Evidence map›Paper›PMID 32886212›Full record

Trial reportJournal of cancer research and clinical oncology2021

Results of a randomized trial of treatment modalities in patients with low or early-intermediate risk prostate cancer (PREFERE trial).

Thomas Wiegel, Peter Albers, Detlef Bartkowiak, Roswitha Bussar-Maatz, Martin Härter, Glen Kristiansen, Peter Martus, Stefan Wellek, Heinz Schmidberger, Klaus Grozinger and 4 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Journal of cancer research and clinical oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01717677 (Preference Based Randomized Trial for Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.3field-weighted citation impact, top 17% 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.

NCT01717677 naterminatednot on this map

Preference Based Randomized Trial for Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk

TypeinterventionalSponsorAssociation of Urologic Oncology (AUO)Ran2012 to 2018Enrolled457ConditionsProstate CancerArmsradical prostatectomy, percutaneous radiation therapy, permanent seed implantation, Active Surveillance
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Robotic stereotactic body radiotherapy for localized prostate cancer: final analysis of the German HYPOSTAT trial.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2023
    Article
  5. Article
  6. Article
  7. Comparison of EBRT and I-125 seed brachytherapy concerning outcome in intermediate-risk prostate cancer.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2021
    Article
  8. Article
  9. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 13 institutions in 1 country.

Thomas WiegelDepartment of Radiotherapy and Radiation Oncology, University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany. thomas.wiegel@uniklinik-ulm.de.ORCID http://orcid.org/0000-0003-1363-1410
Peter AlbersDepartment of Urology, University Hospital Düsseldorf, Düsseldorf, Germany.
Detlef BartkowiakDepartment of Radiotherapy and Radiation Oncology, University Hospital Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany.
Roswitha Bussar-MaatzPREFERE Project Management, German Cancer Society, Berlin, Germany.
Martin HärterDepartment of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Glen KristiansenInstitute of Pathology, University Hospital Bonn, Bonn, Germany.
Peter MartusDepartment of Clinical Epidemiology and Applied Biostatistics, University Hospital Tübingen, Tübingen, Germany.
Stefan WellekDepartment of Medical Biostatistics, Epidemiology and Informatics, University of Mainz, Mainz, Germany.
Heinz SchmidbergerDepartment of Radiotherapy and Radiation Oncology, University Hospital Mainz, Mainz, Germany.
Klaus GrozingerDepartment of Urology, Klinikum Leverkusen, Leverkusen, Germany.
Peter RennerCenter for Urology, Lübeck, Germany.
Fried SchneiderDepartment of Urology, Klinikum Lippe Detmold, Detmold, Germany.
Martin BurmesterDepartment of Urology, Vinzenzkrankenhaus, Hannover, Germany.
Michael StöckleDepartment of Urology, University Hospital Homburg/Saar, Homburg, Germany.
Johannes Gutenberg University Mainz · DEDüsseldorf University Hospital · DEGerman Cancer Society · DEKlinikum Leverkusen · DEKlinikum Lippe · DESaarland University · DEUniversität Hamburg · DEUniversität Ulm · DEUniversity Children's Hospital Tübingen · DEUniversity Hospital Bonn · DEUniversity Hospital Ulm · DEUniversity of Lübeck · DEVinzenzkrankenhaus Hannover · DE

Funding

Deutsche Krebshilfe trial number 2011-PCA-01
6 · The paper itself

Abstract

purposeThe optimal treatment for patients with low to early-intermediate risk prostate cancer (PCa) remains to be defined. The randomized PREFERE trial (DRKS00004405) aimed to assess noninferiority of active surveillance (AS), external-beam radiotherapy (EBRT), or brachytherapy by permanent seed implantation (PSI) vs. radical prostatectomy (RP) for these patients.

methodsPREFERE was planned to enroll 7600 patients. The primary endpoint was disease specific survival. Patients with PCa stage ≤ cT2a, cN0/X, M0, PSA ≤ 10 ng/ml and Gleason-Score ≤ 3 + 4 at reference pathology were eligible. Patients were allowed to exclude one or two of the four modalities, which yielded eleven combinations for randomization. Sixty-nine German study centers were engaged in PREFERE.

resultsOf 2251 patients prescreened between 2012 and 2016, 459 agreed to participate in PREFERE. Due to this poor accrual, the trial was stopped. In 345 patients reference pathology confirmed inclusion criteria. Sixty-nine men were assigned to RP, 53 to EBRT, 93 to PSI, and 130 to AS. Forty patients changed treatment shortly after randomization, 21 to AS. Forty-eight AS patients with follow-up received radical treatment. Median follow-up was 19 months. Five patients died, none due to PCa; 8 had biochemical progression after radical therapy. Treatment-related acute grade 3 toxicity was reported in 3 RP patients and 2 PSI patients.

conclusionsIn this prematurely closed trial, we observed an unexpected high rate of termination of AS and an increased toxicity related to PSI. Patients hesitated to be randomized in a multi-arm trial. The optimal treatment of low and early-intermediate risk PCa remains unclear.

Indexed as

AdolescentAdultAgedBrachytherapyCombined Modality TherapyDisease ProgressionFollow-Up StudiesHumansMaleMiddle AgedPrognosisProstatectomyProstatic NeoplasmsWatchful WaitingYoung AdultActive surveillanceExternal beam radiotherapyPermanent seed implantationProstate cancerProstatectomyRandomized clinical trial

Identifiers

PMID32886212
PMCPMC7810635
OpenAlexW3083081354

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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.