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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.

Titel:	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.
Autor/in / Beteiligte Person:	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
Link:	Full Text Finder (Volltext)
Zeitschrift:	BJU international, Jg. 130 (2022-07-01), Heft 1, S. 43-53
Veröffentlichung:	Oxford, UK : Blackwell Science, c1999-, 2022
Medientyp:	academicJournal
ISSN:	1464-410X (electronic)
DOI:	10.1111/bju.15669
Schlagwort:	Feasibility Studies Humans Male Prospective Studies Prostatectomy methods Treatment Outcome Prostatic Neoplasms pathology Quality of Life
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Language: English [BJU Int] 2022 Jul; Vol. 130 (1), pp. 43-53. <i>Date of Electronic Publication: </i>2022 Jan 27. MeSH Terms: Prostatic Neoplasms* / pathology ; Quality of Life* ; Feasibility Studies ; Humans ; Male ; Prospective Studies ; Prostatectomy / methods ; Treatment Outcome References: Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin 2020; 70: 7-30. ; James ND, Spears MR, Clarke NW et al. Survival with newly diagnosed metastatic prostate cancer in the "docetaxel era": data from 917 patients in the control arm of the STAMPEDE trial (MRC PR08, CRUK/06/019). Eur Urol 2015; 67: 1028-38. ; James ND, Sydes MR, Clarke NW et al. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. Lancet 2016; 387: 1163-77. ; Tosoian JJ, Gorin MA, Ross AE, Pienta KJ, Tran PT, Schaeffer EM. Oligometastatic prostate cancer: definitions, clinical outcomes, and treatment considerations. Nat Rev Urol 2017; 14: 15-25. ; Pompe RS, Neumann T, Kühnke L et al. Validation of the updated eighth edition of AJCC for prostate cancer: removal of pT2 substages - does extent of tumor involvement matter? Urol Oncol 2020; 38: 637.e1-7. ; Stevens DJ, Sooriakumaran P. Oligometastatic prostate cancer. Curr Treat Options Oncol 2016; 17: 62. ; Psaila B, Lyden D. The metastatic niche: adapting the foreign soil. Nat Rev Cancer 2009; 9: 285-93. ; Comen E, Norton L, Massagué J. Clinical implications of cancer self-seeding. Nat Rev Clin Oncol 2011; 8: 369-77. ; Kim MY, Oskarsson T, Acharyya S et al. Tumor self-seeding by circulating cancer cells. Cell 2009; 139: 1315-26. ; Weckermann D, Polzer B, Ragg T et al. Perioperative activation of disseminated tumor cells in bone marrow of patients with prostate cancer. J Clin Oncol 2009; 27: 1549-56. ; Chaffer CL, Weinberg RA. A perspective on cancer cell metastasis. Science 2011; 331: 1559-64. ; Morgan TM, Lange PH, Porter MP et al. Disseminated tumor cells in prostate cancer patients after radical prostatectomy and without evidence of disease predicts biochemical recurrence. Clin Cancer Res 2009; 15: 677-83. ; Sooriakumaran P, Nyberg T, Akre O et al. Survival among men at high risk of disseminated prostate cancer receiving initial locally directed radical treatment or initial androgen deprivation therapy. Eur Urol 2017; 72: 345-51. ; Parker CC, James ND, Brawley CD et al. Radiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer (STAMPEDE): a randomised controlled phase 3 trial. Lancet 2018; 392: 2353-66. ; Sun X, Briel M, Busse JW et al. Credibility of claims of subgroup effects in randomised controlled trials: systematic review. BMJ 2012; 344: e1553. ; Boevé LM, Hulshof MC, Vis AN et al. Effect on survival of androgen deprivation therapy alone compared to androgen deprivation therapy combined with concurrent radiation therapy to the prostate in patients with primary bone metastatic prostate cancer in a prospective randomised clinical trial: data from the HORRAD trial. Eur Urol 2019; 75: 410-8. ; Sooriakumaran P, Nyberg T, Akre O et al. Comparative effectiveness of radical prostatectomy and radiotherapy in prostate cancer: observational study of mortality outcomes. BMJ 2014; 348: g1502. ; Ranasinghe W, Chapin BF, Kim IY, Sooriakumaran P, Lawrentschuk N. The cytoreductive prostatectomy in metastatic prostate cancer: what the individual trials are hoping to answer. BJU Int 2020; 125: 792-800. ; Sooriakumaran P, Karnes J, Stief C et al. A multi-institutional analysis of perioperative outcomes in 106 men who underwent radical prostatectomy for distant metastatic prostate cancer at presentation. Eur Urol 2016; 69: 788-94. ; Donovan J, Mills N, Smith M et al. Quality improvement report: improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: presenting unbiased information to patients can be difficult. BMJ 2002; 325: 766-70. ; Donovan JL, Rooshenas L, Jepson M et al. Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI). Trials 2016; 17: 283. ; Elliott D, Hamdy FC, Leslie TA et al. Overcoming difficulties with equipoise to enable recruitment to a randomised controlled trial of partial ablation vs radical prostatectomy for unilateral localised prostate cancer. BJU Int 2018; 122: 970-7. ; Rooshenas L, Scott LJ, Blazeby JM et al. The QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation. J Clin Epidemiol 2019; 106: 108-20. ; Mottet N, Bellmunt J, Bolla M et al. EAU-ESTRO-SIOG guidelines on prostate cancer. Part 1: screening, diagnosis, and local treatment with curative intent. Eur Urol 2017; 71: 618-29. ; Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004; 240: 205-13. ; Tewari A, Sooriakumaran P, Bloch DA, Seshadri-Kreaden U, Hebert AE, Wiklund P. Positive surgical margin and perioperative complication rates of primary surgical treatments for prostate cancer: a systematic review and meta-analysis comparing retropubic, laparoscopic, and robotic prostatectomy. Eur Urol 2012; 62: 1-15. ; Wilson C, Rooshenas L, Paramasivan S et al. Development of a framework to improve the process of recruitment to randomised controlled trials (RCTs): the SEAR (Screened, Eligible, Approached, Randomised) framework. Trials 2018; 19: 50. ; Rooshenas L, Paramasivan S, Jepson M, Donovan JL. Intensive triangulation of qualitative research and quantitative data to improve recruitment to randomized trials: the QuinteT approach. Qual Health Res 2019; 29: 672-9. ; Ost P, Reynders D, Decaestecker K et al. Surveillance or metastasis-directed therapy for oligometastatic prostate cancer recurrence: a prospective, randomized, multicenter phase II trial. J Clin Oncol 2018; 36: 446-53. Grant Information: 22748 United Kingdom CRUK_ Cancer Research UK; 25812 United Kingdom CRUK_ Cancer Research UK Contributed Indexing: Keywords: #PCSM; #ProstateCancer; #uroonc; oligo-metastatic; prostate cancer; radical prostatectomy; robot-assisted; surgery Entry Date(s): Date Created: 20211208 Date Completed: 20220701 Latest Revision: 20240210 Update Code: 20240210

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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.