Posted: Monday, October 23, 2023
Patients with prostate cancer who underwent radical prostatectomy did not appear to benefit from adjuvant radiotherapy, according to Noel Clarke, MBBS, FRCS, ChM, of Salford Royal Hospital and The Christie, Manchester, United Kingdom, and colleagues. The final results from the RADICALS-RT trial, which were presented during the European Society for Medical Oncology (ESMO) Congress 2023 (Abstract 1764O), also revealed an increased risk of both urinary and bowel morbidities with this intervention.
“The optimal timing of radiotherapy after radical prostatectomy for prostate cancer is uncertain,” the investigators remarked. “[Based on our findings,] an observation policy with salvage radiotherapy for prostate-specific antigen [PSA] failure should be the current standard.”
The investigators focused on 1,396 patients who underwent radical prostatectomy, had a postoperative PSA level of up to 0.2 ng/mL, and exhibited at least one of the following risk factors: pathologic T stage 3 or 4; Gleason score between 7 and 10; positive margins; or a preoperative PSA level of at least 10.0 ng/mL. Within 22 weeks after surgery, they were randomly assigned to receive either adjuvant radiotherapy (n = 697) or observation, with salvage radiotherapy given in the event of early PSA failure (defined as PSA level ≥ 0.1 ng/mL or three consecutive rises; n = 699). Follow-up data were provided for a median of 8 years.
With 80 events, the 10-year rate of freedom from distant metastases was 93% with adjuvant radiotherapy versus 90% with observation and salvage radiotherapy (hazard ratio [HR] = 0.68; P = .095). The 10-year rates of overall survival were 88% and 87%, respectively (HR = 0.98; P = .92). After 1 year, patients treated with adjuvant radiotherapy reported worse urinary and fecal incontinence (P < .001).
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