Measurements of Sexual Steroids' Concentrations in Prostatic Tissue

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Hopital Foch

Suresnes, 92150, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Intra-prostatic concentrations of sex steroids

Time frame: Day 0

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.

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Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: Pré-HORM

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Feb 5, 2020
Registry last updated: Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed