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Timing of radiotherapy (RT) after radical prostatectomy (RP): long-term outcomes in the RADICALS-RT trial (NCT00541047)

Title: Timing of radiotherapy (RT) after radical prostatectomy (RP): long-term outcomes in the RADICALS-RT trial (NCT00541047)
Authors: Parker, CC; Petersen, PM; Cook, AD; Clarke, NW; Catton, C; Cross, WR; Kynaston, H; Parulekar, WR; Persad, RA; Saad, F; Bower, L; Durkan, GC; Logue, J; Maniatis, C; Noor, D; Payne, H; Anderson, J; Bahl, AK; Bashir, F; Bottomley, DM; Brasso, K; Capaldi, L; Chung, C; Cooke, PW; Donohue, JF; Eddy, B; Heath, CM; Henderson, A; Henry, A; Jaganathan, R; Jakobsen, H; James, ND; Joseph, J; Lees, K; Lester, J; Lindberg, H; Makar, A; Morris, SL; Oommen, N; Ostler, P; Owen, L; Patel, P; Pope, A; Popert, R; Raman, R; Ramani, V; Roder, A; Sayers, I; Simms, M; Srinivasan, V; Sundaram, S; Tarver, KL; Tran, A; Wells, P; Wilson, J; Zarkar, AM; Parmar, MKB; Sydes, MR
Source: Annals of Oncology , 35 (7) pp. 656-666. (2024)
Publisher Information: ELSEVIER
Publication Year: 2024
Collection: University College London: UCL Discovery
Subject Terms: Prostate cancer; radiotherapy; randomised controlled trial; clinical trial; observational; long-term follow-up
Description: BACKGROUND: 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 prostate-specific antigen (PSA) failure. PATIENTS AND METHODS: RADICALS-RT was a randomised controlled trial enrolling patients with ≥1 risk factor (pT3/4, Gleason 7-10, positive margins, preoperative PSA≥10 ng/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≥0.1 ng/ml or three consecutive rises. Stratification factors were Gleason score, margin status, planned RT schedule (52.5 Gy/20 fractions or 66 Gy/33 fractions) and treatment centre. The primary outcome measure was freedom-from-distant-metastasis (FFDM), designed with 80% power to detect an improvement from 90% with Salvage-RT (control) to 95% at 10 years with Adjuvant-RT. Secondary outcome measures were biochemical progression-free survival, freedom from non-protocol hormone therapy, safety and patient-reported outcomes. Standard survival analysis methods were used; hazard ratio (HR)
Document Type: article in journal/newspaper
File Description: text
Language: English
Relation: https://discovery.ucl.ac.uk/id/eprint/10197102/
Availability: https://discovery.ucl.ac.uk/id/eprint/10197102/1/Timing-of-radiotherapy-%28RT%29-after-radical-prostate.pdf; https://discovery.ucl.ac.uk/id/eprint/10197102/
Rights: open
Accession Number: edsbas.EA8A35DD
Database: BASE