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Article

Single‑center, retrospective, evaluator‑blinded, pilot and pivotal clinical trials: Assessing the mirCaP Kit (hsv2‑miR‑H9/hsa‑miR‑3659) as a diagnostic marker for prostate cancer in patients with PSA levels in the gray zone

  • Authors:
    • Won Tae Kim
    • Kyeong Kim
    • Ho Won Kang
    • Young Joon Byun
    • Xuan-Mei Piao
    • Yong-June Kim
    • Sang Cheol Lee
    • Seok Joong Yun
    • Yun-Sok Ha
    • Jiyeon Kim
    • Isaac Yi Kim
  • View Affiliations / Copyright

    Affiliations: Department of Urology, College of Medicine, Chungbuk National University, Cheongju, Chungbuk 28644, Republic of Korea, Department of Urology, Chungbuk National University Hospital, Cheongju, Chungbuk 28644, Republic of Korea, Department of Urology, School of Medicine, Kyungpook National University, Daegu, North Gyeongsang 41404, Republic of Korea, Department of Urology, Yale School of Medicine, New Haven, CT 06510, USA
  • Article Number: 23
    |
    Published online on: October 23, 2024
       https://doi.org/10.3892/ol.2024.14770
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Abstract

Prostate‑specific antigen (PSA) remains a key biomarker for the diagnosis and monitoring of prostate cancer (PCa). For patients within the ‘PSA gray zone’, the positive predictive value (PPV) of PSA for PCa detection by biopsy is estimated to be between 30 and 42%. In the present study, a single‑center, retrospective, evaluator‑blinded, pilot and pivotal clinical trial was performed to assess the clinical performance of the mirCaP kit (Urotech, Inc.), which measures the herpes simplex virus 2‑microRNA (miR)‑H9/hsa‑miR‑3659 ratio, with respect to helping physicians make appropriate decisions regarding further assessment of patients with PSA levels within this gray zone. For the patients in the initial clinical trial group who were in the PSA gray zone, the sensitivity, specificity, accuracy, PPV and negative predictive value (NPV) of the mirCaP kit were 94.29, 77.50, 85.33, 78.57 and 93.94%, respectively. For those in the pivotal clinical trial, these values were 94.50, 82.73, 87.90, 81.10 and 95.04%, respectively. These results suggest that the mirCaP kit may be an effective non‑invasive diagnostic marker for PCa in patients with PSA levels in the gray zone. Thus, the mirCaP kit is a promising tool that can help physicians make a decision regarding the need for prostate biopsy in these patients. Of note, the NPV of >90% indicates that the mirCaP kit could prevent unnecessary prostate biopsies in >90% of these cases.
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Copy and paste a formatted citation
Spandidos Publications style
Kim WT, Kim K, Kang H, Byun Y, Piao X, Kim Y, Lee S, Yun S, Ha Y, Kim J, Kim J, et al: Single‑center, retrospective, evaluator‑blinded, pilot and pivotal clinical trials: Assessing the mirCaP Kit (hsv2‑miR‑H9/hsa‑miR‑3659) as a diagnostic marker for prostate cancer in patients with PSA levels in the gray zone. Oncol Lett 29: 23, 2025.
APA
Kim, W.T., Kim, K., Kang, H., Byun, Y., Piao, X., Kim, Y. ... Kim, I. (2025). Single‑center, retrospective, evaluator‑blinded, pilot and pivotal clinical trials: Assessing the mirCaP Kit (hsv2‑miR‑H9/hsa‑miR‑3659) as a diagnostic marker for prostate cancer in patients with PSA levels in the gray zone. Oncology Letters, 29, 23. https://doi.org/10.3892/ol.2024.14770
MLA
Kim, W. T., Kim, K., Kang, H., Byun, Y., Piao, X., Kim, Y., Lee, S., Yun, S., Ha, Y., Kim, J., Kim, I."Single‑center, retrospective, evaluator‑blinded, pilot and pivotal clinical trials: Assessing the mirCaP Kit (hsv2‑miR‑H9/hsa‑miR‑3659) as a diagnostic marker for prostate cancer in patients with PSA levels in the gray zone". Oncology Letters 29.1 (2025): 23.
Chicago
Kim, W. T., Kim, K., Kang, H., Byun, Y., Piao, X., Kim, Y., Lee, S., Yun, S., Ha, Y., Kim, J., Kim, I."Single‑center, retrospective, evaluator‑blinded, pilot and pivotal clinical trials: Assessing the mirCaP Kit (hsv2‑miR‑H9/hsa‑miR‑3659) as a diagnostic marker for prostate cancer in patients with PSA levels in the gray zone". Oncology Letters 29, no. 1 (2025): 23. https://doi.org/10.3892/ol.2024.14770
Copy and paste a formatted citation
x
Spandidos Publications style
Kim WT, Kim K, Kang H, Byun Y, Piao X, Kim Y, Lee S, Yun S, Ha Y, Kim J, Kim J, et al: Single‑center, retrospective, evaluator‑blinded, pilot and pivotal clinical trials: Assessing the mirCaP Kit (hsv2‑miR‑H9/hsa‑miR‑3659) as a diagnostic marker for prostate cancer in patients with PSA levels in the gray zone. Oncol Lett 29: 23, 2025.
APA
Kim, W.T., Kim, K., Kang, H., Byun, Y., Piao, X., Kim, Y. ... Kim, I. (2025). Single‑center, retrospective, evaluator‑blinded, pilot and pivotal clinical trials: Assessing the mirCaP Kit (hsv2‑miR‑H9/hsa‑miR‑3659) as a diagnostic marker for prostate cancer in patients with PSA levels in the gray zone. Oncology Letters, 29, 23. https://doi.org/10.3892/ol.2024.14770
MLA
Kim, W. T., Kim, K., Kang, H., Byun, Y., Piao, X., Kim, Y., Lee, S., Yun, S., Ha, Y., Kim, J., Kim, I."Single‑center, retrospective, evaluator‑blinded, pilot and pivotal clinical trials: Assessing the mirCaP Kit (hsv2‑miR‑H9/hsa‑miR‑3659) as a diagnostic marker for prostate cancer in patients with PSA levels in the gray zone". Oncology Letters 29.1 (2025): 23.
Chicago
Kim, W. T., Kim, K., Kang, H., Byun, Y., Piao, X., Kim, Y., Lee, S., Yun, S., Ha, Y., Kim, J., Kim, I."Single‑center, retrospective, evaluator‑blinded, pilot and pivotal clinical trials: Assessing the mirCaP Kit (hsv2‑miR‑H9/hsa‑miR‑3659) as a diagnostic marker for prostate cancer in patients with PSA levels in the gray zone". Oncology Letters 29, no. 1 (2025): 23. https://doi.org/10.3892/ol.2024.14770
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