PD15-09 TROMBONE: TESTING RADICAL PROSTATECTOMY IN MEN WITH OLIGOMETASTATIC PROSTATE CANCER THAT HAS SPREAD TO THE BONE- A RANDOMIZED CONTROLLED FEASIBILITY TRIAL

摘要

You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) I (PD15)1 Apr 2019PD15-09 TROMBONE: TESTING RADICAL PROSTATECTOMY IN MEN WITH OLIGOMETASTATIC PROSTATE CANCER THAT HAS SPREAD TO THE BONE- A RANDOMIZED CONTROLLED FEASIBILITY TRIAL Prasanna Sooriakumaran*, Prabhakar Rajan, Omar Al Kadhi, John Kelly, Jonathan Aning, Naeem Soomro, Richard Bryant, Alastair Lamb, Paul Cathcart, Oussama Elhage, Christopher Eden, Imran Ahmad, Hing Leung, Senthil Nathan, and Freddie Hamdy Prasanna Sooriakumaran*Prasanna Sooriakumaran* More articles by this author , Prabhakar RajanPrabhakar Rajan More articles by this author , Omar Al KadhiOmar Al Kadhi More articles by this author , John KellyJohn Kelly More articles by this author , Jonathan AningJonathan Aning More articles by this author , Naeem SoomroNaeem Soomro More articles by this author , Richard BryantRichard Bryant More articles by this author , Alastair LambAlastair Lamb More articles by this author , Paul CathcartPaul Cathcart More articles by this author , Oussama ElhageOussama Elhage More articles by this author , Christopher EdenChristopher Eden More articles by this author , Imran AhmadImran Ahmad More articles by this author , Hing LeungHing Leung More articles by this author , Senthil NathanSenthil Nathan More articles by this author , and Freddie HamdyFreddie Hamdy More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000555458.91980.feAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: The STAMPEDE trial has shown a survival benefit for local radiation therapy in men with oligo-metastatic prostate cancer. Observational studies have suggested such benefit may also be seen with radical prostatectomy (RP) but this has not previously been examined in a RCT. We report the world’s first RCT, TRoMbone, on the safety and feasibility of randomization to systemic therapy plus RP in synchronous oligo-metastatic prostate cancer. TRoMbone aimed to recruit 50 men over a 12-month period and was co-ordinated by the Surgical Intervention Trials Unit at the University of Oxford. METHODS: The initial Protocol randomized men with synchronous oligo-metastatic prostate cancer (1-3 skeletal metastases on conventional imaging) who were <75 years old and ECOG PS 0-1, to radical prostatectomy and extended pelvic lymphadenectomy within 3 months of starting standard care systemic therapy (Intervention) versus standard care systemic therapy alone (Control). The Protocol was amended to allow patients to have Docetaxel prior to RP, and to increase the number of recruitment sites from 3 to 9. RESULTS: Of 176 patients screened, 71 were eligible; of those, 51 (71.8%) were randomized. High recruitment rates were achieved with use of a quintet recruitment investigation (QRI). This identified the commonest causes of non-recruitment as: patients not wanting surgery; lack of clinician equipoise; and, (before the Protocol Amendment; PA) inability to have Docetaxel preoperatively. As a result of the PA, recruitment completed 4 months ahead of schedule with 7/9 (77.8%) sites successfully recruiting at least one patient (Figure). 8 surgeons performed the Intervention. Thus far, roughly half of the Intervention patients had received Docetaxel preoperatively, and all had received androgen deprivation therapy. 1 patient allocated to the Intervention did not undergo RP, as he felt too unwell post-Docetaxel. 1 patient allocated to the Control arm refused standard-care treatment, as he preferred to try Homeopathy. 100% RPs were conducted with robotic assistance, no cases were abandoned, and the only complication to date (in 18 patients) is a rectal injury (repaired intraoperatively with primary closure; that same patient was the only one who required a blood transfusion). Zero cases were abandoned, and there were no postoperative complications. Quality-of-life