Evidence map›Paper›PMID 41401176›Full record

ArticlePloS one2025

Phase II trial protocol of focal prostate ablation combined with androgen deprivation therapy for prostate cancer treatment.

Jason Koehler, Daniel Lama, Megan Mendez, Wei-Wen Hsu, Aytekin Oto, Russell Szmulewitz, Abhinav Sidana

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05790213 (Phase II Trial of Focal Prostate Ablation Combined With Androgen Deprivation Therapy for Prostate Cancer Treatment), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 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.

NCT05790213 phase2recruitingnot on this map

Phase II Trial of Focal Prostate Ablation Combined With Androgen Deprivation Therapy for Prostate Cancer Treatment

TypeinterventionalSponsorUniversity of ChicagoRan2025 to 2028Enrolled57ConditionsProstate CancerArmsAndrogen Deprivation Therapy (ADT), Focal prostate ablation (focal therapy)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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

7 authors.

Jason KoehlerUniversity of Cincinnati College of Medicine, Cincinnati, Ohio, United States of America.ORCID https://orcid.org/0000-0003-4533-3813
Daniel LamaDepartment of Urology, University of Cincinnati, Cincinnati, Ohio, United States of America.
Megan MendezSection of Urology, Department of Surgery, University of Chicago, Chicago, Illinois, United States of America.
Wei-Wen HsuDivision of Biostatistics and Bioinformatics, University of Cincinnati College of Medicine, Cincinnati, Ohio, United States of America.ORCID https://orcid.org/0000-0002-7822-0826
Aytekin OtoDepartment of Radiology, University of Chicago, Chicago, Illinois, United States of America.
Russell SzmulewitzSection of Hematology/Oncology, Department of Internal Medicine, University of Chicago, Chicago, Illinois, United States of America.
Abhinav SidanaSection of Urology, Department of Surgery, University of Chicago, Chicago, Illinois, United States of America.ORCID https://orcid.org/0000-0002-3197-7215

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProstate cancer (PCa) is one of the most commonly diagnosed cancers. Treatments for PCa with less adverse effects than whole gland interventions, such as focal therapy (FT), often involve a higher risk of PCa recurrence. Combining FT with other treatments could increase the efficacy while maintaining a low side effect profile. This study aims to determine the proportion of residual/recurrent clinically significant PCa following the combination treatment of three months of androgen deprivation therapy (ADT) and FT of the prostate, as well as the safety of this treatment regimen.

methodsThis study will be a single arm phase II trial with a recruitment goal of 57 patients with treatment naïve non-metastatic intermediate risk PCa. Patients will complete the I-PSS, SHIM, and EPIC-26 questionnaires at the screening visit. Patients will then comply with a three-month treatment course of ADT. Eight weeks after beginning ADT, patients will undergo FT of the prostate via high intensity focused ultrasound or cryoablation. Follow up visits will occur every three months for a year post FT to monitor for side effects, repeat questionnaires, perform a clinical assessment, and obtain PSA and testosterone values. Twelve months after FT, a surveillance multiparametric MRI and MRI-targeted biopsy will be performed to assess for treatment failure. DISCUSSION: The primary endpoint of this trial is to determine the proportion of men with clinically significant PCa as evaluated by a surveillance mpMRI and MRI-TB at 12-months following FT. If successful, this treatment approach could offer a new option for treatment with fewer side effects than whole gland interventions and more efficacy than FT alone. Furthermore it could inform the need for further research into multimodal treatment options for PCa. CLINICAL

trial registrationClinicalTrials.gov, NCT05790213. Registered on March 30, 2023.

Indexed as

Androgen AntagonistsProstatic NeoplasmsAgedClinical Trials, Phase II as TopicCombined Modality TherapyHigh-Intensity Focused Ultrasound AblationHumansMaleMiddle AgedProstateAndrogen Antagonists

Identifiers

PMID41401176
PMCPMC12707638

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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.