Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: the PROFUSION Trial

Официальное название

A Randomised Controlled Trial Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of Clinically Significant Prostate Cancer: the PROFUSION Trial

Обзор

This study is an international multicentre RCT to compare the linically significant prostate cancer (csPCa) detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion.

Подробное описание

This study is an international multicentre RCT to compare the csPCa detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion. This is a phase III randomised controlled trial to evaluate the detection of clinically significant prostate cancer (csPCa) by MRI-USG fusion approach (MRUS arm) versus Cognitive-guided approach (COG arm). The study hypothesis is that MRUS arm is superior to COG arm in detecting csPCa. The result of this RCT would impact how MRI-guided prostate biopsies should be done in the future. If the MRI-USG fusion approach is superior to cognitive-guidance in csPCa detection, it should be the standard of practice in the future, and dedicated MRI-USG fusion equipment should be available in centres performing prostate biopsies.

Вмешательства

• Процедура MRI-USG fusion approach
  MRI-USG fusion approach prostate biopsy
• Процедура Cognitive-guided approach
  Cognitive-guided approach prostate biopsy

Первичные конечные точки

• Proportion of men with clinically significant Prostate cancer(csPCa) [Срок оценки: When histology results available, at an expected average of 30 days post-biopsy]

Вторичные конечные точки (8)

• Proportion of men with a diagnosis of csPCa in MRI lesions with maximal size ≤10mm versus >10mm [Срок оценки: When histology results available, at an expected average of 30 days post-biopsy]
• Proportion of men with a diagnosis of csPCa in prostate size of ≤50ml vs >50m [Срок оценки: When histology results available, at an expected average of 30 days post-biopsy]
• The proportion of men with a diagnosis of csPCa only in targeted biopsy [Срок оценки: When histology results available, at an expected average of 30 days post-biopsy]
• Proportion of men with a diagnosis of csPCa only in systemic biopsy [Срок оценки: When histology results available, at an expected average of 30 days post-biopsy]
• Proportion of men with a diagnosis of clinically insignificant PCa, [Срок оценки: When histology results available, at an expected average of 30 days post-biopsy]
• Procedure time [Срок оценки: During biopsy procedure]
• Pain score on a scale of 0-10 taken after biopsy [Срок оценки: Immediately After biopsy procedure]
• Proportion of men with post-biopsy adverse events within 30 days after biopsy [Срок оценки: 30 days post biopsy]

Критерии участия

Критерии включения

• Men ≥18 years of age
• Clinical suspicion of prostate cancer and indicated for prostate biopsy
• Serum Prostate-specific antigen (PSA) < 20 ng/mL
• Digital rectal examination ≤ cT2 (organ-confined cancer)
• Able to provide written informed consent
• MRI prostate (contrast or plain) showing 1-3 suspicious lesion(s) with PI-RADS score 3-5

Критерии исключения

• Prior prostate biopsy in the 2 years before screening visit
• Prior diagnosis of prostate cancer
• Contraindicated to prostate biopsy: active urinary tract infection, failed insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (continue low-dose aspirin before and after biopsy is permitted)
• Patient refusal for biopsy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Гонконг · 1 центр

• Prince of Wales Hospital — Гонконг

Публикации

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
• Chan SY, Ng CF, Lee KW, Yee CH, Chiu PK, Teoh JY, Hou SS. Differences in cancer characteristics of Chinese patients with prostate cancer who present with different symptoms. Hong Kong Med J. 2017 Feb;23(1):6-12. doi: 10.12809/hkmj164875. Epub 2016 Dec 9. PMID 27932742
• Wong HF, Yee CH, Teoh JY, Chan SY, Chiu PK, Cheung HY, Hou SS, Ng CF. Time trend and characteristics of prostate cancer diagnosed in Hong Kong (China) in the past two decades. Asian J Androl. 2019 Jan 1;21(1):104-106. doi: 10.4103/aja.aja_75_18. No abstract available. PMID 30178778
• Patasius A, Smailyte G. Re: MaryBeth B. Culp, Isabelle Soerjomataram, Jason A. Efstathiou, Freddie Bray, Ahmedin Jemal. Recent Global Patterns in Prostate Cancer Incidence and Mortality Rates. Eur Urol 2020;77:38-52. Eur Urol. 2020 May;77(5):e132. doi: 10.1016/j.eururo.2019.11.030. Epub 2019 Dec 13. No abstract available. PMID 31843337
• Ahdoot M, Wilbur AR, Reese SE, Lebastchi AH, Mehralivand S, Gomella PT, Bloom J, Gurram S, Siddiqui M, Pinsky P, Parnes H, Linehan WM, Merino M, Choyke PL, Shih JH, Turkbey B, Wood BJ, Pinto PA. MRI-Targeted, Systematic, and Combined Biopsy for Prostate Cancer Diagnosis. N Engl J Med. 2020 Mar 5;382(10):917-928. doi: 10.1056/NEJMoa1910038. PMID 32130814
• Chiu PK, Alberts AR, Venderbos LDF, Bangma CH, Roobol MJ. Additional benefit of using a risk-based selection for prostate biopsy: an analysis of biopsy complications in the Rotterdam section of the European Randomized Study of Screening for Prostate Cancer. BJU Int. 2017 Sep;120(3):394-400. doi: 10.1111/bju.13913. Epub 2017 Jun 5. PMID 28498624
• Heidegger I, Pichler R. Re: Peter K.-F. Chiu, Chi-Fai Ng, Axel Semjonow, et al. A Multicentre Evaluation of the Role of the Prostate Health Index (PHI) in Regions with Differing Prevalence of Prostate Cancer: Adjustment of PHI Reference Ranges is Needed for European and Asian Settings. Eur Urol 2019;75:558-61. Eur Urol. 2019 Jun;75(6):e158-e159. doi: 10.1016/j.eururo.2018.12.041. Epub 2019 Jan 5. PMID 30616947
• Chiu PK, Roobol MJ, Nieboer D, Teoh JY, Yuen SK, Hou SM, Yiu MK, Ng CF. Adaptation and external validation of the European randomised study of screening for prostate cancer risk calculator for the Chinese population. Prostate Cancer Prostatic Dis. 2017 Mar;20(1):99-104. doi: 10.1038/pcan.2016.57. Epub 2016 Nov 29. PMID 27897172

Идентификаторы

NCT: NCT06303622 · CRE-2023.610

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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