Finding studies
Finding studies
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Lead
Assistance Publique - Hôpitaux de Paris
"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."
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
