RECRUITING

Hybrid Intelligence for Trustable Diagnosis and Patient Management of Prostate Cancer (HIT-PIRADS)

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Conditions

Prostate CancerElevated PSAElevated Prostate-Specific AntigenAbnormal digital rectal examProstateAIArtificial IntelligenceOncology

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Hybrid Intelligence for Trustable Diagnosis and Patient Management of Prostate Cancer (HIT-PIRADS)

Quick Facts

Study Start:2025-01
Study Completion:2028-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06804785

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Patients must be biopsy naïve, confirmed with patient or medical record.
  3. * Patients must be male, ≥18 and ≤ 89 years of age.
  4. * Patient must have a life expectancy ≥10 years, determined by PI.
  5. * Patients must exhibit an ECOG performance status of 0-2, as noted in their medical record.
  1. * Patients who are on a 5-α-reductase inhibitor within 12 months of enrollment, as confirmed by medical record.
  2. * Patients who have had a prostate infection within 1 month of enrollment, as confirmed by medical record.
  3. * 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.
  4. * Patients who've had an invasive urological procedure within 1 month of enrollment, as confirmed by their medical record and patient reporting.
  5. * Patients with no access to the rectum for a transrectal ultrasound, as determined by the Urologist.
  6. * Patients with a contraindication to magnetic resonance imaging (MRI).
  7. * Vulnerable populations: Prisoners or adult men \>89 years old.

Contacts and Locations

Study Contact

Ismail Turkbey
CONTACT
240.760.6112
ismail.turkbey@nih.gov

Study Locations (Sites)

National Institutes of Health
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01
Study Completion Date2028-05

Study Record Updates

Study Start Date2025-01
Study Completion Date2028-05

Terms related to this study

Keywords Provided by Researchers

  • Elevated PSA
  • Elevated Prostate-Specific Antigen
  • Abnormal digital rectal exam
  • Prostate Cancer
  • Prostate
  • AI
  • Artificial Intelligence
  • Oncology

Additional Relevant MeSH Terms

  • Prostate Cancer