| Title: |
Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial. |
| Authors: |
Parker, CC; Kynaston, H; Cook, AD; Clarke, NW; Catton, CN; Cross, WR; Petersen, PM; Persad, RA; Pugh, CA; Saad, F; Logue, J; Payne, H; Bower, LC; Brawley, C; Rauchenberger, M; Barkati, M; Bottomley, DM; Brasso, K; Chung, HT; Chung, PWM; Conroy, R; Falconer, A; Ford, V; Goh, CL; Heath, CM; James, ND; Kim-Sing, C; Kodavatiganti, R; Malone, SC; Morris, SL; Nabid, A; Ong, AD; Raman, R; Rodda, S; Wells, P; Worlding, J; Parulekar, WR; Parmar, MKB; Sydes, MR; RADICALS investigators |
| Contributors: |
Parker, Christopher; James, Nicholas |
| Publisher Information: |
Elsevier BV |
| Publication Year: |
2024 |
| Collection: |
The Institute of Cancer Research (ICR): Publications Repository |
| Subject Terms: |
Humans; Male; Prostatic Neoplasms; Androgen Antagonists; Prostatectomy; Aged; Tosyl Compounds; Middle Aged; Anilides; Nitriles; Oligopeptides; Gonadotropin-Releasing Hormone; Prostate-Specific Antigen; Combined Modality Therapy; Drug Administration Schedule |
| Subject Geographic: |
England |
| Description: |
BACKGROUND: Previous evidence supports androgen deprivation therapy (ADT) with primary radiotherapy as initial treatment for intermediate-risk and high-risk localised prostate cancer. However, the use and optimal duration of ADT with postoperative radiotherapy after radical prostatectomy remains uncertain. METHODS: RADICALS-HD was a randomised controlled trial of ADT duration within the RADICALS protocol. Here, we report on the comparison of short-course versus long-course ADT. Key eligibility criteria were indication for radiotherapy after previous 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 add 6 months of ADT (short-course ADT) or 24 months of ADT (long-course ADT) to radiotherapy, using subcutaneous gonadotrophin-releasing hormone analogue (monthly in the short-course ADT group and 3-monthly in the long-course ADT group), 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 metastasis arising from prostate cancer or death from any cause. The comparison had more than 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 75% to 81% (hazard ratio [HR] 0·72). Standard time-to-event analyses were used. Analyses followed intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov, NCT00541047. FINDINGS: Between Jan 30, 2008, and July 7, 2015, 1523 patients (median age 65 years, IQR 60-69) were randomly assigned to receive short-course ADT (n=761) or long-course ADT (n=762) in addition to postoperative ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
Print-Electronic; 2425; application/pdf |
| Language: |
English |
| ISSN: |
1474-547X; 0140-6736 |
| Relation: |
S0140-6736(24)00549-X; The Lancet, 2024, 403 (10442), pp. 2416 - 2425; https://repository.icr.ac.uk/handle/internal/6357 |
| Availability: |
https://repository.icr.ac.uk/handle/internal/6357 |
| Rights: |
http://creativecommons.org/licenses/by/4.0/ |
| Accession Number: |
edsbas.8C26A7E1 |
| Database: |
BASE |