Measurements of Sexual Steroids' Concentrations in Prostatic Tissue

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04256161

Acronym

Pré-HORM

Enrollment

Registered

2020-02-05

Start date

2020-06-26

Completion date

2021-07-07

Last updated

2021-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

Steroids' concentrations, Biopsy needle, Cystoprostatectomy

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Intra-prostatic concentrations of sex steroids	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.

Countries

France

Outcome results