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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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Risk-adjusted Screening for Prostate Cancer-Defining the Low-risk Group by Data from the PROBASE Trial.

Agne Krilaviciute1, Rudolf Kaaks2, Petra Seibold1

  • 1Division of Personalized Early Detection of Prostate Cancer, German Cancer Research Center (DKFZ), Heidelberg, Germany.

European Urology
|May 15, 2024
PubMed
Summary
This summary is machine-generated.

Men aged 45 with a baseline prostate-specific antigen (PSA) level below 1.5 ng/ml have a very low risk of prostate cancer (PCa) over the next five years. These findings support risk-adjusted screening strategies for PCa in younger men.

Keywords:
Low riskProstate cancerProstate-specific antigenScreening

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Area of Science:

  • Urology
  • Oncology
  • Screening and Diagnostics

Background:

  • Risk-adjusted screening for prostate cancer (PCa) aims to minimize harms by adjusting retesting frequency, particularly for low-risk individuals.
  • Current definitions of low risk are primarily based on studies involving men aged 55-60 years initiating screening.

Purpose of the Study:

  • To identify men at age 45 with a low risk of developing prostate cancer (PCa).

Main Methods:

  • The study utilized a population-based, risk-adjusted PCa screening trial (PROBASE) in Germany.
  • Baseline prostate-specific antigen (PSA) measurements were taken starting at age 45.
  • The incidence of PCa within 5 years was assessed in relation to baseline PSA levels (<1.5 ng/ml vs. 1.5-3.0 ng/ml).

Main Results:

  • Among 23,301 men tested at age 45, 0.79% had a PSA ≥3 ng/ml.
  • Men with a baseline PSA <1.5 ng/ml (89% of participants) had a subsequent positive PSA test rate of only 0.45% over 5 years.
  • Men with a baseline PSA of 1.5-3.0 ng/ml showed a significantly higher rate (13%) of exceeding 3 ng/ml within 4 years.
  • PCa incidence increased with baseline PSA levels, ranging from 0.13 to 8.0 per 1000 person-years.

Conclusions:

  • Men with a baseline PSA <1.5 ng/ml at age 45 demonstrate a very low risk of PCa over the subsequent 5 years.
  • These results suggest that men with a baseline PSA <1.5 ng/ml at age 45 may not require PSA retesting within this 5-year period.
  • The findings support the application of risk-adjusted screening protocols for prostate cancer in younger men.