An interventional study of Software fusion prostate biopsy and Cognitive fusion prostate biopsy in Prostate Cancer and Diagnosis, sponsored by Albany Medical College. Recruiting at 4 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by Albany Medical College · Not applicable, Interventional, and Diagnostic
The MRI-targeted biopsy for prostate cancer detection can be performed using one of two techniques:
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. The MRI-targeted biopsy can be performed using one of two techniques including software-based fusion of MRI and ultrasound images (software fusion) or visually guided MRI-informed (cognitive fusion) technique.
With regards to the diagnostic performance in detecting csPCa, current literature does not demonstrate a clear advantage to one targeting technique over the other. A systematic review and meta-analysis (published in early 2024) by Falagario et al evaluated all of the comparative studies of the above-mentioned MRI-targeting techniques. Of the 20 studies included, six reported improved detection of csPCa with fusion technique, one reported an advantage to the cognitive technique, while thirteen reported no significant difference. Of note, the majority of the studies were retrospective, with high risk of bias, that lacked uniform definition of csPCa, and employed variable mp-MRI technique (1.5T vs 3T) and scoring system (Likert vs PIRADS). There were only three small, prospective, randomized studies (RCT) available in the systematic review of literature. One RCT reported the fusion technique to be superior while two demonstrated no difference in csPCa detection rates. There was no significant difference in the detection of csPCa between the targeting techniques, however, low quality of evidence and heterogeneity warranted well-designed prospective studies.
Other studies, as well as personal experience, point to somewhat improved cancer detection the cognitive MRI-targeting approach, although the rates may be affected by patient selection related to lesion size and location.
Thus, the investigators are conducting an RCT to direct compare the csPCa detection rates following either the cognitive or the fusion targeted prostate biopsy in men with suspicious lesions noted on mp-MRI of prostate. The investigators hypothesize that the diagnostic accuracy MRI-targeted prostate biopsy using cognitive fusion technique is either similar to or not significantly inferior to the software fusion technique.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 1,306 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Albany Medical College is the lead sponsor of 81 studies on the registry; 14 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Software fusion biopsy: Biopsy of the MRI-detected lesion using an image fusion platform such as UroNav or similar.
Procedure: Software fusion prostate biopsy
Cognitive fusion biopsy: Biopsy of the MRI-detected lesion using visual estimation and/or measurements to identify landmarks and lesions.
Procedure: Cognitive fusion prostate biopsy
Software fusion biopsy: Each participant in this study arm will first undergo biopsy of the MRI-detected lesion using an image fusion platform such as UroNav or similar. Three biopsy cores will be taken per lesion, with a maximum of three lesions being sampled per participant. Then systematic samples will be taken from the remainder of the prostate as per standard protocol (10-12 cores).
Cognitive fusion biopsy: Each participant in this study arm will first undergo biopsy of the MRI-detected lesion using visual estimation and/or measurements of lesion. Three biopsy cores will be taken per lesion, with a maximum of three lesions being sampled per participant. Then systematic samples will be taken from the remainder of the prostate as per standard protocol (10-12 cores).
Also known as: Visual estimation fusion prostate biopsy
Detection of clinically significant prostate cancer
Compare the overall detection of clinically significant prostate cancer following fusion vs cognitive MRI-targeted biopsy
Time frame: 1 year
Detection of clinically significant prostate cancer in the targeted cores, systematic biopsy cores, and combined
Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy
Time frame: 1 year
Detection of clinically significant prostate cancer based on lesion size (< 0.5 cm; 0.5 cm to 1 cm; > 1.1 cm etc)
Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy
Time frame: 1 year
Detection of clinically significant prostate cancer at various lesion location (anterior, posterior, apex, base)
Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy
Time frame: 1 year
Detection rate of overall prostate cancer of any grade
Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy
Time frame: 1 year
Detection rate of clinically insignificant (low grade) prostate cancer
Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy
Time frame: 1 year
Detection rate of clinically significant prostate cancer based on PSA density (PSA level / prostate volume)
Compare the detection of prostate cancer following fusion vs cognitive MRI-targeted biopsy
Time frame: 1 year
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Albany Medical College