1. There was no significant difference in metastasis-free survival between the ADT and non-ADT groups over 10 years.

2. Adverse events were comparable between both groups and no fatalities were reported.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Short-term androgen deprivation therapy (ADT) with primary adjuvant radiotherapy is known to improve metastasis-free survival in patients with intermediate-risk and high-risk localized prostate cancer. However, the benefit of ADT with postoperative radiotherapy after radical prostatectomy remains unclear. This randomized controlled trial aimed to evaluate the safety and efficacy of ADT with postoperative radiotherapy for the management of prostate cancer. The primary outcome was metastasis-free survival, defined as distant metastasis or all-cause mortality, while the key secondary outcome was ≥ grade 3 toxicity. According to study results, there were no significant differences in metastasis-free survival between the short-term ADT with postoperative radiotherapy and the radiotherapy-only group. Although this study was well done, it was limited by the absence of masking in the treatment allocation.

Click to read the study in The Lancet

Relevant Reading: Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer

In-depth [randomized controlled trial]: Between Nov 22, 2007, and Jun 29, 2015, 3965 patients were screened across 121 centers in Canada, Denmark, Ireland, and the UK. Included were patients with an indication for radiotherapy after radical prostatectomy, prostate-specific antigen (PSA) levels < 5 ng/mL, and absence of metastatic disease. Altogether, 1480 patients (743 in the ADT plus radiotherapy group and 743 in the radiotherapy-only group) were included in the final analysis. The primary outcome of metastasis-free survival showed no significant improvement with short-course ADT (10-year metastasis-free survival 79.2%, 95% confidence interval [CI] 75.4-82.5) versus radiotherapy alone (80.4%, 95% CI 76.6-83.6; Hazard ratio 0.89 (95% CI 0.668-1.140), p=0.35). The secondary outcome of grade 3 or higher toxicity was similar between groups (14% in ADT plus radiotherapy vs. 17% in radiotherapy alone, p=0.15). No fatalities were reported. Overall, findings from this study suggest that short-course ADT combined with postoperative radiotherapy does not improve metastasis-free survival in prostate cancer patients following radical prostatectomy.

Image: PD

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