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Adjuvant Radiotherapy Provided No Benefit Among Patients With Prostate Cancer Post-Radical Prostatectomy
Final Results of RADICALS-RT Trial
Final Results of RADICALS-RT Trial
According to a phase 3 trial, adjuvant radiotherapy after radical prostatectomy provided no meaningful benefit among patients with prostate cancer.
These results were first presented by Noel Clarke, MD, The University of Manchester, UK, at the 2023 European Society for Medical Oncology Annual Congress in Madrid, Spain.
In this trial, 1396 patients with prostate cancer who had undergone radical prostatectomy were randomized to receive either adjuvant radiotherapy (n = 697) or observation with salvage radiotherapy upon PSA failure, defined as a PSA ≥0.1 ng/mL or 3 consecutive rises (n = 699). The primary outcome measure of this study was freedom from distant metastases (FFDM). Secondary outcome measures included overall survival, safety, and patient reported outcome measures at 1, 5, and 10 years.
Previously, the early outcome measure of biochemical progression-free survival were reported. In this analysis, the primary outcome measure of FFDM was reported.
The median follow-up duration was 8 years. In the observation arm, 39% underwent radiotherapy. The FFDM at 10 years was 93% in the adjuvant radiotherapy arm versus 90% in the observation arm (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.67 to 1.44; P = .92). Adjuvant radiotherapy arm was associated with an increased risk of urinary and bowel morbidity. Additionally, Dr Parker reported, “A large proportion of men randomized to early salvage [radiotherapy] did not need [radiotherapy] in the long term.”
Dr Clarke et al concluded, “An observation policy with salvage [radiotherapy] for PSA failure should be the current standard after [radical prostatectomy].”
Source:
Parker C, Clarke N, Cook A, et al. Timing of radiotherapy (RT) after radical prostatectomy (RP): Final results of RADICALS RT randomised controlled trial. Presented at the ESMO Annual Congress; October 20-24, 2023; Madrid, Spain. 1764O.
