PD15-09\u2003TROMBONE: TESTING RADICAL PROSTATECTOMY IN MEN WITH OLIGOMETASTATIC PROSTATE CANCER THAT HAS SPREAD TO THE BONE- A RANDOMIZED CONTROLLED FEASIBILITY TRIAL

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 data demonstrated equivalence in EQ5D scores between the Control and Intervention groups, and satisfaction scores were high even in those who received ADT, Docetaxel, and RP. CONCLUSIONS: It is feasible to randomize UK men with synchronous oligo-metastatic prostate cancer to standard care systemic therapy versus that plus locally-directed surgery. Interim outcomes suggest the procedure is safe and technically feasible, and a full RCT is being planned. Source of Funding: Prostate Cancer Foundation The Urology Foundation