Evaluation of the PROSTia Test in Patients Undergoing Prostate Biopsy

NCT06931496 | Not Yet Recruiting

• 1 other identifier: 2024-A02305-42
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are interested here in the contribution of a new prostate cancer screening method and, more specifically, in the new and somewhat futuristic approach of artificial intelligence in the development of new, more accurate algorithms that make it possible to rethink the benefits of mass generalisation of prostate biopsies. Main objective The main objective of this research is to use artificial intelligence and an associated algorithm to identify new indicators that would make it possible to avoid a prostate biopsy in patients with an initial suspicion of prostate cancer.

Conditions

Prostate Cancer (Adenocarcinoma)

Keywords

prostate cancer; risk calculator; Artificial intelligence

Outcome Measures

Primary Outcomes (8)

• sensitivity

  Measuring the sensitivity of the test in comparison with the results of prostate biopsies

  Immediately after to notification of prostate biopsy results.

• specificity

  Measuring the specificity of the test in comparison with the results of prostate biopsies

  Immediately after to notification of prostate biopsy results.

• positive likehood ratio

  Measuring the positive likehood ratio of the test in comparison with the results of prostate biopsies

  Immediately after to notification of prostate biopsy results.

• negative likehood ratio

  Measuring the negative likehood ratio of the test in comparison with the results of prostate biopsies

  Immediately after to notification of prostate biopsy results.

• disease prevalence

  Measuring the disease prevalence of the test in comparison with the results of prostate biopsies

  Immediately after to notification of prostate biopsy results.

• positive predictive value

  Measuring the positive predictive value with the results of prostate biopsies

  Immediately after to notification of prostate biopsy results.

• negative predictive value

  Measuring the negative predictive value with the results of prostate biopsies

  Immediately after to notification of prostate biopsy results.

• accuracy

  Measuring the accuracy of the test in comparison with the results of prostate biopsies

  Immediately after to notification of prostate biopsy results.

Secondary Outcomes (2)

• ability of the test to detect clinically significant cancers (ISUP ≥ 2)

  Immediately after to notification of prostate biopsy results.

• failure rate of the test to detect the most aggressive cancers (ISUP 4 and 5)

  Immediately after to notification of prostate biopsy results.

Study Arms (1)

Prostia test

EXPERIMENTAL

patients who responded to the PROSTia questionnaire

Other: PROSTia test

Interventions

PROSTia test OTHER

questionnaire with 50 questions

Prostia test

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients followed up at the Nancy CHRU in the Urology Department and eligible for a prostate biopsy in search of prostate cancer, taking into account an increase in PSA, PSA density, lesion on MRI.
• Person who has received full information about the organisation of the research and has not objected to their participation and the use of their data.
• Adult male over 18 years of age - Patient affiliated to or benefiting from a social security scheme - Patient who understands French and is able to fill in a self-administered questionnaire or who has the possibility to be assisted in filling it in.

You may not qualify if:

• Patients who have already had a prostate biopsy
• Patients under court protection, guardianship or trusteeship
• Patients deprived of liberty by judicial or administrative decision

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, France, 54500, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Pascal Principal investigator, MD PhD

CONTACT

+33 614717277; p.eschwege@chru-nancy.fr

Clément c Secondary investigator, MD MsC

CONTACT

+1 418 933 66 57; c.larose@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 17, 2025
• Study Start: April 15, 2025
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

FR (1)