade 4 event observed.

Conclusions:

• Adjuvant radiotherapy following radical prostatectomy is generally well-tolerated and extends biochemical recurrence-free survival in patients with positive margins or extracapsular extension.
• The findings support the use of adjuvant radiotherapy in selected prostate cancer patients to reduce recurrence risk, despite a higher rate of adverse events.