Evidence map›Paper›PMID 40752653›Full record

Trial reportInternational journal of radiation oncology, biology, physics2025

Long-Term Results of NRG/RTOG 9601, a Randomized Trial of Radiation With or Without Antiandrogens in Patients Receiving Salvage Prostate Bed Radiation Therapy Postprostatectomy.

Himanshu R Lukka, Stephanie L Pugh, William U Shipley, Pierre P Major, Oliver Sartor, Ian S Dayes, Jean-Paul Bahary, Jason A Efstathiou, Thomas M Pisansky, Kenneth L Zeitzer and 10 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
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

20 authors.

Himanshu R LukkaDepartment of Oncology, McMaster University, Hamilton, Ontario, Canada. Electronic address: lukkahim@hhsc.ca.
Stephanie L PughNRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania; Statistics Department, American College of Radiology, Philadelphia Pennsylvania.
William U ShipleyDepartment of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
Pierre P MajorDepartment of Medical Oncology, Juravinski Cancer Centre, Hamilton, Ontario, Canada.
Oliver SartorDepartment of Radiation Oncology(tmp), Mayo Clinic, Rochester, Minnesota; Department of Medical Oncology(os), Mayo Clinic, Rochester, Minnesota.
Ian S DayesDepartment of Oncology, McMaster University, Hamilton, Ontario, Canada.
Jean-Paul BaharyDepartment of Radiation Oncology, Centre Hospitalier de l`Université de Montréal, Montreal, Quebec, Canada.
Jason A EfstathiouDepartment of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
Thomas M PisanskyDepartment of Radiation Oncology(tmp), Mayo Clinic, Rochester, Minnesota; Department of Medical Oncology(os), Mayo Clinic, Rochester, Minnesota.
Kenneth L ZeitzerDepartment of Radiation Oncology, Jefferson Einstein Hospital, Philadelphia, Pennsylvania.
Colleen A F LawtonDepartment of Radiation Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin.
Robert T DessDepartment of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.
Andrew S CamarataDartmouth Hitchcock Medical Center, Lebanon, New Hampshire; Department of Radiation Oncology, Naval Medical Center, Portsmouth, Virginia.
Alexander G BaloghDepartment of Radiation Oncology, Tom Baker Cancer Centre, Calgary, Alberta, Canada.
Luis SouhamiDepartment of Radiation Oncology, McGill University Health Centre, Montreal, Quebec, Canada.
Seth A RosenthalDepartment of Radiation Oncology, Sutter Cancer Centers/Sutter Medical Group, Sacramento/Roseville, California.
J Daniel PenningtonSoutheast Clinical Oncology Research Consortium NCORP, Winston Salem, North Carolina; Department of Radiation Oncology, Virginia Urology, Richmond, Virginia.
Wendy F SeiferheldNRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania; Statistics Department, American College of Radiology, Philadelphia Pennsylvania.
Felix Y FengDepartment of Radiation Oncology, University of California, San Francisco, California.
Howard M SandlerDepartment of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California.

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam, GREG YOTHERS · 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
NCI, National Clinical Trials Network Lead Academic Participating Site (LAPS) UG1 (funded extension)UG1CA232760 · NCI · MAYO CLINIC ROCHESTER · PI Judy Caroline Boughey, Aaron Scott Mansfield · 2019 to 2026
$8.5M
UM LAPs -UG1 GrantUG1CA233160 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ANNE F SCHOTT · 2019 to 2026
$5.4M
NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS UG1 CA189867NCI NIH HHS UG1 CA232760NCI NIH HHS UG1 CA233160
6 · The paper itself

Abstract

purposeSalvage radiation therapy (RT) is used in men with prostate cancer (PC) recurrence following radical prostatectomy signaled by a persistent or delayed elevation in prostate specific antigen. It was previously reported that the use of antiandrogen therapy (AAT) with RT improved cancer control and overall survival (OS). Long-term follow-up results are presented in this study. METHODS AND MATERIALS: From 1998 to 2003, 760 eligible postradical prostatectomy patients with stage pT3N0 or with pT2N0 and positive margins and prostate specific antigen from 0.2 to 4.0 ng/mL were randomly assigned on a double-blinded, placebo-controlled trial of RT + placebo versus RT + AAT (24 months of bicalutamide, 150 mg daily) during and after RT (64.8 Gy in 36 fractions prostate bed). The primary endpoint was OS estimated using Kaplan-Meier method. Time to PC death and metastatic PC (competing risk of death without an event) was estimated using cumulative incidence. The hazard ratio (HR) was obtained using Cox models (OS) and subdistribution HRs (sHRs) used the Fine-Gray model (time to PC death and metastatic PC).

resultsMedian follow-up for surviving patients was 18.9 years. OS at 18 years was 53% (95% CI, 47%-58%) for RT + AAT and 43% (95% CI, 38%-49%) for RT + placebo (adjusted HR = 0.82; 95% CI, 0.67-1.00; 1-sided P = .025). The 18-year incidence of centrally reviewed PC deaths was 18% (95% CI, 14%-22%) RT + AAT and 28% (95% CI, 23-33%) RT + placebo (unadjusted sHR = 0.63; 95% CI, 0.46-0.84; 2-sided P = .002). The 18-year incidence of metastatic PC was 22% (95% CI, 18-26%) and 31% (95% CI, 26-36%) for AAT and placebo arms, respectively (unadjusted sHR = 0.62; 95% CI, 0.46-0.83; 2-sided P = .001).

conclusionsLong-term results of 24-month duration AAT during and after salvage RT are consistent with the primary report with significantly improved long-term OS, reduced incidence of metastatic PC, and PC death for RT + AAT. In comparison with previous reports, the improvement in OS with AAT has risen from 5% at 12 years to 9.8% at 18 years.

Indexed as

Androgen AntagonistsAnilidesNeoplasm Recurrence, LocalNitrilesProstatic NeoplasmsSalvage TherapyTosyl CompoundsAgedCombined Modality TherapyDouble-Blind MethodFollow-Up StudiesHumansMaleMiddle AgedProstatectomyProstate-Specific AntigenAndrogen AntagonistsAnilidesbicalutamideNitrilesProstate-Specific AntigenTosyl Compounds

Identifiers

PMID40752653
PMCPMC12875213

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.