ArticleContemporary clinical trials2013
A multi-centre prospective development study evaluating focal therapy using high intensity focused ultrasound for localised prostate cancer: The INDEX study.
Article in Contemporary clinical trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 3 of them syntheses that pooled it.
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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.
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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.
Who cites it
31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 79 citations in OpenAlex.
- Transperineal biopsy devices in people with suspected prostate cancer - a systematic review and economic evaluation.Health technology assessment (Winchester, England) · 2024Pooled it
- Primary cryotherapy for localised or locally advanced prostate cancer.The Cochrane database of systematic reviews · 2018Pooled it
- The role of focal therapy in the management of localised prostate cancer: a systematic review.European urology · 2014Pooled it
- On the degrees of freedom of gridded control points in learning-based medical image registration.Medical physics · 2026Article
- The role of the radiologist in the prostate cancer multidisciplinary conference.Abdominal radiology (New York) · 2024Review
- Shifting to transperineal prostate biopsy: A narrative review.Prostate international · 2024Review
- Evaluation of post-ablation mpMRI as a predictor of residual prostate cancer after focal high intensity focused ultrasound (HIFU) ablation.Urologic oncology · 2022Article
- Article
- Focal therapy for localized prostate cancer in the era of routine multi-parametric MRI.Prostate cancer and prostatic diseases · 2020Review
- Focal therapy, time to join the multi-disciplinary team discussion?Translational andrology and urology · 2020Review
- Targeting the cancer lesion, not the whole prostate.Translational andrology and urology · 2020Review
- Current techniques of prostate biopsy: an update from past to present.Translational andrology and urology · 2020Review
- Automatic segmentation of prostate MRI using convolutional neural networks: Investigating the impact of network architecture on the accuracy of volume measurement and MRI-ultrasound registration.Medical image analysis · 2019Article
- The prostate cancer focal therapy.Gland surgery · 2018Review
- Focal Ablation of Prostate Cancer.Reviews in urology · 2018Article
- Multimodal Imaging in Focal Therapy Planning and Assessment in Primary Prostate Cancer.Clinical and translational imaging · 2017Article
- An update on focal therapy for prostate cancer.Nature reviews. Urology · 2016Review
- Standardization of definitions in focal therapy of prostate cancer: report from a Delphi consensus project.World journal of urology · 2016Review
- The challenging landscape of medical device approval in localized prostate cancer.Nature reviews. Urology · 2016Review
- Evaluating the Role of mpMRI in Prostate Cancer Assessment.Expert review of medical devices · 2016Review
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Authors and funding
13 authors at 7 institutions in 1 country.
Funding
Abstract
introductionFocal therapy offers the possibility of cancer control, without the side effect profile of radical therapies. Early single centre prospective development studies using high intensity focused ultrasound (HIFU) have demonstrated encouraging genitourinary functional preservation and short-term cancer control. Large multi-centre trials are required to evaluate medium-term cancer control and reproduce functional recovery. We describe the study design of an investigator-led UK multi-centre, single arm trial using HIFU to deliver focal therapy for men with localised prostate cancer.
methodsOne-hundred and forty men with histologically proven localised low or intermediate risk prostate cancer (PSA < 15, Gleason ≤ 7, ≤ T2cN0M0) will undergo precise characterisation of the prostate using a combination of multi-parametric (mp)MRI and transperineal template prostate mapping (TPM) biopsies. Unilateral dominant tumours, the so-called index lesion, will be eligible for treatment provided the contra-lateral side is free of 'clinically significant' disease (as defined by Gleason ≥ 7 or maximum cancer core length ≥4 mm). Patients will receive focal therapy using HIFU (Sonablate 500®). Treatment effect will be assessed by targeted biopsies of the treated area and TPM biopsies at 36-months.
resultsPrimary outcome is the absence of clinically significant disease based on 36-month post-treatment TPM biopsies. Secondary outcomes address a) genitourinary function using validated patient questionnaires (IPSS, IPSS-QoL, IIEF-15, EPIC-Urinary, EPIC-Bowel, FACT-P, EQ-5D), b) the predictive validity of imaging, and c) risk factors for treatment failure.
conclusionsINDEX will be the first multi-centre, medium term follow-up trial to evaluate the outcomes of a tissue preserving strategy for men with localised prostate cancer using the TPM-ablate-TPM strategy.
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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.