High-risk Prostate CancerNCT05558735
Contribution of Canine Detection in the Diagnostic Strategy of High-risk Prostate Cancer (Prostate-K9-Detect)
An observational study of High-risk Prostate Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- High-risk Prostate Cancer
- What is being tested?
- urine collection and canine detection
- How many people
- 183 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2022to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Adult male with a positive biopsy (Gleason score greater than or equal to 7)
Who may be able to join
None listed.
Who cannot join
- 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"
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contribution of Canine Detection in the Diagnostic Strategy of High-risk Prostate Cancer
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?
Read the detailed description
"The purpose of this study is to validate the diagnostic aid performance of canine detection of high-risk prostate cancers (Gleason score 7 or more) by comparing it to prostate MRI with respect to the results of biopsies of the prostate, then to integrate this test into the current diagnostic strategy for prostate cancer.
We will carry out a descriptive observational prospective case-control study at the Bichat-Claude Bernard and Henri Mondor hospitals (France) in routine care in adult patients suspected of prostate cancer and having an indication for the realization of a urine sample, an MRI prostate cancer and prostate biopsies.
The patient journey will be as follows :
During the initial visit (V1), patients suspected of prostate cancer (pathological digital rectal examination, PSA > 4) are informed about the study. They can entrust their non-objection to participate in the study now, or return during a new visit (V2) after a reflection period of 2 to 6 weeks.
Each patient completed a clinical information questionnaire. A 60 ml urine sample is taken, part of which is used to perform the ECBU necessary for performing prostate biopsies. The remainder of the sample is used for research.
The next visit (V3) is that of performing prostate biopsies, which provide the diagnosis of certainty on the presence or absence of prostate cancer. In the meantime, the patient performed an MRI of the prostate. All of these interventions are part of the usual management of patients suspected of prostate cancer. This visit is followed by the comparison of the results of canine detection and prostate MRI with the results of prostate biopsies.
The last visit (V4) is a one-year follow-up visit. A new PSA assay and a digital rectal examination will be performed as part of the usual care.
The patients included in our study require a urine sample as part of their therapeutic management.
Part of this urine will be collected for our study, it will be frozen and then transported to the veterinary school of Maisons-Alfort.
Our research is divided into 2 phases:
- The validation phase, consisting of evaluating the diagnostic aid performance of canine olfaction for the diagnosis of prostate cancer in comparison to prostate MRI.
- The last phase of clinical interest, aimed at integrating canine olfaction into the current diagnostic strategy for prostate cancer, in particular in the case of negative MRI.
The sensitivity of canine olfactory detection will be calculated by dividing the number of patients marked by dogs among the patients diagnosed with high-risk prostate cancer from the biopsy.
The sensitivity of detection by MRI will be calculated by dividing the number of patients for whom the MRI indicated the presence of high-risk prostate cancer among the patients diagnosed with high-risk prostate cancer from the biopsy.
The 95% confidence intervals will be calculated using Jeffrey's method. The two calculated sensitivities will be compared using McNemar's statistical test.
The specificity of canine olfactory detection will be calculated by dividing the number of patients not marked by dogs among the patients who did not have high-risk prostate cancers diagnosed from the biopsy.
The specificity of detection by MRI will be calculated by dividing the number of patients for whom the MRI did not indicate the presence of high-risk prostate cancer among the patients whose biopsy did not indicate the presence of high-risk prostate.
The 95% confidence intervals will be calculated using Jeffrey's method. The two calculated specificities will be compared using McNemar's statistical test.
The concordance assessment scale quantified by Kappa from Landis and Koch will be used to assess the degree of concordance between the two methods (MRI, canine detection) and the biopsy.
This study will:
- Assess the diagnostic capacity of canine detection of prostate cancer in the event of a negative MRI.
- To validate a diagnostic score for prostate cancer including canine detection.
- Identify effluvia in the urine characteristic of prostate cancer.
- Assess the link between the PSA blood level and the concentration of volatile organic compounds in the urine.
- Evaluate the influence of subjects' lifestyle on the diagnostic capacity of canine detection of prostate cancer.
- Evaluate the influence of the grade of severity of prostate cancer on the diagnostic capacity of prostate cancer of canine detection.
The study respects the measures put in place to deal with the COVID-19 epidemic."
- Conditions
- High-risk Prostate Cancer
- Being tested
- urine collection, canine detection
- Keywords
- prostate cancer, canine detection, the dog's sense of smell
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine collectionOther
urine collection as part of the care and usual follow-up in the context of suspected prostate cancer
canine detectionOther
urine sample will be placed in a detection cone to be sniffed by 6 trained dogs
| Study group | Role | What they receive |
|---|---|---|
| case group | The case group is composed of Adult male with a positive biopsy (Gleason score greater than or equal to 7) Receives: 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. Receives: Other: urine collection; Other: canine detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
"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.
Measured: 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.
Measured: 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).
Measured: 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.
Each outcome measures will be transformed into a binary measurement in order to be able to create a diagnostic score. A PSA level greater than 4ng/mL is worth 1, while if it is less than 4ng/mL, the value 0 will be attributed to the patient. The presence of a nodule on the digital rectal examination is worth 1, while the absence of a nodule is worth 0. The presence of a target zone on the MRI is worth 1 while the absence of a target zone is worth 0. Marking by the dogs is worth 1 while non-marking is worth 0. The score therefore varies between 0 and 3 without the intervention of the dog and between 0 and 4 by integrating the dog. We will then compare the sensitivities and specificities obtained with these two scores to that of the biopsy, the objective being to determine whether the dog has an interest in the current diagnostic protocol.
Measured: 24 months
Perform a mass spectrometry examination on samples from the "case" group
The objective is to determine which volatile organic compounds are present in the urine, allowing the dogs to differentiate the urine of a healthy patient from the urine of a patient suffering from prostate cancer. We will analyze the urine of some patients with prostate cancer using a mass spectrophotometer.
Measured: 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."
Measured: 24 months
"Compare the performance of canine detection of prostate cancer (Se and Sp) with detection performance of prostate cancer by measuring the blood PSA level."
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start2 Nov 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk Prostate CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hermieu Jean-François, Surgeon, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558735
- Sponsor's protocol ID
- APHP220569
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Canine Detection in the Diagnostic Strategy of High-risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT05558735
- Acronym / sponsor ID
- APHP220569
- Conditions
- High-risk Prostate Cancer
- Keywords
- prostate cancer, canine detection, the dog's sense of smell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
"The purpose of this study is to validate the diagnostic aid performance of canine detection of high-risk prostate cancers (Gleason score 7 or more) by comparing it to prostate MRI with respect to the results of biopsies of the prostate, then to integrate this test into the current diagnostic strategy for prostate cancer.
We will carry out a descriptive observational prospective case-control study at the Bichat-Claude Bernard and Henri Mondor hospitals (France) in routine care in adult patients suspected of prostate cancer and having an indication for the realization of a urine sample, an MRI prostate cancer and prostate biopsies.
The patient journey will be as follows :
During the initial visit (V1), patients suspected of prostate cancer (pathological digital rectal examination, PSA > 4) are informed about the study. They can entrust their non-objection to participate in the study now, or return during a new visit (V2) after a reflection period of 2 to 6 weeks.
Each patient completed a clinical information questionnaire. A 60 ml urine sample is taken, part of which is used to perform the ECBU necessary for performing prostate biopsies. The remainder of the sample is used for research.
The next visit (V3) is that of performing prostate biopsies, which provide the diagnosis of certainty on the presence or absence of prostate cancer. In the meantime, the patient performed an MRI of the prostate. All of these interventions are part of the usual management of patients suspected of prostate cancer. This visit is followed by the comparison of the results of canine detection and prostate MRI with the results of prostate biopsies.
The last visit (V4) is a one-year follow-up visit. A new PSA assay and a digital rectal examination will be performed as part of the usual care.
The patients included in our study require a urine sample as part of their therapeutic management.
Part of this urine will be collected for our study, it will be frozen and then transported to the veterinary school of Maisons-Alfort.
Our research is divided into 2 phases:
- The validation phase, consisting of evaluating the diagnostic aid performance of canine olfaction for the diagnosis of prostate cancer in comparison to prostate MRI.
- The last phase of clinical interest, aimed at integrating canine olfaction into the current diagnostic strategy for prostate cancer, in particular in the case of negative MRI.
The sensitivity of canine olfactory detection will be calculated by dividing the number of patients marked by dogs among the patients diagnosed with high-risk prostate cancer from the biopsy.
The sensitivity of detection by MRI will be calculated by dividing the number of patients for whom the MRI indicated the presence of high-risk prostate cancer among the patients diagnosed with high-risk prostate cancer from the biopsy.
The 95% confidence intervals will be calculated using Jeffrey's method. The two calculated sensitivities will be compared using McNemar's statistical test.
The specificity of canine olfactory detection will be calculated by dividing the number of patients not marked by dogs among the patients who did not have high-risk prostate cancers diagnosed from the biopsy.
The specificity of detection by MRI will be calculated by dividing the number of patients for whom the MRI did not indicate the presence of high-risk prostate cancer among the patients whose biopsy did not indicate the presence of high-risk prostate.
The 95% confidence intervals will be calculated using Jeffrey's method. The two calculated specificities will be compared using McNemar's statistical test.
The concordance assessment scale quantified by Kappa from Landis and Koch will be used to assess the degree of concordance between the two methods (MRI, canine detection) and the biopsy.
This study will:
- Assess the diagnostic capacity of canine detection of prostate cancer in the event of a negative MRI.
- To validate a diagnostic score for prostate cancer including canine detection.
- Identify effluvia in the urine characteristic of prostate cancer.
- Assess the link between the PSA blood level and the concentration of volatile organic compounds in the urine.
- Evaluate the influence of subjects' lifestyle on the diagnostic capacity of canine detection of prostate cancer.
- Evaluate the influence of the grade of severity of prostate cancer on the diagnostic capacity of prostate cancer of canine detection.
The study respects the measures put in place to deal with the COVID-19 epidemic."
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | Other: urine collection, Other: canine detectionThe case group is composed of Adult male with a positive biopsy (Gleason score greater than or equal to 7) |
| control group | – | Other: urine collection, Other: canine detectionThe control group is made up of adult men performing a biopsy whose Gleason score is less than or equal to 6. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male with a positive biopsy (Gleason score greater than or equal to 7)
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urine collectionurine collection as part of the care and usual follow-up in the context of suspected prostate cancer | Other | case group, control group |
| canine detectionurine sample will be placed in a detection cone to be sniffed by 6 trained dogs | Other | case group, control group |
Primary outcome
"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. "
Time frame: 24 months
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.
6 secondary outcomes
Calculate the Kappa coefficient quantifying the concordance between canine detection and biopsy, first among patients with negative MRI then among patients with positive MRI.
Time frame: 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).
Time frame: 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.
Time frame: 24 months
Perform a mass spectrometry examination on samples from the "case" group
Time frame: 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."
Time frame: 24 months
"Compare the performance of canine detection of prostate cancer (Se and Sp) with detection performance of prostate cancer by measuring the blood PSA level."
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for High-risk Prostate Cancer
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingPhase 1
Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)
Prostate Cancer, Prostate Adenocarcinoma
Not yet recruitingPhase 4
Analysis of the Performance of PSMA Emission Tomography in Patients With Prostate Cancer Treated With HIFU
Prostate Cancer - Recurrent, Prostate Cancer (Diagnosis)
RecruitingPhase 2
A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.
High-risk Localized Prostate Cancer
Active, not recruitingPhase 2
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer
Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hermieu Jean-François, Surgeon principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High-risk Prostate Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"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. " (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.