Timing of Radiotherapy (RT) After Radical Prostatectomy (RP): Long-term outcomes in the RADICALS-RT trial [NCT00541047]

Ann Oncol. 2024 Apr 5:S0923-7534(24)00105-4. doi: 10.1016/j.annonc.2024.03.010. Online ahead of print.ABSTRACTBACKGROUND: The optimal timing of radiotherapy (RT) after radical prostatectomy for prostate cancer has been uncertain. RADICALS-RT compared efficacy and safety of adjuvant RT versus an observation policy with salvage RT for PSA failure.METHODS: RADICALS-RT was a randomised controlled trial enrolling patients with ≥1 risk factor (pT3/4, Gleason 7-10, positive margins, pre-op PSA≥10ng/ml) for recurrence after radical prostatectomy. Patients were randomised 1:1 to adjuvant RT ("Adjuvant-RT") or an observation policy with salvage RT for PSA failure ("Salvage-RT") defined as PSA≥0.1ng/ml or 3 consecutive rises. Stratification factors were Gleason score, margin status, planned RT schedule (52.5Gy/20 fractions or 66Gy/33 fractions) and treatment centre. The primary outcome measure was freedom-from-distant metastasis, designed with 80% power to detect an improvement from 90% with Salvage-RT (control) to 95% at 10yr with Adjuvant-RT. Secondary outcome measures were bPFS, freedom-from-non-protocol hormone therapy, safety and patient-reported outcomes. Standard survival analysis methods were used; HR<1 favours Adjuvant-RT.FINDINGS: Between Oct-2007 and Dec-2016, 1396 participants from UK, Denmark, Canada and Ireland were randomised: 699 Salvage-RT, 697 Adjuvant-RT. Allocated groups were balanced with median age 65yr. 93% (649/697) Adjuvant-RT reported RT within 6m afte...

Source: Cancer Control - April 7, 2024 Category: Cancer & Oncology Authors: C C Parker P M Petersen A D Cook N W Clarke C Catton W R Cross H Kynaston W R Parulekar R A Persad F Saad L Bower G C Durkan J Logue C Maniatis D Noor H Payne J Anderson A K Bahl F Bashir D M Bottomley K Brasso L Capaldi P W Cooke C Chung J Donohue B Eddy Source Type: research