Objectives

To test feasibility of randomisation to radical prostatectomy plus pelvic lymphadenectomy (RP) 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 tertiary-care nationwide 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 versus SOC plus RP (intervention arm).

The main outcome measures were: ability to randomise participants, optimised by a QRI. EQ-5D-5L questionnaires to capture quality-of-life (QOL) data at baseline and three months post-randomisation; routine clinico-pathological assessment to capture adverse events and prostate-specific antigen in both arms, plus standard peri-operative parameters in the surgical arm.

Results

51 men were randomised within 14 months (one was subsequently deemed ineligible), with 60-83% accrual rate in centres that recruited at least two participants. All participants completed the trial follow-up; one participant 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.

Discussion

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 multi-modality management of oligo-metastatic prostate cancer.