Evidence map›Paper›PMID 22808955›Full record

Trial reportThe New England journal of medicine2012

Radical prostatectomy versus observation for localized prostate cancer.

Timothy J Wilt, Michael K Brawer, Karen M Jones, Michael J Barry, William J Aronson, Steven Fox, Jeffrey R Gingrich, John T Wei, Patricia Gilhooly, B Mayer Grob and 12 more

Erratum issued 4 registry-linked trialsAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The New England journal of medicine, 2012. 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 4 registered trials, which are not on this map. Cited by 670 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
670citing papers in PubMed, 7 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.

NCT00007644 phase3completednot on this map

CSP #407 - Prostate Cancer Intervention Versus Observation Trial (PIVOT): A Randomized Trial Comparing Radical Prostatectomy Versus Palliative Expectant Management for the Treatment of Clinically Localized Prostate Cancer

TypeinterventionalSponsorVA Office of Research and DevelopmentRan1994 to 2010Enrolled731ConditionsProstate CancerArmsRadical prostatectomy
NCT01802307 phase2withdrawnnot on this mapstarted 2013, after this paper: background citation

Focal Therapy for the Treatment of Organ Confined Prostate Cancer

TypeinterventionalSponsorUniversity of Maryland, BaltimoreRan2013 to 2018Enrolled0ConditionsProstatic Neoplasms, Prostate CancerArmsBrachytherapy
NCT03255135 naunknown statusnot on this mapstarted 2018, after this paper: background citation

Initial Experience in Brazilian Single Center With High Intensity Focalized Ultrasound (HIFU) Prostate Cancer Therapy: Morbidity, Oncological and Functional Outcomes.

TypeinterventionalSponsorHospital de Transplante Doutor Euryclides de Jesus ZerbiniRan2018 to 2019Enrolled130ConditionsProstate Cancer, Prostate Adenocarcinoma, Transrectal High Intensity Focused UltrasoundArmsHIFU
NCT06589869 narecruitingnot on this mapstarted 2022, after this paper: background citation

To Investigate the Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of Stress Urinary Incontinence Compared With Standard of Care in Chinese Men Who Had Undergone Robotic Radical Prostatectomy

TypeinterventionalSponsorChinese University of Hong KongRan2022 to 2026Enrolled184ConditionsUrinary Incontinence , Stress, ProstatectomyArmsEM Chair, Standard of care
3 · Its place in the literature

Who cites it

670 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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  15. Head to head randomized trial of two decision aids for prostate cancer.BMC medical informatics and decision making · 2021
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610 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors.

Timothy J WiltCenter for Chronic Disease Outcomes Research, Minneapolis Veterans Affairs (VA) Health Care System, and Section of General Medicine, University of Minnesota School of Medicine, Minneapolis, USA. tim.wilt@va.gov
Michael K Brawer
Karen M Jones
Michael J Barry
William J Aronson
Steven Fox
Jeffrey R Gingrich
John T Wei
Patricia Gilhooly
B Mayer Grob
Imad Nsouli
Padmini Iyer
Ruben Cartagena
Glenn Snider
Claus Roehrborn
Roohollah Sharifi
William Blank
Parikshit Pandya
Gerald L Andriole
Daniel Culkin
Thomas Wheeler
Prostate Cancer Intervention versus Observation Trial (PIVOT) Study Group

Funding

UCLA SPORE IN PROSTATE CANCERP50CA092131 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI REITER, ROBERT E · 2002 to 2023
$42.6M
NCI NIH HHS P50 CA092131
6 · The paper itself

Abstract

backgroundThe effectiveness of surgery versus observation for men with localized prostate cancer detected by means of prostate-specific antigen (PSA) testing is not known.

methodsFrom November 1994 through January 2002, we randomly assigned 731 men with localized prostate cancer (mean age, 67 years; median PSA value, 7.8 ng per milliliter) to radical prostatectomy or observation and followed them through January 2010. The primary outcome was all-cause mortality; the secondary outcome was prostate-cancer mortality.

resultsDuring the median follow-up of 10.0 years, 171 of 364 men (47.0%) assigned to radical prostatectomy died, as compared with 183 of 367 (49.9%) assigned to observation (hazard ratio, 0.88; 95% confidence interval [CI], 0.71 to 1.08; P=0.22; absolute risk reduction, 2.9 percentage points). Among men assigned to radical prostatectomy, 21 (5.8%) died from prostate cancer or treatment, as compared with 31 men (8.4%) assigned to observation (hazard ratio, 0.63; 95% CI, 0.36 to 1.09; P=0.09; absolute risk reduction, 2.6 percentage points). The effect of treatment on all-cause and prostate-cancer mortality did not differ according to age, race, coexisting conditions, self-reported performance status, or histologic features of the tumor. Radical prostatectomy was associated with reduced all-cause mortality among men with a PSA value greater than 10 ng per milliliter (P=0.04 for interaction) and possibly among those with intermediate-risk or high-risk tumors (P=0.07 for interaction). Adverse events within 30 days after surgery occurred in 21.4% of men, including one death.

conclusionsAmong men with localized prostate cancer detected during the early era of PSA testing, radical prostatectomy did not significantly reduce all-cause or prostate-cancer mortality, as compared with observation, through at least 12 years of follow-up. Absolute differences were less than 3 percentage points. (Funded by the Department of Veterans Affairs Cooperative Studies Program and others; PIVOT ClinicalTrials.gov number, NCT00007644.).

Indexed as

ProstatectomyWatchful WaitingAgedFollow-Up StudiesHumansKaplan-Meier EstimateMaleMiddle AgedNumbers Needed To TreatPostoperative ComplicationsProstateProstate-Specific AntigenProstatic NeoplasmsProstate-Specific Antigen

Identifiers

PMID22808955
PMCPMC3429335

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.