Evidence map›Paper›PMID 28146658›Full record

Trial reportThe New England journal of medicine2017

Radiation with or without Antiandrogen Therapy in Recurrent Prostate Cancer.

William U Shipley, Wendy Seiferheld, Himanshu R Lukka, Pierre P Major, Niall M Heney, David J Grignon, Oliver Sartor, Maltibehn P Patel, Jean-Paul Bahary, Anthony L Zietman and 13 more

4 registry-linked trialsOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 296 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
296citing papers in PubMed, 12 pooled it
64.0field-weighted citation impact, top 1% of its field
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.

NCT00002874 phase3completednot on this map

A PHASE III TRIAL OF RADIATION THERAPY WITH OR WITHOUT CASODEX IN PATIENTS WITH PSA ELEVATION FOLLOWING RADICAL PROSTATECTOMY FOR pT3N0 CARCINOMA OF THE PROSTATE

TypeinterventionalSponsorRadiation Therapy Oncology GroupRan1998 to 2022Enrolled840ConditionsProstate CancerArmsbicalutamide, radiation therapy, placebo
NCT05232578 phase3not yet recruitingnot on this mapstarted 2022, after this paper: background citation

Early Salvage Therapy for Patients With Advanced Features for Biochemical Relapse After Radical Prostatectomy for Localized Prostate Carcinoma In Correlation With Supposed Molecular-genetic Parameters of Higher Aggressiveness

TypeinterventionalSponsorGeneral University Hospital, PragueRan2022 to 2032Enrolled380ConditionsProstate CancerArmsEarly salvage radiotherapy (eSRT), Delayed Salvage radiotherapy (dSRT)
NCT05781217 phase3recruitingnot on this mapstarted 2023, after this paper: background citation

Short Versus Long-term Androgen Deprivation Therapy Combined With Salvage Radiotherapy in Prostate Cancer Patients With Biochemical Recurrence After Prostatectomy: a Multicentre Phase III Randomised Controlled Trial

TypeinterventionalSponsorInstituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología RadioterápicRan2023 to 2032Enrolled534ConditionsProstate Cancer, Salvage Radiotherapy, Biochemical Recurrence, Androgen Deprivation TherapyArmstriptorelin, goserelin, leuprorelin
NCT07483658 narecruitingnot on this mapstarted 2026, after this paper: background citation

Non-Inferiority Study Comparing Hypofractionated Post-Operative Salvage Radiotherapy Regimens: 45/62.5 Gy in 25 Fractions vs. 43/52.5 Gy in 20 Fractions for Grade 2+ GU or GI Toxicity (HYP-OP-RT)

TypeinterventionalSponsorCHU de Quebec-Universite LavalRan2026 to 2036Enrolled434ConditionsReccurent/Metastatic Solid Tumor Disease, Prostate Cancer (Post Prostatectomy), Prostate Cancer, Prostatic NeoplasmsArmsStandard Fractionation Post-Operative Salvage Radiotherapy (25 fractions), Hypofractionated Post-Operative Salvage Radiotherapy (20 fractions), Androgen Deprivation Therapy (ADT)
3 · Its place in the literature

Who cites it

296 citing papers in PubMed, 12 syntheses or guidelines pooled it, 652 citations in OpenAlex.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 8 institutions in 2 countries.

William U ShipleyFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
Wendy SeiferheldFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
Himanshu R LukkaFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
Pierre P MajorFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
Niall M HeneyFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
David J GrignonFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
Oliver SartorFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
Maltibehn P PatelFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
Jean-Paul BaharyFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
Anthony L ZietmanFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
Thomas M PisanskyFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
Kenneth L ZeitzerFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
Colleen A F LawtonFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
Felix Y FengFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
Richard D LovettFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
Alexander G BaloghFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
Luis SouhamiFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
Seth A RosenthalFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
Kevin J KerlinFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
James J DignamFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
Stephanie L PughFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
Howard M SandlerFrom Massachusetts General Hospital and Harvard Medical School, Boston (W.U.S., N.M.H., A.L.Z.); NRG Oncology Statistics and Data Management Center (W.S., J.J.D., S.L.P.) and Einstein Medical Center (K.L.Z.), Philadelphia; Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON (H.R.L., P.P.M., M.P.P.), Hospital Notre-Dame du Centre Hospitalier de l'Université de Montréal (J.-P.B.) and McGill University Health Centre (L.S.), Montreal, and Tom Baker Cancer Centre, Calgary, AB (A.G.B.) - all in Canada; Indiana University, Indianapolis (D.J.G.); Tulane University, New Orleans (O.S.); Mayo Clinic, Rochester, MN (T.M.P.); Medical College of Wisconsin, Milwaukee (C.A.F.L.); University of Michigan, Ann Arbor (F.Y.F.); University of Vermont Medical Center, Burlington (R.D.L.); Radiation Oncology Center, Sacramento (S.A.R.), and Cedars-Sinai Medical Center, Los Angeles (H.M.S.) - both in California; Wayne Radiation Oncology, Goldsboro, NC (K.J.K.); and the University of Chicago, Chicago (J.J.D.).
NRG Oncology RTOG
Juravinski Hospital · CAIndiana University – Purdue University Indianapolis · USHarvard University · USNRG Oncology · USEinstein Medical Center Philadelphia · USHamilton Health Sciences · CAJuravinski Cancer Centre · CAMayo Clinic in Arizona · US

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
RTOG Foreign AccrualU10CA021661 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI CURRAN, WALTER J. · 1985 to 2013
$150.3M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Elaina Harper · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
UM LAPs- U10 GrantU10CA180801 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ZALUPSKI, MARK M · 2014 to 2018
$3.7M
NCI NIH HHS U10 CA021661NCI NIH HHS U10 CA180801NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS UG1 CA189867
6 · The paper itself

Abstract

backgroundSalvage radiation therapy is often necessary in men who have undergone radical prostatectomy and have evidence of prostate-cancer recurrence signaled by a persistently or recurrently elevated prostate-specific antigen (PSA) level. Whether antiandrogen therapy with radiation therapy will further improve cancer control and prolong overall survival is unknown.

methodsIn a double-blind, placebo-controlled trial conducted from 1998 through 2003, we assigned 760 eligible patients who had undergone prostatectomy with a lymphadenectomy and had disease, as assessed on pathological testing, with a tumor stage of T2 (confined to the prostate but with a positive surgical margin) or T3 (with histologic extension beyond the prostatic capsule), no nodal involvement, and a detectable PSA level of 0.2 to 4.0 ng per milliliter to undergo radiation therapy and receive either antiandrogen therapy (24 months of bicalutamide at a dose of 150 mg daily) or daily placebo tablets during and after radiation therapy. The primary end point was the rate of overall survival.

resultsThe median follow-up among the surviving patients was 13 years. The actuarial rate of overall survival at 12 years was 76.3% in the bicalutamide group, as compared with 71.3% in the placebo group (hazard ratio for death, 0.77; 95% confidence interval, 0.59 to 0.99; P=0.04). The 12-year incidence of death from prostate cancer, as assessed by means of central review, was 5.8% in the bicalutamide group, as compared with 13.4% in the placebo group (P<0.001). The cumulative incidence of metastatic prostate cancer at 12 years was 14.5% in the bicalutamide group, as compared with 23.0% in the placebo group (P=0.005). The incidence of late adverse events associated with radiation therapy was similar in the two groups. Gynecomastia was recorded in 69.7% of the patients in the bicalutamide group, as compared with 10.9% of those in the placebo group (P<0.001).

conclusionsThe addition of 24 months of antiandrogen therapy with daily bicalutamide to salvage radiation therapy resulted in significantly higher rates of long-term overall survival and lower incidences of metastatic prostate cancer and death from prostate cancer than radiation therapy plus placebo. (Funded by the National Cancer Institute and AstraZeneca; RTOG 9601 ClinicalTrials.gov number, NCT00002874 .).

Indexed as

AgedAged, 80 and overAndrogen AntagonistsAnilidesCombined Modality TherapyDouble-Blind MethodFollow-Up StudiesGynecomastiaHumansIncidenceKaplan-Meier EstimateMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalNeoplasm StagingAndrogen AntagonistsAnilidesbicalutamideNitrilesTosyl Compounds

Identifiers

PMID28146658
PMCPMC5444881
OpenAlexW2585109238

What OpenQuestion holds

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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.