eprintid: 10163970 rev_number: 10 eprint_status: archive userid: 699 dir: disk0/10/16/39/70 datestamp: 2023-01-31 11:13:04 lastmod: 2024-10-21 15:27:49 status_changed: 2023-01-31 11:13:04 type: article metadata_visibility: show sword_depositor: 699 creators_name: Sooriakumaran, P creators_name: Wilson, C creators_name: Rombach, I creators_name: Hassanali, N creators_name: Aning, J creators_name: D. Lamb, A creators_name: Cathcart, P creators_name: Eden, C creators_name: Ahmad, I creators_name: Rajan, P creators_name: Sridhar, A creators_name: Bryant, RJ creators_name: Elhage, O creators_name: Cook, J creators_name: Leung, H creators_name: Soomro, N creators_name: Kelly, J creators_name: Nathan, S creators_name: Donovan, JL creators_name: Hamdy, FC title: Feasibility and safety of radical prostatectomy for oligo-metastatic prostate cancer: the Testing Radical prostatectomy in men with prostate cancer and oligo-Metastases to the bone (TRoMbone) trial ispublished: pub subjects: UCH divisions: UCL divisions: B02 divisions: C10 divisions: D16 divisions: G88 keywords: Science & Technology, Life Sciences & Biomedicine, Urology & Nephrology, prostate cancer, oligo-metastatic, radical prostatectomy, robot-assisted, surgery, #PCSM, #ProstateCancer, #uroonc, SURVIVAL note: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions. abstract: Objectives: To test the feasibility of randomisation to radical prostatectomy (RP) plus pelvic lymphadenectomy in addition to standard-of-care (SOC) systemic therapy in men with newly diagnosed oligo-metastatic prostate cancer. Patients and Methods: A prospective, randomised, non-blinded, feasibility clinical trial with an embedded QuinteT Recruitment Intervention (QRI) to optimise recruitment was conducted in nine nationwide tertiary care centres undertaking high-volume robotic surgery. We aimed to randomise 50 men with synchronous oligo-metastatic prostate cancer within an 18-month recruitment period to SOC systemic therapy vs SOC plus RP (intervention arm). The main outcome measures were: ability to randomise patients, optimised by a QRI; EuroQoL five Dimensions five Levels (EQ-5D-5L) questionnaires to capture quality-of-life (QoL) data at baseline and 3 months post-randomisation; routine clinicopathological assessment to capture adverse events and prostate-specific antigen in both arms, plus standard perioperative parameters in the surgical arm. Results: A total of 51 men were randomised within 14 months (one was subsequently deemed ineligible), with 60–83% accrual rate in centres that recruited at least two patients. All patients completed the trial follow-up; one patient in the intervention arm subsequently did not undergo the surgical intervention and one in the SOC arm refused all therapies. The QRI positively impacted recruitment. QoL data showed similarly high functioning in both study arms. Surgery for men with oligo-metastatic prostate cancer was found to be safe and had similar impact on early functional outcomes as surgery for standard indication. Conclusion: It is feasible to randomise men with synchronous oligo-metastatic prostate cancer to a surgical intervention in addition to standard systemic therapies. While surgery appeared safe with no substantial impact on QoL in this feasibility study, a large randomised controlled trial is now warranted to examine treatment effectiveness of this additional component in the multimodality management of oligo-metastatic prostate cancer. date: 2022-07-01 date_type: published publisher: WILEY official_url: https://doi.org/10.1111/bju.15669 oa_status: green full_text_type: other language: eng primo: open primo_central: open_green verified: verified_manual elements_id: 1910094 doi: 10.1111/bju.15669 medium: Print-Electronic lyricists_name: Kelly, John lyricists_name: Sridhar, Ashwin lyricists_name: Rajan, Prabhakar lyricists_id: JDKEL61 lyricists_id: ASRID01 lyricists_id: PRAJA07 actors_name: Flynn, Bernadette actors_id: BFFLY94 actors_role: owner funding_acknowledgements: [Prostate Cancer Foundation, USA]; [Urology Foundation, UK] full_text_status: public publication: BJU International volume: 130 number: 1 pagerange: 43-53 event_location: England issn: 1464-4096 citation: Sooriakumaran, P; Wilson, C; Rombach, I; Hassanali, N; Aning, J; D. Lamb, A; Cathcart, P; ... Hamdy, FC; + view all <#> Sooriakumaran, P; Wilson, C; Rombach, I; Hassanali, N; Aning, J; D. Lamb, A; Cathcart, P; Eden, C; Ahmad, I; Rajan, P; Sridhar, A; Bryant, RJ; Elhage, O; Cook, J; Leung, H; Soomro, N; Kelly, J; Nathan, S; Donovan, JL; Hamdy, FC; - view fewer <#> (2022) Feasibility and safety of radical prostatectomy for oligo-metastatic prostate cancer: the Testing Radical prostatectomy in men with prostate cancer and oligo-Metastases to the bone (TRoMbone) trial. BJU International , 130 (1) pp. 43-53. 10.1111/bju.15669 <https://doi.org/10.1111/bju.15669>. Green open access document_url: https://discovery.ucl.ac.uk/id/eprint/10163970/1/Kelly_extracted_Kelly_BJU_2021_1244.R1.pdf