Publications
621 results found
Connor MJ, Edison M, Bass EJ, et al., 2021, MRI FINDINGS IN DE NOVO SYNCHRONOUS METASTATIC PROSTATE CANCER AND IMPLICATIONS FOR CYTOREDUCTIVE SURGERY, Publisher: LIPPINCOTT WILLIAMS & WILKINS, Pages: E587-E587, ISSN: 0022-5347
Walters U, Connor MJ, Bass EJ, et al., 2021, SWITCHING FROM SEDATION TO LOCAL ANAESTHETIC TRANSPERINEAL PROSTATE BIOPSIES: A COST-BENEFIT ANALYSIS, Annual Meeting of the American-Urological-Association (AUA), Publisher: LIPPINCOTT WILLIAMS & WILKINS, Pages: E622-E622, ISSN: 0022-5347
Eldred-Evans D, Ahmed HU, 2021, Population-based prostate cancer screening with magnetic resonance imaging or ultrasonography-The IP1-PROSTAGRAM study-reply, JAMA Oncology, Pages: E1-E1, ISSN: 2374-2445
Fiorentino F, 2021, Feasibility of Comparative Health Research Outcome of Novel Surgery in prostate cancer (IP4-CHRONOS): statistical analysis plan for the randomised feasibility phase of the CHRONOS study., Trials, Vol: 22, Pages: 1-12, ISSN: 1745-6215
BackgroundRandomised controlled trials (RCTs) for surgical interventions have often proven difficult with calls for innovative approaches. The Imperial Prostate (IP4) Comparative Health Research Outcomes of Novel Surgery in prostate cancer (IP4-CHRONOS) study aims to deliver level 1 evidence on outcomes following focal therapy which involves treating just the tumour rather than whole-gland surgery or radiotherapy. Our aim is to test the feasibility of two parallel RCTs within an overarching strategy that fits with existing patient and physician equipoise and maximises the chances of success and potential benefit to patients and healthcare services.Methods and designIP4-CHRONOS is a randomised, unblinded multi-centre study, including two parallel randomised controlled trials targeting the same patient population: IP4-CHRONOS-A and IP4-CHRONOS-B.IP4-CHRONOS-A is a 1:1 RCT and the other is a multi-arm, multi-stage (MAMS) RCT starting with three arms and a 1:1:1 randomisation. The two linked RCTs are discussed with patients at the time of consent and the choice of A or B is dependent on physician and patient equipoise. The primary outcome is the feasibility of recruitment, acceptance of randomisation and compliance to allocated arm.ResultsThis paper describes the statistical analysis plan (SAP) for the feasibility study within IP4-CHRONOS given its innovative approach. Version 1.0 of the SAP has been reviewed by the Trial Steering Committee (TSC), Chief Investigator (CI), Senior Statistician and Trial Statistician and signed off. The study is ongoing and recruiting. Recruitment is scheduled to finish later in 2021. The SAP documents approved methods and analyses that will be conducted. Since this is written in advance of the analysis, we avoid bias arising from prior knowledge of the study data and findings.DiscussionOur feasibility analysis will demonstrate if IP4-CHRONOS is feasible in terms of recruitment, randomisation and compliance, and whether to continue both A
Norris JM, Simmons LAM, Kanthabalan A, et al., 2021, Which prostate cancers are undetected by multiparametric magnetic resonance imaging in men with previous prostate biopsy? an analysis from the PICTURE study, European Urology Open Science, Vol: 30, Pages: 16-24, ISSN: 2666-1691
BackgroundMultiparametric magnetic resonance imaging (mpMRI) has improved risk stratification for suspected prostate cancer in patients following prior biopsy. However, not all significant cancers are detected by mpMRI. The PICTURE study provides the ideal opportunity to investigate cancer undetected by mpMRI owing to the use of 5 mm transperineal template mapping (TTPM) biopsy.ObjectiveTo summarise attributes of cancers systematically undetected by mpMRI in patients with prior biopsy.Design, setting, and participantsPICTURE was a paired-cohort confirmatory study in which men requiring repeat biopsy underwent mpMRI followed by TTPM biopsy.Outcome measurements and statistical analysisAttributes were compared between cancers detected and undetected by mpMRI at the patient level. Four predefined histopathological thresholds were used as the target condition for TTPM biopsy. Application of prostate-specific antigen density (PSAD) was explored.Results and limitationsWhen nonsuspicious mpMRI was defined as Likert score 1–2, 2.9% of patients (3/103; 95% confidence interval [CI] 0.6–8.3%) with definition 1 disease (Gleason ≥ 4 + 3 of any length or maximum cancer core length [MCCL] ≥ 6 mm of any grade) had their cancer not detected by mpMRI. This proportion was 6.5% (11/168; 95% CI 3.3–11%) for definition 2 disease (Gleason ≥ 3 + 4 of any length or MCCL ≥ 4 mm of any grade), 4.8% (7/146; 95% CI 2.0–9.6%) for any amount of Gleason ≥ 3 + 4 cancer, and 9.3% (20/215; 95% CI 5.8–14%) for any cancer. Definition 1 cancers undetected by mpMRI had lower overall Gleason score (p = 0.02) and maximum Gleason score (p = 0.01) compared to cancers detected by mpMRI. Prostate cancers undetected by mpMRI had shorter MCCL than cancers detected by mpMRI for every cancer threshold: definition 1, 6 versus 8 mm (p = 0.02); definition 2, 5 versus 6 mm (p = 0.04); any Gleason ≥ 3 + 4, 5 versus 6 mm (p = 0.03); and any cancer, 3 versus 5 mm (p = 0.0009
Bass EJ, Klimowska-Nassar N, Sasikaran T, et al., 2021, PROState pathway embedded comparative trial: the IP3-PROSPECT study, Contemporary Clinical Trials, Vol: 107, ISSN: 1551-7144
IntroductionThe traditional double blind RCT is the ‘gold standard’ trial design. For a variety of reasons, these designs often fail to accrue enough participants to conclude. This is particularly challenging in localized prostate cancer. The cohort multiple randomised controlled trial (cmRCT) trial design may represent an alternative approach to delivering robust comparative data in prostate cancer.Patients and methodsIP3-PROSPECT is a cmRCT designed to test multiple prostate cancer interventions from eligible men in one cohort. Key to the design is two points of consent. First, at point of consent one, men referred for prostate cancer investigations are invited to join the cohort. They may then be randomly invited at a later date to consider an intervention at point of consent two. In the pilot phase we will test the acceptability and feasibility of developing the cohort.ResultsAcceptability and feasibility of the study will be measured by a combination of quantitative and qualitative methods. The primary outcome measure is the rate of consent to inclusion to the IP3-PROSPECT cohort. Secondary outcome measures include the completeness of data collection at sites and return rates of patient questionnaires. We will also interview patients and healthcare professionals to explore their thoughts on the implementation, practicality and efficiency of IP3-PROSPECT.ConclusionThe IP3-PROSPECT study will evaluate the cmRCT design in prostate cancer. Initially we will pilot the design, assessing for acceptability and feasibility. The cmRCT is an innovative design that offers potential for building a modern comparative evidence base for prostate cancer.
Schoots IG, Ahmed HU, Padhani AR, 2021, Can Diagnostic Magnetic Resonance Imaging for Suspected Clinically Significant Prostate Cancer Predict Unfavorable Long-term Outcome for Diagnosed Men for Pretreatment Counseling?, EUROPEAN UROLOGY ONCOLOGY, Vol: 4, Pages: 529-531
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- Citations: 1
Reddy DT, Peters M, Shah T, et al., 2021, Cancer control outcomes following focal therapy using HIFU in 1,829 men with non-metastatic prostate cancer treated over 15 years, Publisher: ELSEVIER, Pages: S1491-S1492, ISSN: 0302-2838
Brembilla G, Giganti F, Sidhu H, et al., 2021, Ultra-fast biparametric MRI for prostate cancer detection, Publisher: ELSEVIER, Pages: S1262-S1262, ISSN: 0302-2838
Shah TT, Kanthabalan A, Pavlou M, et al., 2021, MRI and targeted biopsies compared to transperineal mapping biopsies for targeted ablation in recurrent prostate cancer after radiotherapy: Primary outcomes of the FORECAST trial, Publisher: ELSEVIER, Pages: S1690-S1691, ISSN: 0302-2838
Morote RJ, Campistol TM, Celma A, et al., 2021, Retrospective evaluation of Proclarix as a companion to mpMRI for the detection of clinically significant prostate cancer, Publisher: ELSEVIER, Pages: S1425-S1425, ISSN: 0302-2838
Grey ADR, Scott R, Shah B, et al., 2021, The CADMUS trial: A paired cohort, blinded study comparing multiparametric ultrasound targeted biopsies with multiparametric MRI targeted biopsies in the detection of clinically significant prostate cancer, Publisher: ELSEVIER, Pages: S1301-S1302, ISSN: 0302-2838
Aydin A, Ahmed K, Abe T, et al., 2021, Simulation in urological training and Education (SIMULATE): A randomised controlled clinical and educational trial to determine the effect of simulation-based surgical training, Publisher: ELSEVIER, Pages: S1353-S1354, ISSN: 0302-2838
Reddy DT, Peters M, Shah T, et al., 2021, Focal ablative salvage therapy for radio-recurrent prostate cancer: 6 year oncological and safety outcomes, Publisher: ELSEVIER, Pages: S1693-S1694, ISSN: 0302-2838
Walters U, Connor MJ, Bass EJ, et al., 2021, Switching from sedation to local anaesthetic transperineal prostate biopsies: A cost-benefit analysis, Publisher: ELSEVIER, Pages: S1245-S1245, ISSN: 0302-2838
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- Citations: 1
Connor MJ, Genie MG, Gonzalez M, et al., 2021, Metastatic prostate cancer patients' Attitudes towards Treatment of the local Tumour and metastasis Evaluative Research (IP5-MATTER): A multicentre, discrete choice experiment trial-in-progress, Publisher: ELSEVIER, Pages: S1217-S1218, ISSN: 0302-2838
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- Citations: 1
Connor MJ, Van Son M, Eldred-Evans D, et al., 2021, Impact of non-targeted prostate sampling histology on the probability of receiving invasive local treatment in an mpMRI-targeted pathway - analysis of 1,719 men, Publisher: ELSEVIER, Pages: S1412-S1413, ISSN: 0302-2838
Norris JM, Simmons LAM, Kanthabalan A, et al., 2021, Which prostate cancers are undetected by multiparametric magnetic resonance imaging in men with previous prostate biopsy? An analysis from the PICTURE study, Publisher: ELSEVIER, Pages: S1265-S1266, ISSN: 0302-2838
Shah TT, Reddy D, Peters M, et al., 2021, Focal therapy compared to radical prostatectomy for non-metastatic prostate cancer: a propensity score-matched study, PROSTATE CANCER AND PROSTATIC DISEASES, Vol: 24, Pages: 567-574, ISSN: 1365-7852
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- Citations: 23
Raison N, Musollari G, Man K, et al., 2021, Patient-specific risk factors and post-operative complications have a significant impact on long term functional outcomes following minimally invasive, Publisher: ELSEVIER, Pages: S1629-S1630, ISSN: 0302-2838
Ahmed H, 2021, Can quantitative analysis of multi-parametric MRI independently predict failure of focal salvage HIFU therapy in men with radio-recurrent prostate cancer?, Urologic Oncology: seminars and original investigations, Vol: 39, Pages: 830.e1-830.e8, ISSN: 1078-1439
ObjectivesFocal salvage HIFU is a feasible therapeutic option in some men who have recurrence after primary radiotherapy for prostate cancer. We aimed to determine if multi-parametric quantitative parameters, in addition to clinical factors, might have a role in independently predicting focal salvage HIFU outcomes.MethodsA retrospective registry analysis included 150 consecutive men who underwent focal salvage HIFU (Sonablate500) (2006-2015); 89 had mpMRI available. Metastatic disease was excluded by nodal assessment on pelvic MRI, a radioisotope bone-scan and/or choline or FDG PET/CT scan. All men had mpMRI and either transperineal template prostate mapping biopsy or targeted and systematic TRUS-biopsy. mpMRI included T2‐weighted, diffusion‐weighted and dynamic contrast‐enhancement. Pre-HIFU quantitative mpMRI data was obtained using Horos DICOM Viewer v3.3.5 for general MRI parameters and IB DCE v2.0 plug-in. Progression-free survival (PFS) was defined by biochemical failure and/or positive localized or distant imaging results and/or positive biopsy and/or systemic therapy and/or metastases/prostate cancer‐specific death. Potential predictors of PFS were analyzed by univariable and multivariable Cox-regression.ResultsMedian age at focal salvage HIFU was 71 years (interquartile range [IQR] 65–74.5) and median PSA pre-focal salvage treatment was 5.8ng/ml (3.8-8). Median follow-up was 35 months (23-47) and median time to failure was 15 months (7.8–24.3). D-Amico low, intermediate and high-risk disease was present in 1% (1/89), 40% (36/89) and 43% (38/89) prior to focal salvage HIFU (16% missing data). 56% (50/89) failed by the composite outcome. A total of 22 factors were evaluated on univariable and 8 factors on multivariable analysis. The following quantitative parameters were included: Ktrans, Kep, Ve, Vp, IS, rTTP and TTP. On univariable analysis, PSA, prostate volume at time of radiotherapy failure and Ve (median) value were predictors for failure. V
Shah TT, Kanthabalan A, Pavlou M, et al., 2021, MRI and targeted biopsies compared to transperineal mapping biopsies for targeted ablation in recurrent prostate cancer after radiotherapy: Primary outcomes of the FORECAST trial., Virtual Annual Meeting of the American-Society-of-Clinical-Oncology (ASCO), Publisher: LIPPINCOTT WILLIAMS & WILKINS, ISSN: 0732-183X
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- Citations: 1
Mangar S, Mondal S, Edwards S, et al., 2021, Evaluating the prevalence and nature of sleep disturbances in prostate cancer patients receiving androgen deprivation therapy using a combination of actigraphy and sleep questionnaires., Virtual Annual Meeting of the American-Society-of-Clinical-Oncology (ASCO), Publisher: LIPPINCOTT WILLIAMS & WILKINS, ISSN: 0732-183X
Grey A, Scott R, Shah B, et al., 2021, The CADMUS trial: A paired cohort, blinded study comparing multiparametric ultrasound targeted biopsies with multiparametric MRI targeted biopsies in the detection of clinically significant prostate cancer., Virtual Annual Meeting of the American-Society-of-Clinical-Oncology (ASCO), Publisher: LIPPINCOTT WILLIAMS & WILKINS, ISSN: 0732-183X
Peters M, van Son M, Moerland M, et al., 2021, Updated results of focal salvage high-dose-rate brachytherapy for radiorecurrent prostate cancer, Publisher: ELSEVIER IRELAND LTD, Pages: S22-S23, ISSN: 0167-8140
Peters M, van Son M, Moerland M, et al., 2021, Subdomains of erectile and urinary function after ultrafocal HDR-brachytherapy for prostate cancer, Publisher: ELSEVIER IRELAND LTD, Pages: S192-S193, ISSN: 0167-8140
Connor M, Khoo V, Watson V, et al., 2021, Radical treatment without cure: decision-making in oligometastatic prostate cancer, European Urology, Vol: 79, Pages: 558-560, ISSN: 0302-2838
Khoo CC, Eldred-Evans D, Peters M, et al., 2021, A Comparison of Prostate Cancer Detection between Visual Estimation (Cognitive Registration) and Image Fusion (Software Registration) Targeted Transperineal Prostate Biopsy, JOURNAL OF UROLOGY, Vol: 205, Pages: 1075-1081, ISSN: 0022-5347
Pye H, Singh S, Norris JM, et al., 2021, Evaluation of PSA and PSA Density in a Multiparametric Magnetic Resonance Imaging-Directed Diagnostic Pathway for Suspected Prostate Cancer: The INNOVATE Trial, CANCERS, Vol: 13
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- Citations: 10
Orczyk C, Barratt D, Brew-Graves C, et al., 2021, Prostate Radiofrequency Focal Ablation (ProRAFT) Trial: A Prospective Development Study Evaluating a Bipolar Radiofrequency Device to Treat Prostate Cancer, JOURNAL OF UROLOGY, Vol: 205, Pages: 1090-1098, ISSN: 0022-5347
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- Citations: 10
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