Evidence map›Paper›PMID 35370021›Full record

Trial reportEuropean urology2022

Magnetic Resonance Imaging and Targeted Biopsies Compared to Transperineal Mapping Biopsies Before Focal Ablation in Localised and Metastatic Recurrent Prostate Cancer After Radiotherapy.

Taimur T Shah, Abi Kanthabalan, Marjorie Otieno, Menelaos Pavlou, Rumana Omar, Sola Adeleke, Francesco Giganti, Chris Brew-Graves, Norman R Williams, Jack Grierson and 22 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European urology, 2022. 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 trial NCT01883128 (An Evaluation of a Novel Imaging Based Complex Diagnostic and Therapeutic Pathway Intervention for Men Who Fail Radiotherapy for Prostate Cancer.), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 9% 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.

NCT01883128 phase2unknown statusnot on this map

An Evaluation of a Novel Imaging Based Complex Diagnostic and Therapeutic Pathway Intervention for Men Who Fail Radiotherapy for Prostate Cancer.

TypeinterventionalSponsorUniversity College London HospitalsRan2014 to 2019Enrolled177ConditionsProgression of Prostate CancerArmsWhole Body MRI, Focal Salvage Therapy, MRI Targeted biopsies
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Article
  6. Salvage Reirradiation for Locally Recurrent Prostate Cancer: Results From a Prospective Study With 7.2 Years of Follow-Up.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Article
  7. Article
  8. Article
  9. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

32 authors at 9 institutions in 2 countries.

Taimur T ShahImperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK; Division of Surgery and Interventional Sciences, University College London, London, UK. Electronic address: t.shah@imperial.ac.uk.
Abi KanthabalanDivision of Surgery and Interventional Sciences, University College London, London, UK.
Marjorie OtienoDivision of Surgery and Interventional Sciences, University College London, London, UK.
Menelaos PavlouDepartment of Statistical Science, University College London, London, UK.
Rumana OmarDepartment of Statistical Science, University College London, London, UK.
Sola AdelekeDivision of Medicine, Faculty of Medicine, University College London, London, UK; Department of Oncology, King's College London, London, UK; Department of Oncology, Maidstone and Tunbridge Wells Hospital, Maidstone, UK; School of Cancer & Pharmaceutical Sciences, King's College London, Queen Square, London WC1N 3BG, UK; High Dimensional Neurology, Department of Brain Repair and Rehabilitation, UCL Queen Square Institute of Neurology, University College London, London, UK.
Francesco GigantiDivision of Surgery and Interventional Sciences, University College London, London, UK; Department of Radiology, University College London Hospital NHS Foundation Trust, London, UK.
Chris Brew-GravesDivision of Medicine, Faculty of Medicine, University College London, London, UK.
Norman R WilliamsDivision of Surgery and Interventional Sciences, University College London, London, UK.
Jack GriersonDivision of Surgery and Interventional Sciences, University College London, London, UK.
Haroon MiahDivision of Surgery and Interventional Sciences, University College London, London, UK.
Amr EmaraDepartment of Urology, Basingstoke and North Hampshire Hospital, Hampshire Hospitals NHS Foundation Trust, Basingstoke, UK; Urology Department, Ain Shams University Hospitals, Cairo, Egypt.
Athar HaroonDepartment of Nuclear Medicine, St. Bartholomew's Hospital, Barts Health NHS Trust, London, UK; Institute of Nuclear Medicine, University College London Hospitals NHS Foundation Trust, London, UK.
Arash LatifoltojarDivision of Medicine, Faculty of Medicine, University College London, London, UK; Department of Radiology, Royal Marsden NHS Foundation Trust, London, UK.
Harbir SidhuDivision of Medicine, Faculty of Medicine, University College London, London, UK; Department of Radiology, University College London Hospital NHS Foundation Trust, London, UK.
Joey ClementeDivision of Surgery and Interventional Sciences, University College London, London, UK.
Alex FreemanDepartment of Histopathology, University College London Hospital NHS Foundation Trust, London, UK.
Clement OrczykDivision of Surgery and Interventional Sciences, University College London, London, UK; Department of Urology, University College London Hospital NHS Foundation Trust, London, UK.
Ashok NikapotaSussex Cancer Centre. Royal Sussex County Hospital, Brighton, UK.
Tim DudderidgeDepartment of Urology, University Hospital Southampton NHS Trust, Southampton, UK.
Richard G HindleyDepartment of Urology, Basingstoke and North Hampshire Hospital, Hampshire Hospitals NHS Foundation Trust, Basingstoke, UK.
Jaspal VirdiDepartment of Urology, The Princess Alexandra Hospital NHS Trust, Harlow, UK.
Manit AryaImperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.
Heather PayneDepartment of Oncology, University College London and University College London Hospital NHS Foundation Trust, London, UK.
Anita MitraDepartment of Oncology, University College London and University College London Hospital NHS Foundation Trust, London, UK.
Jamshed BomanjiInstitute of Nuclear Medicine, University College London Hospitals NHS Foundation Trust, London, UK.
Mathias WinklerImperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.
Gail HoranDepartment of Oncology, Queen Elizabeth Hospital, Kings Lynn, UK.
Caroline M MooreDivision of Surgery and Interventional Sciences, University College London, London, UK; Department of Urology, University College London Hospital NHS Foundation Trust, London, UK.
Mark EmbertonDivision of Surgery and Interventional Sciences, University College London, London, UK; Department of Urology, University College London Hospital NHS Foundation Trust, London, UK.
Shonit PunwaniDivision of Medicine, Faculty of Medicine, University College London, London, UK; Department of Radiology, University College London Hospital NHS Foundation Trust, London, UK.
Hashim U AhmedImperial Prostate, Division of Surgery, Department of Surgery and Cancer, Imperial College London, London, UK; Imperial Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK.
University College London · GBBasingstoke and North Hampshire Hospital · GBFaculty (United Kingdom) · GBCharing Cross Hospital · GBImperial College Healthcare NHS Trust · GBPrincess Alexandra Hospital NHS Trust · GBRoyal Sussex County Hospital · GBUniversity College London Hospitals NHS Foundation Trust · GBUniversity Hospital Southampton NHS Foundation Trust · GB

Funding

Focal HIFU Ablation of Prostate Cancer Using Advanced Ultrasound GuidanceR01CA135089 · NCI · RIVERSIDE RESEARCH INSTITUTE · PI FELEPPA, ERNEST JOSEPH, SANGHVI, NARENDRA T · 2010 to 2013
$2.1M
NCI NIH HHS R01 CA135089
6 · The paper itself

Abstract

backgroundRecurrent prostate cancer after radiotherapy occurs in one in five patients. The efficacy of prostate magnetic resonance imaging (MRI) in recurrent cancer has not been established. Furthermore, high-quality data on new minimally invasive salvage focal ablative treatments are needed.

objectiveTo evaluate the role of prostate MRI in detection of prostate cancer recurring after radiotherapy and the role of salvage focal ablation in treating recurrent disease. DESIGN, SETTING, AND

participantsThe FORECAST trial was both a paired-cohort diagnostic study evaluating prostate multiparametric MRI (mpMRI) and MRI-targeted biopsies in the detection of recurrent cancer and a cohort study evaluating focal ablation at six UK centres. A total of 181 patients were recruited, with 155 included in the MRI analysis and 93 in the focal ablation analysis.

interventionPatients underwent choline positron emission tomography/computed tomography and a bone scan, followed by prostate mpMRI and MRI-targeted and transperineal template-mapping (TTPM) biopsies. MRI was reported blind to other tests. Those eligible underwent subsequent focal ablation. An amendment in December 2014 permitted focal ablation in patients with metastases. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary outcomes were the sensitivity of MRI and MRI-targeted biopsies for cancer detection, and urinary incontinence after focal ablation. A key secondary outcome was progression-free survival (PFS). RESULTS AND LIMITATIONS: Staging whole-body imaging revealed localised cancer in 128 patients (71%), with involvement of pelvic nodes only in 13 (7%) and metastases in 38 (21%). The sensitivity of MRI-targeted biopsy was 92% (95% confidence interval [CI] 83-97%). The specificity and positive and negative predictive values were 75% (95% CI 45-92%), 94% (95% CI 86-98%), and 65% (95% CI 38-86%), respectively. Four cancer (6%) were missed by TTPM biopsy and six (8%) were missed by MRI-targeted biopsy. The overall MRI sensitivity for detection of any cancer was 94% (95% CI 88-98%). The specificity and positive and negative predictive values were 18% (95% CI 7-35%), 80% (95% CI 73-87%), and 46% (95% CI 19-75%), respectively. Among 93 patients undergoing focal ablation, urinary incontinence occurred in 15 (16%) and five (5%) had a grade ≥3 adverse event, with no rectal injuries. Median follow-up was 27 mo (interquartile range 18-36); overall PFS was 66% (interquartile range 54-75%) at 24 mo.

conclusionsPatients should undergo prostate MRI with both systematic and targeted biopsies to optimise cancer detection. Focal ablation for areas of intraprostatic recurrence preserves continence in the majority, with good early cancer control. PATIENT SUMMARY: We investigated the role of magnetic resonance imaging (MRI) scans of the prostate and MRI-targeted biopsies in outcomes after cancer-targeted high-intensity ultrasound or cryotherapy in patients with recurrent cancer after radiotherapy. Our findings show that these patients should undergo prostate MRI with both systematic and targeted biopsies and then ablative treatment focused on areas of recurrent cancer to preserve their quality of life. This trial is registered at ClinicalTrials.gov as NCT01883128.

Indexed as

Prostatic NeoplasmsUrinary IncontinenceBiopsyCohort StudiesHumansImage-Guided BiopsyMagnetic Resonance ImagingMaleNeoplasm Recurrence, LocalProspective StudiesProstateQuality of LifeCryotherapyFocal ablationFocal therapyHigh-intensity focused ultrasoundMagnetic resonance imagingMetastasesProstate cancerRadiorecurrentRadiotherapyRecurrence

Identifiers

PMID35370021
PMCPMC9156577
OpenAlexW4221072612

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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.