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20G.196

Detection of prostate cancer using voided urine
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT04788277
Recrutement ouvert
Dernière modification : 2024/06/26
Type de recherche

Observationnel


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Sexe(s) des participants

MALE

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

Inclusion Criteria:

* Provide signed and dated informed consent form
* Male
* Patients must be 50-70 years of age
* Willing to comply with all study procedures
* Prior to digital rectal exam (DRE)
* Patients with the diagnosis of prostate cancer (Cohort 1 N=150)

* Prior to radical prostatectomy/radiotherapy (XRT) or systemic therapy
* May be on active surveillance
* Patients with elevated PSA level but no know prostate cancer (Cohort 2 N=150)

* Diagnosis of BPH/lower urinary tract symptoms (LUTS)
* No prior diagnosis of prostate cancer
* Prior negative biopsy with PSA \> 1.5
* Without biopsy PSA \< 1.5
* Patients with normal PSA levels (Cohort 3 N=200)

* No documented history of BPH (no medical management or prior surgical treatment for BPH)
* PSA \< 1.5
* No documented history of prostate cancer
* No documented history of urothelial carcinoma
* Patients Pre DRE and Post DRE (Cohort 4 N=200)\*\*
* Patients on with a known Gleason Score (Cohort 5= 150)

Exclusion Criteria:

• Patients under the age of 50

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
Nom Condition médicale Traitement État du recrutement
Diagnostic (biospecimen collection) Patients undergo collection of urine samples at baseline during standard of care office/clinic visit. Donnée non disponible
  • Inconnu
  • Diagnostic (biospecimen collection)
    État du recrutement
    unknown
    Données à jour depuis : 26 juin 2024

    Description de l'étude

    Résumé de l'étude

    This study collects urine from male patients seen at the urology clinic to detect prostate cancer cells, shed in voided urine, using the optical imaging method developed in the laboratory, which targets certain biomarkers expressed on prostate cancer cells. The information learned from this study may allow researchers develop a simple diagnostic test for the management of those patients who have elevated prostate specific antigen (PSA) and are suspected to have prostate cancer. It may also help researchers understand the genetic risk factors associated with prostate cancer.

    Source : Importé depuis le centre

    PRIMARY OBJECTIVE:

    I. To detect prostate cancer cells, shed in voided urine, using the optical imaging method developed in our laboratory, which targets vasoactive intestinal polypeptide receptor 1 (VPAC1) receptors expressed on prostate cancer cells and validates the results with prevailing condition of the patients/volunteers and evaluate diagnostic accuracy.

    SECONDARY OBJECTIVES:

    I. To establish if the malignant cells as a percent of total cell shed in the urine.

    II. To establish the fluorescence intensity around malignant cells. III. To establish if the VPAC protein quantity in shed malignant cells correlate with the aggressiveness of the disease.

    OUTLINE:

    Patients undergo collection of urine samples at baseline during standard of care office/clinic visit.

    Source : Importé depuis le centre

    Sites

    Centres participants


    Dernière modification : 26 juin 2024
    Données à jour depuis : 28 juin
    Origine des données : clinicaltrials.gov
    Référence clinicaltrials.gov: NCT04788277