📃 Paper Title: Timing of radiotherapy after radical prostatectomy (RADICALS-RT): a randomised, controlled phase 3 trial
🧍 Author: Christopher C Parker
🕒 Year: 2020
📚 Journal: Lancet
🌎 Country: United Kingdom
ㅤContext to the study:
Can you tell me about a study in which the data does not support the use of routine adjuvant chemotherapy following radical prostatectomy for prostate cancer?
ㅤ✅ Take-home message of study:
These initial results do not support routine administration of adjuvant radiotherapy after radical prostatectomy. Adjuvant radiotherapy increases the risk of urinary morbidity. An observation policy with salvage radiotherapy for PSA biochemical progression should be the current standard after radical prostatectomy.
ㅤ Multi-centre international phase 3 RCT.
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Study participants:
1396 patients at risk of recurrence after radical prostatectomy.
Recruitment: Nov 2007-Dec 2016.
Centres in 4 countries: Canada, Denmark, Ireland, UK
At least one risk factor of:
Pathological T-stage 3 or 4
Gleason score of 7-10
Positive margins
Preoperative PSA ≥10 ng/mL
Two arms:
Salvage radiotherapy (n=669) vs adjuvant radiotherapy (n=697)
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Key study outcomes:
Primary:
Freedom from distant metastases (FFDM):
Data for FFDM were not sufficiently mature (number of events observed was not yet near the target number of events) for comparison of randomised groups.
Others:
Biochemical progression-free survival:
85% in adjuvant radiotherapy group vs. 92% in salvage radiotherapy group (HR 0.88, 95% CI 0.58-1.33; p=0.53).
Freedom from non-protocol hormone therapy
Safety
Patient-reported outcomes:
Self-reported urinary incontinence was worse at 1-year for those in the adjuvant radiotherapy group (mean score 4.8 vs. 4.0; p=0.0023).
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Study Limitations:
Median follow up currently too short to reliably report long-term outcomes such as FFDM.
Changing salvage practices over time - e.g. hormone therapy now added to salvage radiotherapy.
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