Measurements of Sexual Steroids' Concentrations in Prostatic Tissue

Bladder Cancer Clinical Trial

— Pré-HORM  

Official title:

Measurements of Sexual Steroids' Concentrations in Prostatic Tissue From Samples Taken by Biopsy Needle on Fresh Operating Parts : Measurements' Reliability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04256161
• Other study ID #: 2018_0049
• Status: Completed
• Start date: June 26, 2020
• Est. completion date: July 7, 2021

Study information

• Verified date: August 2021
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In the investigators's previous work, measurements of intra-prostatic concentrations of sex steroids were determined on samples taken from the operating room using a punch. In order to study the in-vivo intra-prostatic concentrations of sex steroid, it is necessary to validate a measurement technique performed on samples obtained by a biopsy needle used in standard care for prostate biopsy punctures allowing the diagnosis and follow-up of prostate cancer. The aim of this project is to validate this measurement technique carried out on samples obtained by the biopsy needle and to define the optimal number of carrots obtained by biopsy offering dosage results comparable to the punch.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 7, 2021
• Est. primary completion date: July 7, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient aged = 18 years
• With a bladder cancer
• Should be operated by total cystoprostatectomy at Foch Hospital
• Affiliated to a health insurance scheme
• Having expressed the non-opposition for the participation to the study

Exclusion Criteria:

• Patient receiving or has received a treatment by analog or antagonist of Luteinizing Hormone Releasing Hormone (LHRH), antiandrogens (steroidal or non-steroidal), 5 alpha-reductase inhibitor, docetaxel or cabazitaxel chemotherapy, abiraterone acetate, enzalutamide or corticosteroids
• Patient who does not understand French
• Patient deprived of liberty or under guardianship

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-prostatic concentrations of sex steroids	To compare intra-prostatic concentrations of sex steroids on samples taken by punch (reference technique) and by an increasing number (1 to 3 carrots) of samples taken by biopsy needle (experimental technique) on fresh surgical specimen.	Day 0