Evidence map›Paper›PMID 38583574›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2024

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

C C Parker, P M Petersen, A D Cook, N W Clarke, C Catton, W R Cross, H Kynaston, W R Parulekar, R A Persad, F Saad and 49 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00541047 (Radiation Therapy and Androgen Deprivation Therapy in Treating Patients Who Have Undergone Surgery for Prostate Cancer), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00541047 phase3completednot on this map

Radiation Therapy and Androgen Deprivation Therapy in Treating Patients Who Have Undergone Surgery for Prostate Cancer (RADICALS)

TypeinterventionalSponsorUniversity College, LondonRan2007 to 2022Enrolled4,236ConditionsGastrointestinal Complications, Prostate Cancer, Sexual Dysfunction, Urinary ComplicationsArmsbicalutamide, goserelin acetate, leuprolide acetate, adjuvant therapy, quality-of-life assessment
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  5. Review
  6. Article
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  9. Observational
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  11. Review
  12. Real world comparison of adjuvant vs. salvage radiation therapy on cancer-control outcomes after radical prostatectomy.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2026
    Article
  13. Review
  14. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

59 authors.

C C ParkerInstitute of Cancer Research, Royal Marsden NHS Foundation Trust, Sutton, UK. Electronic address: chris.parker@rmh.nhs.uk.
P M PetersenDepartment of Oncology, Copenhagen Prostate Cancer Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
A D CookMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London.
N W ClarkeDepartment of Urology, The Christie NHS Foundation Trust, Manchester; Manchester Cancer Research Centre, The University of Manchester, Manchester; Department of Urology, Salford Royal NHS Foundation Trust, Manchester, UK, Department of Urology, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester, UK.
C CattonDepartment of Radiation Oncology, Princess Margaret Cancer Centre, University Health Network, Toronto, Canada.
W R CrossDepartment of Urology, St James's University Hospital, Leeds.
H KynastonDivision of Cancer and Genetics, Cardiff University, Cardiff, UK.
W R ParulekarCanadian Cancer Trials Group, Queen's University, Kingston, Canada.
R A PersadDepartment of Urology, Bristol Urological Institute, Bristol, UK.
F SaadDepartment of Urology, Centre Hospitalier de l'Université de Montréal, Montreal, Canada.
L BowerGuy's and St Thomas' NHS Foundation Trust, London; Institute of Cancer Research, Royal Marsden NHS Foundation Trust, London, UK.
G C DurkanDepartment of Urology, University Hospital Galway, Galway, Ireland.
J LogueDepartment of Oncology, The Christie Hospital NHS FT, Wilmslow Road, Manchester.
C ManiatisMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London.
D NoorMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London.
H PayneThe Prostate Centre, London.
J AndersonSt James's Institute of Oncology, Leeds.
A K BahlBristol Haematology and Oncology Centre, University Hospitals Bristol & Weston NHS Trust, Bristol.
F BashirQueen's Centre for Oncology, Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust, Cottingham, UK.
D M BottomleySt James's Institute of Oncology, Leeds.
K BrassoDepartment of Urology, Copenhagen Prostate Cancer Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
L CapaldiWorcester Oncology Centre, Worcestershire Acute NHS Hospitals Trust, Worcester.
C ChungMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London.
P W CookeDepartment of Urology, The Royal Wolverhampton NHS Trust, Wolverhampton.
J F DonohueDepartment of Urology, Maidstone and Tunbridge Wells NHS Trust, Maidstone.
B EddyEast Kent University Hospitals Foundation Trust, Kent.
C M HeathDepartment of Clinical Oncology, University Hospital Southampton NHS Foundation Trust, Southampton.
A HendersonDepartment of Urology, Maidstone and Tunbridge Wells NHS Trust, Maidstone.
A HenryLeeds Institute of Medical Research, University of Leeds, Leeds.
R JaganathanDepartment of Urology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
H JakobsenDepartment of Urology, Herlev University Hospital, Herlev, Denmark.
N D JamesInstitute of Cancer Research, Royal Marsden NHS Foundation Trust, London, UK.
J JosephLeeds Teaching Hospitals; York and Scarborough Teaching Hospitals, York.
K LeesKent Oncology Centre, Maidstone and Tunbridge Wells NHS Trust, Maidstone.
J LesterSouth West Wales Cancer Centre, Singleton Hospital, Swansea, UK.
H LindbergDepartment of Oncology, Herlev University Hospital, Herlev, Denmark.
A MakarDepartment of Urology, Worcestershire Acute Hospitals Trust, Worcester.
S L MorrisGuy's and St Thomas' NHS Foundation Trust, London.
N OommenWrexham Maelor Hospital, Wrexham.
P OstlerDepartment of Urology, Hillingdon Hospitals NHS Foundation Trust, Hillingdon, London.
L OwenBradford Royal Infirmary, Bradford; Leeds Cancer Centre, Leeds.
P PatelDepartment of Urology, University College London Hospitals, London.
A PopeDepartment of Urology, Hillingdon Hospitals NHS Foundation Trust, Hillingdon, London.
R PopertGuy's and St Thomas' NHS Foundation Trust, London.
R RamanKent Oncology Centre, Kent & Canterbury Hospital, Canterbury.
V RamaniDepartment of Urology, The Christie NHS Foundation Trust, Manchester.
A RøderDepartment of Urology, Copenhagen Prostate Cancer Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen.
I SayersDeanesly Centre, New Cross Hospital, Wolverhampton.
M SimmsDepartment of Urology, Hull University Hospitals NHS Trust, Hull.
V SrinivasanGlan Clwyd Hospital, Betsi Cadwaladr University Health Board, Rhyl.
S SundaramDepartment of Urology, Mid Yorkshire Teaching Hospital, Wakefield.
K L TarverDepartment of Oncology, Queen's Hospital, Romford.
A TranDepartment of Oncology, The Christie Hospital NHS FT, Wilmslow Road, Manchester.
P WellsBarts Cancer Centre, St Bartholomews Hospital, London.
J WilsonRoyal Gwent Hospital, Newport.
A M ZarkarDepartment of Oncology, University Hospitals Birmingham, Birmingham, UK.
M K B ParmarMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London.
M R SydesMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London. Electronic address: mrcctu.radicals@ucl.ac.uk.
RADICALS investigators

Funding

Cancer Research UK 6381Medical Research Council MC_UU_00004/02Medical Research Council MC_UU_12023/28
6 · The paper itself

Abstract

backgroundThe 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

methodsRADICALS-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)<1 favours Adjuvant-RT.

resultsBetween October 2007 and December 2016, 1396 participants from UK, Denmark, Canada and Ireland were randomised: 699 Salvage-RT, 697 Adjuvant-RT. Allocated groups were balanced with a median age of 65 years. Ninety-three percent (649/697) Adjuvant-RT reported RT within 6 months after randomisation; 39% (270/699) Salvage-RT reported RT during follow-up. Median follow-up was 7.8 years. With 80 distant metastasis events, 10-year FFDM was 93% for Adjuvant-RT and 90% for Salvage-RT: HR=0.68 [95% confidence interval (CI) 0.43-1.07, P=0.095]. Of 109 deaths, 17 were due to prostate cancer. Overall survival was not improved (HR=0.980, 95% CI 0.667-1.440, P=0.917). Adjuvant-RT reported worse urinary and faecal incontinence 1 year after randomisation (P=0.001); faecal incontinence remained significant after 10 years (P=0.017).

conclusionLong-term results from RADICALS-RT confirm adjuvant RT after radical prostatectomy increases the risk of urinary and bowel morbidity, but does not meaningfully improve disease control. An observation policy with salvage RT for PSA failure should be the current standard after radical prostatectomy. TRIAL IDENTIFICATION: RADICALS, RADICALS-RT, ISRCTN40814031, NCT00541047.

Indexed as

ProstatectomyProstatic NeoplasmsSalvage TherapyAgedHumansMaleMiddle AgedNeoplasm GradingNeoplasm Recurrence, LocalProstate-Specific AntigenRadiotherapy, AdjuvantTime FactorsProstate-Specific Antigenclinical triallong-term follow-upobservationalprostate cancerradiotherapyrandomised controlled trial

Identifiers

PMID38583574
PMCPMC7617161

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.