Evidence map›Paper›PMID 39413377›Full record

Trial reportThe New England journal of medicine2024

Phase 3 Trial of Stereotactic Body Radiotherapy in Localized Prostate Cancer.

Nicholas van As, Clare Griffin, Alison Tree, Jaymini Patel, Peter Ostler, Hans van der Voet, Andrew Loblaw, William Chu, Daniel Ford, Shaun Tolan and 18 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIEquivalence TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 120 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
120citing papers in PubMed, 3 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.

NCT01584258 phase3active not recruitingnot on this map

International Randomised Study of Prostatectomy vs Stereotactic Body Radiotherapy (SBRT) and Conventionally Fractionated Radiotherapy vs SBRT for Organ-Confined Prostate Cancer

TypeinterventionalSponsorRoyal Marsden NHS Foundation TrustRan2012 to 2027Enrolled2,205ConditionsProstate CancerArmsProstatectomy, Conventionally Fractionated Prostate Radiotherapy, Prostate SBRT
NCT06772441 phase2recruitingnot on this map

Prostate-only, Dose-escalated Radiotherapy Plus Concomitant Androgen Deprivation Therapy in Primary Localized, NCCN High Risk and MMAI Classifier Low or Intermediate-risk Prostate Cancer - a Prospective, Single-arm, Phase II Study

TypeinterventionalSponsorGerman Oncology Center, CyprusRan2024 to 2027Enrolled30ConditionsProstate CancerArmsAndrogen deprivation therapy (ADT)
3 · Its place in the literature

Who cites it

120 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  13. Circadian Genotypes in PER3 and Time of Prostate Cancer Radiotherapy Interact to Affect Risk of Late Side Effects.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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  14. Review
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  20. Intermediate rectal dose is associated with late toxicity after prostate SBRT: a dose-volume histogram principal component analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Article

60 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

28 authors.

Nicholas van AsFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Clare GriffinFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Alison TreeFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Jaymini PatelFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Peter OstlerFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Hans van der VoetFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Andrew LoblawFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
William ChuFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Daniel FordFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Shaun TolanFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Suneil JainFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).ORCID 0000-0001-7429-4791
Philip CamilleriFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Kiran KancherlaFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
John FrewFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Andrew ChanFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Olivia NaismithFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
John ArmstrongFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
John StaffurthFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Alexander MartinFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Ian DayesFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Paula WellsFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Derek PriceFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Emily WilliamsonFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Julia PughFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Georgina ManningFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Stephanie BrownFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Stephanie BurnettFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).
Emma HallFrom the Royal Marsden Hospital (N.A., A.T., O.N.), the Institute of Cancer Research (N.A., C.G., A.T., J. Patel, E.W., J. Pugh, G.M., S. Brown, S. Burnett, E.H.), St. Bartholomew's Hospital (P.W.), and Patient and Public Representative (D.P.), London, the Mount Vernon Cancer Centre, Northwood (P.O.), the James Cook University Hospital, Middlesbrough (H.V.), University Hospitals Birmingham, Birmingham (D.F.), the Clatterbridge Cancer Centre, Birkenhead (S.T.), Queen's University Belfast, Belfast (S.J.), Churchill Hospital, Oxford (P.C.), University Hospitals of Leicester, Leicester (K.K.), Freeman Hospital, Newcastle (J.F.), University Hospitals Coventry and Warwickshire, Coventry (A.C.), Velindre Cancer Centre, Cardiff (J.S.), and Cambridge University Hospitals NHS Foundation Trust, Cambridge (A.M.) - all in the United Kingdom; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto (A.L., W.C.), and the Department of Oncology, McMaster University, Hamilton, ON (I.D.) - both in Canada; and Cancer Trials Ireland and St. Luke's Radiation Oncology Network, St. Luke's Hospital - both in Dublin (J.A.).

Funding

Cancer Research UK 15955Department of Health NIHR203314
6 · The paper itself

Abstract

backgroundWhether stereotactic body radiotherapy (SBRT) is noninferior to conventionally or moderately hypofractionated regimens with respect to biochemical or clinical failure in patients with localized prostate cancer is unclear.

methodsWe conducted a phase 3, international, open-label, randomized, controlled trial. Men with stage T1 or T2 prostate cancer, a Gleason score of 3+4 or less, and a prostate-specific antigen (PSA) level of no more than 20 ng per milliliter were randomly assigned (in a 1:1 ratio) to receive SBRT (36.25 Gy in 5 fractions over a period of 1 or 2 weeks) or control radiotherapy (78 Gy in 39 fractions over a period of 7.5 weeks or 62 Gy in 20 fractions over a period of 4 weeks). Androgen-deprivation therapy was not permitted. The primary end point was freedom from biochemical or clinical failure, with a critical hazard ratio for noninferiority of 1.45. The analysis was performed in the intention-to-treat population.

resultsA total of 874 patients underwent randomization at 38 centers (433 patients in the SBRT group and 441 in the control radiotherapy group) between August 2012 and January 2018. The median age of the patients was 69.8 years, and the median PSA level was 8.0 ng per milliliter; the National Comprehensive Cancer Network risk category was low for 8.4% of the patients and intermediate for 91.6%. At a median follow-up of 74.0 months, the 5-year incidence of freedom from biochemical or clinical failure was 95.8% (95% confidence interval [CI], 93.3 to 97.4) in the SBRT group and 94.6% (95% CI, 91.9 to 96.4) in the control radiotherapy group (unadjusted hazard ratio for biochemical or clinical failure, 0.73; 90% CI, 0.48 to 1.12; P = 0.004 for noninferiority), which indicated the noninferiority of SBRT. At 5 years, the cumulative incidence of late Radiation Therapy Oncology Group (RTOG) grade 2 or higher genitourinary toxic effects was 26.9% (95% CI, 22.8 to 31.5) with SBRT and 18.3% (95% CI, 14.8 to 22.5) with control radiotherapy (P<0.001), and the cumulative incidence of late RTOG grade 2 or higher gastrointestinal toxic effects was 10.7% (95% CI, 8.1 to 14.2) and 10.2% (95% CI, 7.7 to 13.5), respectively (P = 0.94).

conclusionsFive-fraction SBRT was noninferior to control radiotherapy with respect to biochemical or clinical failure and may be an efficacious treatment option for patients with low-to-intermediate-risk localized prostate cancer as defined in this trial. (Funded by Accuray and others; PACE-B ClinicalTrials.gov number, NCT01584258.).

Indexed as

Prostate-Specific AntigenProstatic NeoplasmsRadiation InjuriesRadiosurgeryAgedDose Fractionation, RadiationHumansIncidenceIntention to Treat AnalysisKaplan-Meier EstimateMaleNeoplasm GradingNeoplasm StagingTreatment FailureProstate-Specific Antigen

Identifiers

PMID39413377
PMCPMC7616714

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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.