Evidence map›Paper›PMID 31866092›Full record

Trial reportEuropean urology2020

Salvage Radiotherapy Versus Hormone Therapy for Prostate-specific Antigen Failure After Radical Prostatectomy: A Randomised, Multicentre, Open-label, Phase 3 Trial (JCOG0401)

Akira Yokomizo, Masashi Wakabayashi, Takefumi Satoh, Katsuyoshi Hashine, Takahiro Inoue, Kiyohide Fujimoto, Shin Egawa, Tomonori Habuchi, Kiyotaka Kawashima, Osamu Ishizuka and 9 more

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Publisher
In one paragraph

Trial report in European urology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05781217 (Short Versus Long-term Androgen Deprivation Therapy Combined With Salvage Radiotherapy in Prostate Cancer Patients With Biochemical Recurrence After Prostatectomy), which is not on this map. Cited by 14 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing 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.

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
3 · Its place in the literature

Who cites it

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

  1. Pooled it
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors.

Akira YokomizoDepartment of Urology, Harasanshin Hospital, Fukuoka, Japan.
Masashi WakabayashiJapan Clinical Oncology Group Data Centre/Operations Office, National Cancer Centre Hospital, Tokyo, Japan.
Takefumi SatohDepartment of Urology, Kitasato University School of Medicine, Kanagawa, Japan.
Katsuyoshi HashineDepartment of Urology, National Hospital Organization Shikoku Cancer Centre, Ehime, Japan.
Takahiro InoueDepartment of Urology, Kyoto University Hospital, Kyoto, Japan.
Kiyohide FujimotoDepartment of Urology, Nara Medical University, Nara, Japan.
Shin EgawaDepartment of Urology, Jikei University Hospital, Tokyo, Japan.
Tomonori HabuchiDepartment of Urology, Akita University Graduate School of Medicine, Akita, Japan.
Kiyotaka KawashimaDepartment of Urology, Tochigi Cancer Centre, Tochigi, Japan.
Osamu IshizukaDepartment of Urology, Shinshu University School of Medicine, Nagano, Japan.
Nobuo ShinoharaDepartment of Renal and Genitourinary Surgery, Hokkaido University Hospital, Hokkaido, Japan.
Mikio SugimotoDepartment of Urology, Faculty of Medicine, Kagawa University, Kagawa, Japan.
Yasushi YoshinoDepartment of Urology, Nagoya University School of Medicine, Nagoya, Japan.
Keiji NiheiDivision of Radiation Oncology, Tokyo Metropolitan Cancer and Infectious Diseases Centre, Komagome Hospital, Bunkyo City, Japan.
Haruhiko FukudaJapan Clinical Oncology Group Data Centre/Operations Office, National Cancer Centre Hospital, Tokyo, Japan.
Ken-Ichi TobisuTokyo Metropolitan Cancer and Infectious disease Centre, Komagome Hospital, Bunkyo City, Japan.
Yoshiyuki KakehiDepartment of Urology, Faculty of Medicine, Kagawa University, Kagawa, Japan.
Seiji NaitoDepartment of Urology, Harasanshin Hospital, Fukuoka, Japan. Electronic address: naito@harasanshin.or.jp.
JCOG0401 Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNo standard therapy has been established for localised prostate cancer patients with prostate-specific antigen (PSA) failure after radical prostatectomy (RP).

objectiveTo determine whether radiotherapy ± hormone therapy is superior to hormone therapy alone in such patients. DESIGN, SETTING, AND

participantsThis study is a multicentre, randomised, open-label, phase 3 trial. Patients with localised prostate cancer whose PSA concentrations had decreased to <0.1 ng/ml after RP, and then increased to 0.4-1.0 ng/ml, were randomised to the salvage hormone therapy (SHT) group (80 mg bicalutamide [BCL] followed by luteinising hormone-releasing hormone agonist in case of BCL failure) or the salvage radiation therapy (SRT) ± SHT group (64.8 Gy of SRT followed by the same regimen as in the SHT group in case of SRT failure). From May 2004 to May 2011, 210 patients (105 in each arm) were registered, with the median follow-up being 5.5 yr. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was time to treatment failure (TTF) of BCL. RESULTS AND LIMITATIONS: TTF of BCL was significantly longer in the SRT ± SHT group (8.6 yr) than in the SHT group (5.6 yr; hazard ratio 0.56, 90% confidence interval [0.40-0.77]; one-sided p =  0.001). Thirty-two of 102 patients (31%) in the SRT ± SHT group did not have SRT treatment failure. However, clinical relapse-free survival and overall survival did not differ between the arms. The most frequent grade 3-4 adverse event was erectile dysfunction (83 patients [80%] in the SHT group vs. 76 [74%] in the SRT ± SHT group). Limitations include the short follow-up periods and surrogate endpoint setting to allow definitive conclusions.

conclusionsInitial SRT prolongs TTF of BCL in patients with post-RP PSA failure, indicating that SRT ± SHT is more beneficial than SHT alone. PATIENT SUMMARY: Patients who have prostate-specific antigen failure after radical prostatectomy benefit from salvage radiation therapy prior to salvage hormone therapy.

Indexed as

AgedAnilidesAntineoplastic AgentsGonadotropin-Releasing HormoneHumansMaleNitrilesProstatectomyProstate-Specific AntigenProstatic NeoplasmsSalvage TherapyTosyl CompoundsTreatment FailureAnilidesAntineoplastic AgentsbicalutamideGonadotropin-Releasing HormoneNitrilesProstate-Specific AntigenTosyl CompoundsProstate-specific antigen failureRadical prostatectomySalvage therapy

Identifiers

PMID31866092

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.