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Cancer research

Asan Medical Center Develops Patient-Tailored Prostate Cancer Diagnostic Protocol

Strategic Insights

— 1 min read

Asan Medical Center, a major hospital in South Korea, has registered a clinical trial with the Clinical Research Information Service (CRiS) for the development of a patient-tailored prostate cancer diagnostic protocol using magnetic resonance imaging (MRI) and biomarkers. The study aims to reduce unnecessary biopsies, enhance high-risk prostate cancer detection, and improve the domestic prostate cancer diagnostic system. This clinical trial will evaluate the appropriateness of prostate biopsy candidates using MRI and the Prostate Health Index (PHI) in patients with elevated serum Prostate-Specific Antigen (PSA) levels.

Key Takeaways:

  • The clinical trial aims to develop a patient-tailored prostate cancer diagnostic protocol using MRI and biomarkers to reduce unnecessary biopsies and enhance high-risk prostate cancer detection.
  • The study will assess a combined strategy using MRI and PHI to identify clinically significant cases of prostate cancer before biopsy.
  • The diagnostic protocol will be compared to the standard 12-core TRUS-guided biopsy to determine the detection rate of clinically significant prostate cancer (Gleason score ≥ 3+4).
  • The study will recruit adult males with elevated PSA (3-20 ng/mL) or suspected prostate cancer based on digital rectal examination.
  • The primary efficacy endpoint is the comparison of the proportion of clinically significant prostate cancer (Gleason score ≥ 3+4) between the study groups.
  • Secondary efficacy endpoints include the proportion of clinically insignificant cancer (Gleason score 6), biopsy omission rate, distribution of MRI scores for prostate cancer risk lesions, and incidence of post-biopsy adverse events.
  • The study will utilize MRI, Prostate Health Index (PHI), Standard 12-core biopsy, MRI-target biopsy, and blood tests as interventions.
  • The clinical trial registration number is KCT0010854, and the study has been registered with the Clinical Research Information Service (CRiS).

Statistics:

  • The study aims to recruit adult males with elevated PSA levels (3-20 ng/mL) or suspected prostate cancer based on digital rectal examination.
  • The primary efficacy endpoint will be the comparison of the proportion of clinically significant prostate cancer (Gleason score ≥ 3+4) between the study groups.
  • Secondary efficacy endpoints include the proportion of clinically insignificant cancer (Gleason score 6), biopsy omission rate, and incidence of post-biopsy adverse events.

Sources:

  • Clinical Research Information Service (CRiS) - Republic of Korea
  • Clinical trial registration number: KCT0010854
  • Registration URL: https://cris.nih.go.kr/cris/search/detailSearch.do?seq=30857&search_page=L

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