Clinical trial · Observational
Hybrid Intelligence for Trustable Diagnosis and Patient Management of Prostate Cancer (HIT-PIRADS)
NCT06804785CI-TRIAL-00124467HIT-PIRADSwithdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to funding issues the study did not move forward with prospective enrollment
Summary
Brief summary (as posted)
The purpose of this study is to develop a new way to diagnose prostate cancer through the use of artificial intelligence. The goal is for this new method to reduce delays in diagnoses and to avoid invasive procedures such as biopsies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Cohort 1
- description
- Biopsy naïve participants with elevated PSA (4.0-10.0 ng/ml) or abnormal digital rectal exam with PSA of 2.00-10.00 ng/ml as indicated in their lab report.
Primary outcomes (1)
- measure
- Number of Participants with detection of clinically significant prostate cancer (csPCa)
- timeFrame
- 01/01/2016-12/31/2026
- description
- csPCa is defined as PCa with a Gleason Grade Group of 2 through 5 found on prostate biopsy. Detection of csPCa will be compared for HITPIRADS vs. PIRADS v2.1 with a focus on suspicious lesions.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * Elevated PSA (4.0-10.0 ng/ml) or abnormal digital rectal exam with PSA of 2.00-10.00 ng/ml as indicated in the patient's lab report. * Patients must be biopsy naïve, confirmed with patient or medical record. * Patients must be male, ≥18 and ≤ 89 years of age. * Patient must have a life expectancy ≥10 years, determined by PI. * Patients must exhibit an ECOG performance status of 0-2, as noted in their medical record. Exclusion Criteria: * Patients who are on a 5-α-reductase inhibitor within 12 months of enrollment, as confirmed by medical record. * Patients who have had a prostate infection within 1 month of enrollment, as confirmed by medical record. * Patients who are receiving or who received prostate cancer treatment (e.g., androgen deprivation therapy, surgery, radiation therapy or adjuvant/neoadjuvant therapy with investigational drugs) per their medical record. * Patients who've had an invasive urological procedure within 1 month of enrollment, as confirmed by their medical record and patient reporting. * Patients with no access to the rectum for a transrectal ultrasound, as determined by the Urologist. * Patients with a contraindication to magnetic resonance imaging (MRI). * Vulnerable populations: Prisoners or adult men \>89 years old.
References
Publications (0)
Data not yet available
No reference posted for this study.