[Studies on localized low-risk prostate cancer : Do we know enough?]

Area of Science:

• Oncology
• Clinical Research Methodology

Background:

• Localized low-risk prostate cancer (PCa) treatment is shifting from invasive methods (surgery, radiation) to conservative approaches.
• Active surveillance (AS) and watchful waiting (WW) are emerging as preferred strategies for managing low-risk PCa.

Purpose of the Study:

• To critically evaluate the significance of existing studies on AS and WW for low-risk prostate cancer.
• To identify limitations in current research methodologies for assessing conservative PCa management strategies.

Main Methods:

• Critical appraisal of prominent AS studies, focusing on input criteria, follow-up protocols, and statistical power.
• Analysis of challenges inherent in randomized controlled trials (RCTs) for conditions with low tumor-specific mortality.

Main Results:

• Randomized studies often struggle with statistical significance and power when evaluating treatments for low-risk cancers due to low event rates.
• Renowned trials like PIVOT and ProtecT exhibit systematic and statistical shortcomings, limiting their applicability.
• RCTs may create select patient cohorts that do not reflect real-world clinical practice.

Conclusions:

• Evaluating the optimal treatment for low-risk prostate cancer requires extensive time and large participant numbers in RCTs due to low mortality.
• Alternative statistical methods, such as propensity scores, may be more suitable for real-world healthcare research in this area.
• Future studies should prioritize real-world conditions over traditional RCT designs to yield clinically relevant results for low-risk PCa management.