Testing Surgery vs. Standard Care in Advanced Prostate Cancer: Challenges in Patient Participation

What is it about?

This study investigates the feasibility of randomizing patients with newly diagnosed metastatic prostate cancer (mPCa) to receive either cytoreductive radical prostatectomy (cRP) plus systemic standard of care (SOC) or SOC alone in Belgian centers. Conducted as a phase II, multicentre, prospective, randomised, open-label feasibility trial, the study aimed to randomize 86 patients but encountered significant challenges. Out of 325 screened patients, 170 were eligible, yet only 43 were successfully randomized, resulting in a randomization rate of 25%. Major barriers included limited surgical eligibility due to unresectable tumors and inadequate surgical fitness, as well as patient refusal. The findings underscore the difficulties in recruitment for such trials and suggest the need for tailored recruitment strategies or alternative trial designs. Despite the challenges, the study highlights important context-specific barriers in conducting trials for mPCa treatment in Belgium.

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Photo by Piron Guillaume on Unsplash

Photo by Piron Guillaume on Unsplash

Why is it important?

This research investigates the feasibility of randomising patients with newly diagnosed metastatic prostate cancer (mPCa) to either cytoreductive radical prostatectomy (cRP) plus systemic standard of care (SOC) or SOC alone in Belgian centres. The study is significant because it addresses the challenges and barriers faced in recruiting patients for clinical trials involving complex treatment strategies for mPCa. Understanding these challenges is crucial for improving future trial designs and recruitment strategies, ultimately enhancing treatment options and outcomes for patients with advanced prostate cancer. Key Takeaways: 1. The study demonstrates that randomising patients with newly diagnosed mPCa to cRP plus SOC versus SOC alone is challenging, with a low randomisation rate of 25% among eligible patients, highlighting significant recruitment barriers. 2. Findings reveal that the main obstacles to recruitment included limited surgical eligibility, with many patients having unresectable tumors or inadequate surgical fitness, and high rates of patient refusal to participate in the trial. 3. The research underscores the need for tailored recruitment strategies, such as targeted patient engagement and alternative trial designs, to overcome challenges in enrolling patients in future trials involving complex treatment regimens for metastatic prostate cancer.