Randomised Trial of Adjuvant Radiotherapy Following Radical Prostatectomy Versus Radical Prostatectomy Alone in Prostate Cancer Patients with Positive Margins or Extracapsular Extension

Abstract

Background: It remains unclear whether patients with positive surgical margins or extracapsular extension benefit from adjuvant radiotherapy following radical prostatectomy. Objective: To compare the effectiveness and tolerability of adjuvant radiotherapy following radical prostatectomy. Design, setting, and participants: This was a randomised, open-label, parallel-group trial. A total of 250 patients were enrolled between April 2004 and October 2012 in eight Finnish hospitals, with pT2 with positive margins or pT3a, pN0, M0 cancer without seminal vesicle invasion. Intervention: A total of 126 patients received adjuvant radiotherapy at 66.6 Gy. Outcome measurements and statistical analysis: The primary endpoint was biochemical recurrence-free survival, which we analysed using the Kaplan-Meier method and Cox proportional hazard regression. Overall survival, cancer-specific survival, local recurrence, and adverse events were secondary endpoints. Results and limitations: The median follow-up time for patients who were alive when the follow-up ended was 9.3 yr in the adjuvant group and 8.6 yr in the observation group. The 10-yr survival for biochemical recurrence was 82% in the adjuvant group and

Observation with or without late radiotherapy is equivalent to early radiotherapy in high-risk prostate cancer after radical prostatectomy: A SEER-Medicare analysis on trends, survival outcomes and complications

“…Moreover, it should also be emphasized that 57.3% (70/122) in the observation group remained progression free [17]. Therefore, both our study and this recent trial support that observation followed by future radiation upon recurrence may provide an acceptable alternative to automatic early intervention with RT.…”

Adjuvant or early salvage radiotherapy for the treatment of localised and locally advanced prostate cancer: a prospectively planned systematic review and meta-analysis of aggregate data

“…Three trials, RADICALS-RT, GETUG-AFU 17 and RAVES were retained as being eligible for inclusion. Updated searches conducted in 2016 identified a further potentially eligible trial, however, this was subsequently excluded because it compared adjuvant RT to no RT, rather than with an early salvage policy (21). 6) and RADICALS-RT(5) trials were designed to assess whether ART was superior to SRT, the RAVES trial(7) was designed to assess whether SRT was non-inferior to ART in terms of biochemical failure.…”

Management of Persistently Elevated Prostate-specific Antigen After Radical Prostatectomy: A Systematic Review of the Literature

“…For these patients undergoing immediate sRT, the pre-sRT PSA level appeared as a surrogate for RT efficacy pleading for a rapid initiation of RT, as demonstrated in the postsurgery BCR setting [12,17,19]. The Finnish randomized trial of postoperative RT also reported a significant BCR advantage for postoperative RT in the context of adverse features after RP (HR 0.26, 10-yr recurrence-free survival 82% in the RT arm vs 61% in the control arm) [32]. As no specific subgroup analysis was performed according to the postoperative PSA value, this study was not included in this systematic review.…”