Measurements of Sexual Steroids' Concentrations in Prostatic Tissue

NCT04256161 | Completed

• 1 other identifier: 2018_0049
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

Steroids' concentrations; Biopsy needle; Cystoprostatectomy

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male with a bladder cancer and expected to benefit from a total cystoctoectomy in the Urology Department of Foch Hospital.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

1 sample of prostate tissue obtained by punch (90 mg) 6 samples of prostate tissue obtained by biopsy needle (3 mg by sample)

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Yann NEUZILLET, PhD

  Hopital Foch, Suresnes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 5, 2020
• Study Start: June 26, 2020
• Primary Completion: July 7, 2021
• Study Completion: July 7, 2021
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)