Timing of radiotherapy after radical prostatectomy (RADICALS-RT): a randomised, controlled phase 3 trial.
Abstract | BACKGROUND: METHODS: We did a randomised controlled trial enrolling patients with at least one risk factor (pathological T-stage 3 or 4, Gleason score of 7-10, positive margins, or preoperative PSA ≥10 ng/mL) for biochemical progression after radical prostatectomy (RADICALS-RT). The study took place in trial-accredited centres in Canada, Denmark, Ireland, and the UK. Patients were randomly assigned in a 1:1 ratio to adjuvant radiotherapy or an observation policy with salvage radiotherapy for PSA biochemical progression (PSA ≥0·1 ng/mL or three consecutive rises). Masking was not deemed feasible. Stratification factors were Gleason score, margin status, planned radiotherapy schedule (52·5 Gy in 20 fractions or 66 Gy in 33 fractions), and centre. The primary outcome measure was freedom from distant metastases, designed with 80% power to detect an improvement from 90% with salvage radiotherapy (control) to 95% at 10 years with adjuvant radiotherapy. We report on biochemical progression-free survival, freedom from non-protocol hormone therapy, safety, and patient-reported outcomes. Standard survival analysis methods were used. A hazard ratio (HR) of less than 1 favoured adjuvant radiotherapy. This study is registered with ClinicalTrials.gov, NCT00541047. FINDINGS: INTERPRETATION: FUNDING:
Cancer Research UK, MRC Clinical Trials Unit, and Canadian Cancer Society.
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Authors | Christopher C Parker, Noel W Clarke, Adrian D Cook, Howard G Kynaston, Peter Meidahl Petersen, Charles Catton, William Cross, John Logue, Wendy Parulekar, Heather Payne, Rajendra Persad, Holly Pickering, Fred Saad, Juliette Anderson, Amit Bahl, David Bottomley, Klaus Brasso, Rohit Chahal, Peter W Cooke, Ben Eddy, Stephanie Gibbs, Chee Goh, Sandeep Gujral, Catherine Heath, Alastair Henderson, Ramasamy Jaganathan, Henrik Jakobsen, Nicholas D James, Subramanian Kanaga Sundaram, Kathryn Lees, Jason Lester, Henriette Lindberg, Julian Money-Kyrle, Stephen Morris, Joe O'Sullivan, Peter Ostler, Lisa Owen, Prashant Patel, Alvan Pope, Richard Popert, Rakesh Raman, Martin Andreas Røder, Ian Sayers, Matthew Simms, Jim Wilson, Anjali Zarkar, Mahesh K B Parmar, Matthew R Sydes |
Journal | Lancet (London, England)
(Lancet)
Vol. 396
Issue 10260
Pg. 1413-1421
(10 31 2020)
ISSN: 1474-547X [Electronic] England |
PMID | 33002429
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2020 Elsevier Ltd. All rights reserved. |
Chemical References |
- Biomarkers, Tumor
- Prostate-Specific Antigen
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Topics |
- Adenocarcinoma
(pathology, radiotherapy, surgery)
- Aged
- Biomarkers, Tumor
(blood)
- Disease-Free Survival
- Humans
- Male
- Middle Aged
- Neoplasm Grading
- Proportional Hazards Models
- Prostate-Specific Antigen
(blood)
- Prostatectomy
- Prostatic Neoplasms
(pathology, radiotherapy, surgery)
- Radiotherapy, Adjuvant
- Salvage Therapy
- Survival Analysis
- Time Factors
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