Protocol Details
Hybrid Intelligence for Trustable Diagnosis and Patient Management of Prostate Cancer (HIT-PIRADS)
This study is NOT currently recruiting participants.
Summary
Number |
001718-C |
Sponsoring Institute |
National Cancer Institute (NCI) |
Recruitment Detail |
Type: Recruitment has not started
Gender: Male
Min Age: 18 Years
Max Age: 120 Years |
Referral Letter Required |
No |
Population Exclusion(s) |
Female;
Children;
Neonates;
Pregnant Women;
Fetuses |
Keywords |
Artificial Interlligence;
Diagnosis;
Multiparametric MRI |
Recruitment Keyword(s) |
None |
Condition(s) |
Prostate Cancer;
Intraprostatic Lesions |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
Device: HIT-PIRADS
|
Supporting Site |
National Cancer Institute |
Background:
Prostate cancer is one of the most common cancers in men worldwide; 11% of US men will develop this cancer over their lifetime. A tool that uses magnetic resonance imaging (MRI) scans is typically used to diagnose prostate cancer. But this tool can miss dangerous cancers; it can also overdetect more minor ones. Researchers want to use artificial intelligence (AI) to create a more accurate tool.
Objective:
To develop a new imaging tool for more precise detection of prostate cancer.
Eligibility:
Men aged 18 to 89 years with an increased risk of prostate cancer. This risk can be defined by either blood tests or an abnormal rectal exam.
Design:
Researchers will collect data from participants medical records. The records will be from their normal care at the NIH clinic. No new procedures will be done for this study. Data to be collected will include clinical; demographic; laboratory; and imaging records.
Data may continue to be collected for up to 4 years.
Researchers will use all the data and images to create AI algorithms for detecting prostate cancer.
Eligibility
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 their lab report.
-Patients must be biopsy na(SqrRoot) ve, 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-alpha-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.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT06804785