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Recruiting NCT06303622

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

No phase Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI-USG fusion approach, Cognitive-guided approach.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Proportion of men with clinically significant Prostate cancer(csPCa) [Time frame: When histology results available, at an expected average of 30 days post-biopsy]
Secondary outcome measures (8)
  • Proportion of men with a diagnosis of csPCa in MRI lesions with maximal size ≤10mm versus >10mm [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: When histology results available, at an expected average of 30 days post-biopsy]
  • Proportion of men with a diagnosis of clinically insignificant PCa, [Time frame: When histology results available, at an expected average of 30 days post-biopsy]
  • Procedure time [Time frame: During biopsy procedure]
  • Pain score on a scale of 0-10 taken after biopsy [Time frame: Immediately After biopsy procedure]
  • Proportion of men with post-biopsy adverse events within 30 days after biopsy [Time frame: 30 days post biopsy]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Hong Kong · 1 center
  • Prince of Wales Hospital — Hong Kong

Publications

  • 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

Identifiers

NCT: NCT06303622 · CRE-2023.610

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗