Evidence map›Paper›PMID 34778095›Full record

ArticleFrontiers in oncology2021

Single-Center Evaluation of Treatment Success Using Two Different Protocols for MRI-Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer.

Gencay Hatiboglu, Valentin Popeneciu, David Bonekamp, Mathieu Burtnyk, Robert Staruch, Florian Distler, Jan Philipp Radtke, Johann Motsch, Heinz Peter Schlemmer, Sascha Pahernik and 1 more

Open access · goldAbstract read
In one paragraph

Article in Frontiers in oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact, top 78% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
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

11 authors at 2 institutions in 2 countries.

Gencay HatibogluDepartment of Urology, University of Heidelberg, Heidelberg, Germany.
Valentin PopeneciuDepartment of Urology, University of Heidelberg, Heidelberg, Germany.
David BonekampGerman Cancer Research Center Deutsches Krebsforschungszentrum (DKFZ), Heidelberg, Germany.
Mathieu BurtnykProfound Medical Inc., Mississauga, ON, Canada.
Robert StaruchProfound Medical Inc., Mississauga, ON, Canada.
Florian DistlerDepartment of Urology, University of Heidelberg, Heidelberg, Germany.
Jan Philipp RadtkeDepartment of Urology, University of Heidelberg, Heidelberg, Germany.
Johann MotschDepartment of Anaesthesiology, University of Heidelberg, Heidelberg, Germany.
Heinz Peter SchlemmerGerman Cancer Research Center Deutsches Krebsforschungszentrum (DKFZ), Heidelberg, Germany.
Sascha PahernikDepartment of Urology, University of Heidelberg, Heidelberg, Germany.
Joanne Nyarangi-DixDepartment of Urology, University of Heidelberg, Heidelberg, Germany.
Heidelberg University · DEProfound Medical (Canada) · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo assess differences in 24-month oncologic and functional outcomes in men with low to intermediate-risk prostate cancer treated with MRI-guided transurethral ultrasound ablation (TULSA) using intentionally conservative versus intensified treatment parameters. PATIENTS AND

methodsPatients from a single center involved in two multicenter trials were included in this analysis. This included 14 of 30 patients with Gleason 3 + 3 from a Phase I study using intentionally conservative treatment parameters, and 15 of 115 patients with Gleason ≤ 3 + 4 from a pivotal study using intensified parameters. Follow-up data compared across these cohorts included 12-month biopsy and MRI for all patients, and 24-month PSA, micturition and quality of life (IIEF, IPSS, IPSS-QOL). The prognostic value of baseline parameters and PSA kinetics on 12-month histological recurrence was evaluated by logistic regression.

results12-month biopsy revealed clinically significant residual disease in 4 (29%) and 2 (14%) patients from the Phase I and pivotal studies, respectively. PSA nadir was 0.7 ng/ml for Phase I and 0.5 ng/ml for pivotal study patients. Patient age at diagnosis, use of MRI fusion/systematic prostate biopsy, number of obtained cores at initial biopsy, PSA course, and PSA nadir were identified as prognostic factors for treatment success. All but one patient from each cohort maintained erection firmness sufficient for penetration. No cases of pad use were reported at 24 months. There were no Grade 4 or higher adverse events, and no late toxicity related to the procedure.

conclusionTwo-year follow-up demonstrated the efficacy of TULSA for the treatment of localized prostate cancer, and the durability of PSA and functional outcomes. Intensifying treatment parameters in the pivotal trial had no impact on safety or functional outcomes through 24 months, while reducing the recurrence rate for clinically significant disease. Careful patient selection by MRI fusion/systematic prostate biopsy and adequate follow-up through routine 12-month biopsy are recommended.

Indexed as

outcomephase 1 clinical studiespivotalsuccessTULSA

Identifiers

PMID34778095
PMCPMC8579125
OpenAlexW3208322675

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.