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Randomised Trial of No, Short-term, or Long-term Androgen Deprivation Therapy with Postoperative Radiotherapy After Radical Prostatectomy: Results from the Three-way Comparison of RADICALS-HD (NCT00541047)

Title: Randomised Trial of No, Short-term, or Long-term Androgen Deprivation Therapy with Postoperative Radiotherapy After Radical Prostatectomy: Results from the Three-way Comparison of RADICALS-HD (NCT00541047)
Authors: Parker, CC; Clarke, NW; Cook, AD; Petersen, PM; Catton, CN; Cross, WR; Kynaston, H; Persad, RA; Saad, F; Logue, J; Payne, H; Amos, C; Bower, L; Raman, R; Sayers, I; Worlding, J; Parulekar, WR; Parmar, MKB; Sydes, MR
Source: European Urology (2024) (In press).
Publisher Information: Elsevier BV
Publication Year: 2024
Collection: University College London: UCL Discovery
Subject Terms: Androgen deprivation therapy; Clinical trials; Duration; Hormone therapy; Multiarm trial; Prostate cancer; Radical prostatectomy; Radiotherapy; Randomised controlled trial
Description: BACKGROUND AND OBJECTIVE: The use and duration of androgen deprivation therapy (ADT) with postoperative radiotherapy (RT) have been uncertain. RADICALS-HD compared adding no (“None”), 6-months (“Short”), or 24-mo (“Long”) ADT to study efficacy in the long term. METHODS: Participants with prostate cancer were indicated for postoperative RT and agreed randomisation between all durations. ADT was allocated for 0, 6, or 24 mo. The primary outcome measure (OM) was metastasis-free survival (MFS). The secondary OMs included freedom from distant metastasis, overall survival, and initiation of nonprotocol ADT. Sample size was determined by two-way comparisons. Analyses followed standard time-to-event approaches and intention-to-treat principles. KEY FINDINGS AND LIMITATIONS: Between 2007 and 2015, 492 participants were randomised one of three groups: 166 None, 164 Short, and 162 Long. The median age at randomisation was 66 yr; Gleason scores at surgery were as follows:
Document Type: article in journal/newspaper
File Description: application/pdf
Language: English
Relation: https://discovery.ucl.ac.uk/id/eprint/10197099/1/RADICALS%20HD%203%20way%20comparison%20Parker%20et%20all%20Eur%20Urol%20%282024%29.pdf; https://discovery.ucl.ac.uk/id/eprint/10197099/
Availability: https://discovery.ucl.ac.uk/id/eprint/10197099/1/RADICALS%20HD%203%20way%20comparison%20Parker%20et%20all%20Eur%20Urol%20%282024%29.pdf; https://discovery.ucl.ac.uk/id/eprint/10197099/
Rights: open
Accession Number: edsbas.AD583D2B
Database: BASE