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AI Algorithm-Informed Biopsy for Prostate Cancer Detection With Indeterminate and Low-Risk Prostate MRI Lesions

A Prospective Randomized Phase I/II Study of Artificial Intelligence Algorithm-Informed Biopsy for Detection of Prostate Cancer in Patients With Indeterminate and Low-risk Prostate MRI Lesions

Who can join

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

Age
40 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: Biopsies

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
  • "Assess the acceptance rate of randomization and biopsy recommendations based on study protocol and AI algorithm results by the patients."
  • "Evaluate the per-patient and per-lesion csPCa detection rates of AI algorithm-informed biopsy (the intervention arm) versus contemporary biopsy (the control arm) in patients randomly allocated 1:1 to each arm."
  • "Evaluate benign and clinically non-significant PCa rates (GS \<7) in patients who underwent AI-algorithm informed (the intervention arm) versus contemporary (the control arm) prostate biopsies. 2."
  • "Evaluate the specificity and sensitivity of AI algorithm-informed biopsy (AI-targeted and perilesional prostate biopsy) versus contemporary biopsy in detection of csPCa. 3."
  • "Obtain and evaluate adverse events (AEs), urinary function (IPSS), sexual function (IIEF) quality of life (QOL) \[ SF-12 and TMI scores\] and decision regret (DRS) measures on subjects that underwent contemporary biopsy versus AI Algorithm-informed biopsy."
  • "Collect data via genomic and transcriptomic approaches (Whole exome sequencing + Targeted RNA sequencing OR single cell RNA sequencing) in patients whose standard contemporary biopsy, perilesional biopsy and AI-targeted biopsy revealed csPCa, and compare collected data on all endpoints for differences among perilesional biopsy, AI-targeted biopsy and contemporary standard 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

In plain language

This study tests whether artificial intelligence (AI) can help guide prostate biopsies to find prostate cancer that may need treatment. A biopsy takes small tissue samples for testing. The study is for men age 40 or older with unclear prostate MRI findings, or low-risk findings plus signs of higher cancer risk.

Use of AI algorithm for PCa detection is feasible, and AI-informed biopsies (AI-targeted and perilesional biopsy) improves csPCa detection in patients with indeterminate MRI lesions and in patients with low-risk MRI lesions and high-risk clinical features.

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

Eligibility

Who can join

  • Be a man age 40 or older. Men of all races and ethnic groups may join.
  • Have had a prostate MRI scan within the past 12 weeks.
  • Be fully active, or able to walk and do light work despite limits on hard physical activity (ECOG score 0–1).
  • Have a raised PSA blood test: at least 3.0 ng/ml at ages 40–75, or at least 4.0 ng/ml above age 75. PSA is a protein made by the prostate.
  • Have unclear MRI findings (PI-RADS 3), or low-risk findings (PI-RADS 1–2). For low-risk findings, you must also have at least one risk factor listed below.
  • Risk factors include PSA high for the prostate's size (PSA density at least 0.15 ng/ml/g), a concerning rectal exam, or a blood or urine test showing higher cancer risk.
  • Other risk factors include Black/African American ancestry, inherited gene changes that raise prostate cancer risk, or a significant personal or family medical history.
  • Another risk factor is PSA that stays high for at least 12 months and at least doubles within 24 months, with the latest level confirmed twice.

Who can't join

  • Be younger than 18. The entry rules separately require age 40 or older.
  • Have MRI findings that strongly suggest cancer (PI-RADS 4–5).
  • Have prostate cancer already found by biopsy with a Gleason score of 7 (3+4) or higher, a measure of how aggressive the cancer looks.
  • Have prostate cancer managed with close monitoring, surgery, or radiation. An exception allows some men with only Gleason 6 (3+3) cancer found on a standard biopsy, no prior prostate MRI, and a need for a biopsy to confirm the diagnosis.
  • Be unable to safely receive anesthesia, or have a medical history that prevents a prostate MRI or biopsy.
  • Have had an allergic reaction to scan contrast dye or a substance with a similar chemical makeup.
  • Have a condition that makes MRI images less clear, such as an artificial hip or too much gas in the rectum.
  • Have any other condition that the study doctor thinks could make taking part unsafe.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. 40 years of age or older. 2. A recent pMRI performed within last 12 weeks 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1. 4. Any patient with PIRADS 3 lesions per pMRI, AND elevated PSA ("=\> 3.0 ng/ml" for patients between 40 and 75 years old, and "=\> 4.0 ng/ml" for the patients older than 75 years). 5. Patients with PIRADS 1-2 lesions per pMRI, AND elevated PSA ("=\> 3.0 ng/ml" for patients between 40 and 75 years old, and "=\> 4.0 ng/ml" for the patients older than 75 years), AND at least one of the following: 1. High PSA density (0.15 ng/ml/g or higher), 2. suspicious DRE, 3. a positive/high-risk blood or urine biomarker test, 4. high-risk ancestry (Black/African American), 5. those with germline mutations that increase the risk for prostate cancer, 6. significant personal medical history, 7. significant family history, 8. persistent and significant increase in PSA levels (persistently elevated PSA for at least 12 months with an increase of at least 100% or more within 24 months, last level confirmed twice). Exclusion Criteria: 1. Patients younger than 18 years old. 2. Any patient with PIRADS 4-5 lesion per pMRI. 3. Any patient with known csPCa (GS ≥7 (3+4)) per biopsy. 4. Any patient with PCa and managed with active surveillance, surgery or radiation. a. (Patients who never scanned with pMRI before, had GS 6 (3+3) PCa only per systematic biopsy, and currently need confirmatory prostate biopsy will be allowed to enroll in the trial). 5. Medically unfit for anesthesia. 6. Any history of allergic reactions attributed to contrast agents, or other compounds of similar chemical compositions. 7. Any medical history preventing pMRI or prostate biopsy. 8. Any medical condition distorting quality of pMRI such as artificial hip prosthesis, and excessive rectal gas. 9. Any other condition that, in the opinion of the investigator, might interfere with the safe conduct of the study. Inclusion of Women and Minorities: All participants will be men without previous diagnosis for PCa. Men of all ethnic groups and races are eligible for the study. Thus, women will not be included in this study.

Study sites (1)

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