Evidence map›Paper›PMID 31062122›Full record

ArticleWorld journal of urology2020

Magnetic resonance imaging-guided transurethral ultrasound ablation of prostate tissue in patients with localized prostate cancer: single-center evaluation of 6-month treatment safety and functional outcomes of intensified treatment parameters.

G Hatiboglu, V Popeneciu, D Bonekamp, M Burtnyk, R Staruch, S Pahernik, G Tosev, J P Radtke, J Motsch, H P Schlemmer and 2 more

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Article in World journal of urology, 2020. 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
2.1field-weighted citation impact, top 12% 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.

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, 16 citations in OpenAlex.

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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

12 authors at 3 institutions in 2 countries.

G HatibogluDepartment of Urology, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany. gencay.hatiboglu@med.uni-heidelberg.de.ORCID http://orcid.org/0000-0003-0913-8420
V PopeneciuDepartment of Urology, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
D BonekampGerman Cancer Research Center (DKFZ), Heidelberg, Germany.
M BurtnykProfound Medical Inc., Toronto, ON, Canada.
R StaruchProfound Medical Inc., Toronto, ON, Canada.
S PahernikDepartment of Urology, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
G TosevDepartment of Urology, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
J P RadtkeDepartment of Urology, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
J MotschDepartment of Anaesthesiology, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
H P SchlemmerGerman Cancer Research Center (DKFZ), Heidelberg, Germany.
M HohenfellnerDepartment of Urology, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
J N Nyarangi-DixDepartment of Urology, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.
Heidelberg University · DEGerman Cancer Research Center · DEProfound Medical (Canada) · CA

Funding

Profound Medical, Toronto, ON, Canada -
6 · The paper itself

Abstract

objectivesTo evaluate the effect of intensified treatment parameters on safety, functional outcomes, and PSA after MR-Guided Transurethral Ultrasound Ablation (TULSA) of prostatic tissue. PATIENTS AND

methodsBaseline and 6-month follow-up data were collected for a single-center cohort of the multicenter Phase I (n = 14/30 at 3 sites) and Pivotal (n = 15/115 at 13 sites) trials of TULSA in men with localized prostate cancer. The Pivotal study used intensified treatment parameters (increased temperature and spatial extent of ablation coverage). The reporting site recruited the most patients to both trials, minimizing the influence of physician experience on this comparison of adverse events, urinary symptoms, continence, and erectile function between subgroups of both studies.

resultsFor Phase I and TACT patients, median age was 71.0 and 67.0 years, prostate volume 41.0 and 44.5 ml, and PSA 6.7 and 6.7 ng/ml, respectively. All 14 Phase I patients had low-risk prostate cancer, whereas 7 of 15 TACT patients had intermediate-risk disease. Baseline IIEF, IPSS, quality of life, and pad use were similar between groups. Pad use at 1 month and quality of life at 3 months favored Phase I patients. At 6 months, there were no significant differences in functional outcomes or adverse events.

conclusionTULSA demonstrated acceptable clinical safety in Phase I trial. Intensified treatment parameters in the TACT Pivotal trial increased ablation coverage from 90 to 98% of the prostate without affecting 6-month adverse events or functional outcomes. Long-term follow-up and 12-month biopsies are needed to evaluate oncological safety.

Indexed as

AgedClinical Trials, Phase I as TopicEndosonographyFeasibility StudiesHumansMagnetic Resonance ImagingMaleMiddle AgedMulticenter Studies as TopicProstateProstatic NeoplasmsSurgery, Computer-AssistedTransurethral Resection of ProstateTreatment OutcomeUltrasonography, InterventionalMRI-guidedOutcomePhase IPivotalTULSA

Identifiers

PMID31062122
OpenAlexW2943937295

What OpenQuestion holds

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Registered trials

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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.