| Title: |
Adding 6 months of androgen deprivation therapy to postoperative radiotherapy for prostate cancer: a comparison of short-course versus no androgen deprivation therapy in the RADICALS-HD randomised controlled trial |
| Authors: |
Parker, Chris C.; Clarke, Noel W.; Cook, Adrian D.; Kynaston, Howard; Catton, Charles N. |
| Publisher Information: |
Elsevier |
| Publication Year: |
2025 |
| Collection: |
Cardiff University: ORCA (Online Research @ Cardiff) |
| Description: |
BackgroundPrevious evidence indicates that adjuvant, short-course androgen deprivation therapy (ADT) improves metastasis-free survival when given with primary radiotherapy for intermediate-risk and high-risk localised prostate cancer. However, the value of ADT with postoperative radiotherapy after radical prostatectomy is unclear.MethodsRADICALS-HD was an international randomised controlled trial to test the efficacy of ADT used in combination with postoperative radiotherapy for prostate cancer. Key eligibility criteria were indication for radiotherapy after radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to radiotherapy alone (no ADT) or radiotherapy with 6 months of ADT (short-course ADT), using monthly subcutaneous gonadotropin-releasing hormone analogue injections, daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as distant metastasis arising from prostate cancer or death from any cause. Standard survival analysis methods were used, accounting for randomisation stratification factors. The trial had 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 80% to 86% (hazard ratio [HR] 0·67). Analyses followed the intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov, NCT00541047.FindingsBetween Nov 22, 2007, and June 29, 2015, 1480 patients (median age 66 years [IQR 61–69]) were randomly assigned to receive no ADT (n=737) or short-course ADT (n=743) in addition to postoperative radiotherapy at 121 centres in ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| Relation: |
https://orca.cardiff.ac.uk/id/eprint/179241/1/1-s2.0-S0140673624005488-main.pdf; Parker, Chris C., Clarke, Noel W., Cook, Adrian D., Kynaston, Howard orcid:0000-0003-1902-9930 orcid:0000-0003-1902-9930 and Catton, Charles N. 2025. Adding 6 months of androgen deprivation therapy to postoperative radiotherapy for prostate cancer: a comparison of short-course versus no androgen deprivation therapy in the RADICALS-HD randomised controlled trial. The Lancet 403 (10442) , pp. 2405-2415. 10.1016/S0140-6736(24)00548-8 https://doi.org/10.1016/S0140-6736%2824%2900548-8 file https://orca.cardiff.ac.uk/id/eprint/179241/1/1-s2.0-S0140673624005488-main.pdf |
| DOI: |
10.1016/S0140-6736(24)00548-8 |
| Availability: |
https://orca.cardiff.ac.uk/id/eprint/179241/; https://doi.org/10.1016/S0140-6736(24)00548-8 |
| Rights: |
cc_by_4_0 |
| Accession Number: |
edsbas.6BAB7C4C |
| Database: |
BASE |