Contribution of Canine Detection in the Diagnostic Strategy of High-risk Prostate Cancer (Prostate-K9-Detect)

NCT05558735 | Unknown

• 1 other identifier: APHP220569
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

The sense of smell allows both humans and dogs to carry out a chemo-sensory analysis of their environment. Volatile organic compounds enter the nasal cavities and bind to receptors in the nasal mucosa. Neuroepithelium cells perform chemoelectric transduction of olfactory information. The latter is supported by one of the fibers of the olfactory nerve which crosses the cribriform plate of the ethmoid to arrive in the olfactory bulb of the brain. Incorporating this information can lead to behavioral responses. The dog has a sense of smell 100,000 times more sensitive than humans, it is able to detect one particle among 1 trillion. The use of detection dogs involves learning the behavioral response to an olfactory stimulus. Prostate cancer represents 25% of male cancers, it is the second deadliest cancer in France with 10,000 deaths per year. Diagnosis of prostate cancer requires a Prostate Specific Antigen (PSA) blood test and a digital rectal examination. In the event of an abnormality in one of these parameters, a prostate MRI is indicated, supplemented by prostate biopsies in the event of an abnormal MRI. However, one situation remains open to discussion: what should be done when faced with a normal MRI despite an abnormal PSA level or digital rectal examination? In this situation and according to current recommendations, the practitioner has the choice between performing prostate biopsies, i.e. an invasive procedure with a high risk of being negative, and simple monitoring, this time with the risk of missing the diagnosis of prostate cancer. Several studies have shown the effectiveness of dogs in detecting very specific volatile organic compounds. Can the investigators train them to detect the catabolites of prostate tumours?

Conditions

High-risk Prostate Cancer

Keywords

prostate cancer; canine detection; the dog's sense of smell

Outcome Measures

Primary Outcomes (1)

• "The primary outcomes measures are the sensitivity (Se) and specificity (Sp) of canine detection for the diagnosis of prostate cancer and the Kappa concordance coefficient. "

  The Se, the Sp and the kappa coefficient will be calculated for each diagnostic method (MRI and canine detection). The definitive diagnosis will be given by the results of the prostate biopsies.

  24 months

Secondary Outcomes (6)

• Calculate the Kappa coefficient quantifying the concordance between canine detection and biopsy, first among patients with negative MRI then among patients with positive MRI.

  24 months

• Show that the percentage of marking of the dog when the MRI is negative and the biopsy positive is significantly greater than 50% (correct marking by simple chance).

  24 months

• Compare the diagnostic score obtained using all the examinations carried out when prostate cancer is suspected (assay of the PSA level, digital rectal examination, MRI, prostate biopsy) with the score obtained by adding canine detection.

  24 months

• Perform a mass spectrometry examination on samples from the "case" group

  24 months

• "Compare the canine detection performances of prostate cancer (Se and Sp) according to different parameters of the patient's lifestyle, according to the different grades of cancer, and according to breeds and ages of dogs."

  24 months

Study Arms (2)

case group

The case group is composed of Adult male with a positive biopsy (Gleason score greater than or equal to 7)

Other: urine collection; Other: canine detection

control group

The control group is made up of adult men performing a biopsy whose Gleason score is less than or equal to 6.

Other: urine collection; Other: canine detection

Interventions

urine collection OTHER

urine collection as part of the care and usual follow-up in the context of suspected prostate cancer

case group; control group

canine detection OTHER

urine sample will be placed in a detection cone to be sniffed by 6 trained dogs

case group; control group

Eligibility Criteria

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

Study Population

Adult male with a positive biopsy (Gleason score greater than or equal to 7)

You may qualify if:

• Older than 18 years old
• Requiring the realization of a collection of urine from the framework of their care
• Requiring a PSA blood test, prostate MRI and prostate biopsies in the framework of their care

You may not qualify if:

• Absence of signed informed consent
• People who do not speak French
• Persons whose general condition does not allow to participate in the study
• Protected populations: under guardianship or under curatorship
• Persons deprived of their liberty by a judicial or administrative decision
• Persons receiving care psychiatric
• Absence of affiliation to a pension scheme social Security"

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Bichat - Claude-Bernard

Paris, 75018, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Urine Specimen Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Hermieu Jean-François, Surgeon

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hermieu Jean-François, Surgeon

CONTACT

0140257103; jean-françois.hermieu@aphp.fr

de la Taille Alexandre, Surgeon

CONTACT

0149812554; alexandre.de-la-taille@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 28, 2022
• Study Start: November 2, 2022
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 25, 2023

Record last verified: 2022-09

Locations

FR (1)