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Randomized trials of PSA screening
Priya Dave1, Sigrid V Carlsson2, Kara Watts1
1Department of Urology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY.
Urologic Oncology
|June 26, 2024
Summary
Prostate-specific antigen (PSA) screening for prostate cancer shows mixed results. While some trials found no mortality benefit, the ERSPC trial demonstrated a significant reduction in prostate cancer deaths, highlighting the need for optimized screening strategies.
Area of Science:
- Urology
- Oncology
- Public Health
Background:
- Prostate-specific antigen (PSA) testing's role in prostate cancer (PCa) screening has evolved, with randomized controlled trials (RCTs) influencing guidelines.
- Current controversy surrounds PSA screening due to the indolent nature of many PCa cases and risks of overdiagnosis and overtreatment.
Purpose of the Study:
- To review major RCTs evaluating PSA screening to inform clinical practices.
- To analyze the impact of PSA screening on prostate cancer mortality and incidence.
Main Methods:
- Summarized findings from primary RCTs: Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, European Randomized Study of Screening for Prostate Cancer (ERSPC), and Cluster Randomized Trial of PSA Testing for Prostate Cancer (CAP).
- Evaluated PSA screening's effect on PCa mortality and incidence, noting study limitations like contamination and low compliance.
Main Results:
- PLCO and CAP trials showed no significant difference in PCa mortality.
- ERSPC trial reported a 20% reduction in PCa mortality at 9 years and a decrease in metastatic disease.
- PLCO trial indicated increased detection of Gleason 6 and decreased detection of Gleason 8-10 disease in the screening group.
Conclusions:
- Differences in trial outcomes are attributed to variations in design, contamination, adherence, and PSA thresholds.
- Further research is needed to optimize screening intervals, target high-risk groups, and integrate non-invasive tools for improved efficacy and reduced harms.
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Randomized Experiments
The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
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Simple randomization
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Blinding
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.

