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Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer

MRI-targeted Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, Biopsies, Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The MRI-targeted biopsy for prostate cancer detection can be performed using one of two techniques: 1."
  • "Software-based fusion of MRI and ultrasound images (software fusion) or 2."
  • "Visually estimated MRI-informed (cognitive fusion) technique To date, there is a lack of adequately powered RCTs directly comparing the cognitive vs fusion targeted biopsy."
  • "This randomized study will directly compare the detection rates of clinically significant prostate cancer following either the cognitive or the fusion targeted prostate biopsy in men with suspicious lesions noted on multi-parametric MRI (mp-MRI) of prostate."
  • "For prostate cancer detection, pre-biopsy multi-parametric magnetic resonance imaging (mp-MRI) followed by MRI-targeted prostate biopsy is standard of care which is supported by the guidelines from the American Urological Association and the European Association of Urology."
  • "The MRI-targeted prostate biopsy is associated with a significant increase in the detection of clinically significant prostate cancer (csPCa) compared to the ultrasound guided biopsy."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

The MRI-targeted biopsy for prostate cancer detection can be performed using one of two techniques: 1. Software-based fusion of MRI and ultrasound images (software fusion) or 2. Visually estimated MRI-informed (cognitive fusion) technique To date, there is a lack of adequately powered RCTs directly comparing the cognitive vs fusion targeted biopsy. This randomized study will directly compare the detection rates of clinically significant prostate cancer following either the cognitive or the fusion targeted prostate biopsy in men with suspicious lesions noted on multi-parametric MRI (mp-MRI) of prostate.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * Men undergoing prostate biopsy (either transrectal or transperineal) for suspected prostate cancer as part of their regular medical care * Must be eligible to undergo both prostate biopsy procedure (cognitive or fusion) * Men undergoing their first prostate biopsy procedure or with no previous prostate biopsy within 3 years * Pre-biopsy mp-MRI of prostate with one or more lesions classified as PIRADS 3-5 * Largest dimension of any lesion on mp-MRI to be ≤ 2 cm * Prostate-specific antigen level ≤ 20 ng/mL and/or abnormal digital rectal examination Exclusion Criteria: * mp-MRI detected lesions that are \> 2 cm * History of prostate biopsy within 3 years * Previous diagnosis of prostate cancer * Contraindications to prostate biopsy (eg, fever, evidence of genito-urinary infection, excessive co-morbidities as per treating physician)

Study sites (3)

MA

NY

PA