Evidence map›Paper›PMID 27626365›Full record

Trial reportThe New England journal of medicine2016

Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer.

J L Donovan, F C Hamdy, J A Lane, M Mason, C Metcalfe, E Walsh, J M Blazeby, T J Peters, P Holding, S Bonnington and 29 more

Erratum issued 7 registry-linked trialsOpen access · bronzeAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2016. 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 7 registered trials, which are not on this map. Cited by 590 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
590citing papers in PubMed, 8 pooled it
126.1field-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.

NCT02044172 naactive not recruitingnot on this map

The ProtecT Trial - Evaluating the Effectiveness of Treatments for Clinically Localised Prostate Cancer

TypeinterventionalSponsorUniversity of OxfordRan2001 to 2027Enrolled82,849ConditionsProstate CancerArmsRadical prostatectomy, Conformal radiation therapy, Active monitoring
NCT03814252 naactive not recruitingnot on this mapstarted 2018, after this paper: background citation

Prospective Clinical Safety and Efficacy Study of Lesion-targeted MRI-guided Transurethral Ultrasound Ablation for Localized Prostate Cancer

TypeinterventionalSponsorTurku University HospitalRan2018 to 2028Enrolled62ConditionsLocalized Prostate CancerArmsMRI-TULSA
NCT05936736 narecruitingnot on this mapstarted 2023, after this paper: background citation

24 Gy in One Fraction Urethral-sparing "High-Dose-Rate Like" Stereotactic Body RadioTherapy for Prostate Cancer: a Single-center Non-randomized Prospective Clinical Study (PRO-FAST)

TypeinterventionalSponsorIRCCS San RaffaeleRan2023 to 2030Enrolled70ConditionsLocalized Prostate CarcinomaArmsprostate SBRT
NCT06546267 recruitingnot on this mapstarted 2022, after this paper: background citation

Efficacy of Advanced Radiotherapy (ART) in Prostate Cancer Patients With Early Stage, Advanced, Metastatic and Relapsed Disease (PROST-ART)

TypeobservationalSponsorIRCCS San RaffaeleRan2022 to 2027Enrolled2,500ConditionsProstate CancerArmsImage Guided Radiotherapy, Intensity Modulated Radiotherapy, Stereotactic Body Radiotherapy
NCT06717711 phase3recruitingnot on this mapstarted 2023, after this paper: background citation

Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Robot-assisted Surgical Treatment of Genitourinary Cancers

TypeinterventionalSponsorRegina Elena Cancer InstituteRan2023 to 2028Enrolled158ConditionsProstate Carcinoma, Erectile Function, Genito Urinary CancerArmsLow-intensity Extracorporeal Shock Wave Therapy (LiESWT), PDE5 inhibitor (tadalafil)
NCT06916013 not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Transperineal Targeted Focal Laser Ablation of Localized Intermediate Risk Prostatic Adenocarcinoma (Pilot Study)

TypeobservationalSponsorAin Shams UniversityRan2025 to 2027Enrolled30ConditionsProstate Cancer, LaserArmsFocal laser ablation
NCT06966778 narecruitingnot on this mapstarted 2025, after this paper: background citation

A Double Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy of Oxybutynin Chloride Extended-Release Tablets to Improve Early Continence Recovery After Robotic Prostatectomy

TypeinterventionalSponsorNational Taiwan University HospitalRan2025 to 2028Enrolled135ConditionsLocalized Prostate Cancer, Postoperative Urinary IncontinenceArmsOxybutynin chloride extended-release tablets 5mg/tab, 2 tab, PO, qd., Placebo (2 tab), PO, qd.
3 · Its place in the literature

Who cites it

590 citing papers in PubMed, 8 syntheses or guidelines pooled it, 1,311 citations in OpenAlex.

  1. Pooled it
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530 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

39 authors at 13 institutions in 1 country.

J L Donovan *
F C Hamdy *
J A Lane *
M Mason
C Metcalfe
E Walsh
J M Blazeby
T J Peters
P Holding
S Bonnington
T Lennon
L Bradshaw
D Cooper
P Herbert
J Howson
A Jones
N Lyons
E Salter
P Thompson
S Tidball
J Blaikie
C Gray
P Bollina
J Catto
A Doble
A Doherty
D Gillatt
R Kockelbergh
H Kynaston
A Paul
P Powell
S Prescott
D J Rosario
E Rowe
M Davis
E L Turner
R M Martin
D E Neal *
ProtecT Study Group*
Leeds Teaching Hospitals NHS Trust · GBNorth Bristol NHS Trust · GBCardiff and Vale University Health Board · GBUniversity of Sheffield · GBWestern General Hospital · GBAddenbrooke's Hospital · GBFreeman Hospital · GBQueen Elizabeth Hospital Birmingham · GBUniversity Hospitals of Leicester NHS Trust · GBUniversity of Oxford · GBCardiff University · GBUniversity Hospitals Bristol NHS Foundation Trust · GBUniversity of Cambridge · GB

Funding

Cancer Research UK 15064
6 · The paper itself

Abstract

backgroundRobust data on patient-reported outcome measures comparing treatments for clinically localized prostate cancer are lacking. We investigated the effects of active monitoring, radical prostatectomy, and radical radiotherapy with hormones on patient-reported outcomes.

methodsWe compared patient-reported outcomes among 1643 men in the Prostate Testing for Cancer and Treatment (ProtecT) trial who completed questionnaires before diagnosis, at 6 and 12 months after randomization, and annually thereafter. Patients completed validated measures that assessed urinary, bowel, and sexual function and specific effects on quality of life, anxiety and depression, and general health. Cancer-related quality of life was assessed at 5 years. Complete 6-year data were analyzed according to the intention-to-treat principle.

resultsThe rate of questionnaire completion during follow-up was higher than 85% for most measures. Of the three treatments, prostatectomy had the greatest negative effect on sexual function and urinary continence, and although there was some recovery, these outcomes remained worse in the prostatectomy group than in the other groups throughout the trial. The negative effect of radiotherapy on sexual function was greatest at 6 months, but sexual function then recovered somewhat and was stable thereafter; radiotherapy had little effect on urinary continence. Sexual and urinary function declined gradually in the active-monitoring group. Bowel function was worse in the radiotherapy group at 6 months than in the other groups but then recovered somewhat, except for the increasing frequency of bloody stools; bowel function was unchanged in the other groups. Urinary voiding and nocturia were worse in the radiotherapy group at 6 months but then mostly recovered and were similar to the other groups after 12 months. Effects on quality of life mirrored the reported changes in function. No significant differences were observed among the groups in measures of anxiety, depression, or general health-related or cancer-related quality of life.

conclusionsIn this analysis of patient-reported outcomes after treatment for localized prostate cancer, patterns of severity, recovery, and decline in urinary, bowel, and sexual function and associated quality of life differed among the three groups. (Funded by the U.K. National Institute for Health Research Health Technology Assessment Program; ProtecT Current Controlled Trials number, ISRCTN20141297 ; ClinicalTrials.gov number, NCT02044172 .).

Indexed as

Health StatusProstatectomyQuality of LifeWatchful WaitingAgedDigestive System DiseasesErectile DysfunctionHumansIntention to Treat AnalysisMaleMiddle AgedOutcome Assessment, Health CareProstatic NeoplasmsSurveys and QuestionnairesTreatment OutcomeUrologic Diseases

Identifiers

PMID27626365
PMCPMC5134995
OpenAlexW2519027667

What OpenQuestion holds

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Registered trials

and 1 more above

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.