Urological Cancer Clinical Advisory Group Research Update by Claire Matthews
This research update provides insights into national recruitment to urological cancer studies, with a focus on the West of England open and in-setup urological cancer studies for 2021-2022. The update includes details on various ongoing studies, sites, sample sizes, open and closure dates, and planned recruitment information.
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SWAG Network Urological Cancer Clinical Advisory Group Research Update - Claire Matthews 18/11/2021
National Recruitment to Urological Cancer Studies Apr 2020 - Nov 2021 Apr 20 - Mar 21 recruitment during the pandemic Apr 2020 - Mar 2021 Apr 2021 - Nov 2022 Apr 21 - Nov 22 Recovery of recruitment to research Data cut 11/11/2021 Source: ODP All Portfolio
West of England Open Urological Cancer Studies 21/22 CPMS No. Short Name Sites Open date Planned Closure Sample Size England England Recruits 12628 The PACE Study UHBW, GHFT 01/08/2012 30/06/2022 1500 1,443 18067 UHBW, NBT 05/10/2015 31/01/2022 7351 Add-Aspirin 6,973 33372 UHBW 05/05/2017 01/12/2021 85 UK P3BEP Trial 50 34496 Renal Adjuvant MultiPle Arm Randomised Trial (RAMPART) GHFT 19/07/2018 30/11/2023 940 272 34511 GHFT, UHBW 02/01/2018 15/04/2022 1652 PIVOTALBoost 1,117 35571 The ACE Study UHBW 30/10/2018 31/03/2022 290 223 36706 Erdafitinib compared with Vinflunine or Docetaxel or Pembrolizumab UHBW 26/06/2018 29/05/2023 7 14 39870 IMreal GWH, RUH 11/03/2019 15/06/2023 71 217 40086 Phase 3 Study of Pembrolizumab plus Enzalutamide in mCRPC UHBW 12/09/2019 30/04/2024 7 26 41201 PROTEUS NBT 11/07/2019 12/09/2026 60 54 42696 Enza-D Study version 1.0 UHBW 14/10/2020 31/10/2020 15 6 43756 MITRE RUH, UHBW in set up 08/07/2020 31/01/2025 1296 49 46367 IP5-MATTER RUH 01/02/2021 31/03/2022 220 92 47257 GHFT (1/3) 22/07/2021 31/01/2022 12 Phase 3 Study of TAVT-45 in patients with metastatic prostate cancer 2 47497 EPIC Trial UHBW 23/08/2021 31/03/23 37 1
West of England In Setup Urological Cancer Studies 21/22 CPMS No. Short Name Sites Planned Opening Planned Closure Sample Size England Sample Size UK 49811 177Lu-PNT2002 PSMA in Metastatic Castrate Resistant Prostate Cancer (SPLASH) BHOC (Dr Challapalli) 13/11/2021 04/07/2022 25 25 49286 Volga BHOC (Dr Challapalli) 17/11/2021 16/09/2023 18 34 47211 MK6482-011- An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination with Lenvatinib (MK-7902) vs Cabozantinib for Second-line or Third-line Treatment in Participants with Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti-PD-1/L1 Therapy BHOC (Dr Challapalli) - unsure of status RUH - Dr Beresford 31/01/2022 11/08/2023 30 30 44121 Phase 3 study of Viralym-M in patients with virus associated HC BHOC, BRHC - no PIs listed 31/07/2021 01/09/2022 16 16
National In Setup Urological Cancer Studies 21/22 CPMS No. Short Name Title Phase Planned Opening Planned Closure Sample Size England 49990 A Phase I/II trial of TT-702 in patients with advanced solid tumours CURATE - A Cancer Research UK Phase I/II, dose escalation and expansion trial of TT- 702, a selective adenosine A2BR antagonist, given orally as a monotherapy agent and in combination, in patients with advanced solid tumours. I/II 30/09/21 29/09/25 119 48860 Prostate Imaging using MRI +/- contrast Enhancement (PRIME) A study assessing whether bi-parametric MRI is non-inferior to multi-parametric MRI in the diagnosis of clinically significant prostate cancer N/A 01/06/21 31/12/23 500 48599 PART PART: A randomised controlled trial of Partial prostate Ablation versus Radical Treatment in intermediate risk, unilateral clinically localised prostate cancer III 01/02/22 01/04/25 734 48059 POWER (Partial or Whole gland for Erections) Randomized trial for the evaluation of erectile dysfunction after whole or partial gland prostate brachytherapy N/A 01/05/21 01/05/24 50 46263 NANABIS CHRONIC PAIN FROM METASTATIC BONE CANCER FOR MANAGEMENT OF NanaBis Monotherapy for the Management of Opioid-Requiring Chronic Pain Due to Metastatic Bone Cancer: A Phase 3 Multi-Centre, Double-Blind, Randomised-Withdrawal Active and Placebo-Controlled Clinical Study. An Oro Buccal Administered Equimolar THC and CBD Formulation as III 20/02/22 01/02/24 - 45624 STAMINA - Work Package 4 & 5 Supported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy - the STAMINA programme Work Package 4: A cluster randomised controlled trial of the clinical and cost effectiveness of the STAMINA lifestyle intervention. Work Package 5: A process evaluation exploring implementation of the STAMINA lifestyle intervention N/A 01/12/21 31/10/23 697 44497 DURANCE A phase Ib/II study to assess the safety and activity of DURvalumab (MEDI4736) in combination with S-488210/S-488211 vAccine in Non-muscle invasive bladder CancEr I/II 31/12/21 31/07/27 46 40589 A Phase I trial of CCT361814 in advanced cancer A Cancer Research UK Phase I, first in human clinical trial of CCT361814, a heat shock factor 1 (HSF1) pathway inhibitor given orally in patients with advanced cancer. I 01/08/19 31/01/22 51
CRN High Level Objectives (HLOs) 21/22 Efficient Study Delivery metrics (study level): Proportion of new commercial contract studies achieving or surpassing their recruitment target during their planned recruitment period, at confirmed CRN sites (studies opened and closed within the year) [80%] Phase 3 Study of TAVT-45 in patients with metastatic prostate cancer. Currently RED rated at study level Proportion of commercial contract studies in the MR process achieving or surpassing their recruitment target during their planned recruitment period [80%] None in WE Proportion of non-commercial studies in the MR process achieving or surpassing their recruitment target during their planned recruitment period [70%] UK P3BEP Trial. Currently RED rated at study level
CRN High Level Objectives (HLOs) 21/22 Participant Experience: Number of NIHR CRN Portfolio study participants responding to the Participant Research Experience Survey (PRES) each year [1,155]. 928 surveys returned to date Aim for each trust is to return surveys from 5% of participants recruited. Overall figure is 3.9% (range across the trusts is 0.8% - 34.1%) Ensure study is identified on completed PRES forms
NIHR ODP Open data platform. Data on performance and restart across whole CRN, including all specialty areas NIHR Be Part of Research See which studies are open across the country National Cancer Research Institute Portfolio Maps View current national portfolio of open, closed and in set up cancer studies Find a Clinical Research Study (ODP) Search for a study to fit criteria. Good for horizon scanning, eligibility criteria
Research Delivery Manager claire.matthews@nihr.ac.uk Research Portfolio Facilitator iqra.hussain@nihr.ac.uk Sub-specialty Lead Amit.bahl@uhbw.nhs.uk
