Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level (STERPROSER)

June 13, 2017 updated by: Hopital Foch

Patients followed in the Foch Hospital Urology Department (Suresnes): Patients justifying a prostatectomy.

  • Patients justifying prostatectomy together with the bladder (radical cystectomy for bladder cancer).
  • Patients with benign prostate hyperplasia who justified a prostatectomy. Compare serum sexual steroid concentrations and intra-tissue on healthy prostates and prostate adenoma, assess concentrations intra-tissue sex steroids on cancer metastasis prostate specific blood sample under study (30mL) will be performed preoperatively in Patients followed in Foch Hospital Urology Department (Suresnes), and a Removal of a fragment of prostate tissue or metastasis will be analyze.

Aim is to compare serum concentrations of sexual steroids and intra-tissue on healthy prostates and prostate adenomas compared to concentrations measured in patients operated for prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Steroids concentration will be determined using Gas chromatography-mass spectrometry. The analyzed steroids are :

FSH :Mul/ml LH: mUI/ml SHBG: µg/ml BT: ng/ml TT: ng/ml DHT: ng/ml DHEA: ng/ml D5: ng/ml D4: ng/ml E1: pg/ml E2 : pg/ml DHEA-S : µg/dl

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France, 92150
        • Hôpital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men aged over 18 years
  • Surgical indication justifying protatique prostatectomy, or complete prostatocystectomie, or removal of a metastasis of prostate cancer.
  • Patients affiliated to a social security scheme or benefiting from such a regime.
  • Patients who have given their consent to participate in writing

Exclusion Criteria:

  • Patient received local therapy or hormonal treatment (LHRH analogue, therapy blocking androgen receptors) before surgery.
  • Treatment reductase inhibitors 5ARI ongoing or stopped for less than 3 months before the intervention.
  • Patient included in another clinical trial inconsistent with the conduct of this research.
  • Patient receiving treatment that could interfere with hormone levels (Prednisone, Ketoconazole, Abiraterone, Finasteride, Dutasteride).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bladder cancer
▪ Patients justifying prostatectomy together with the bladder (radical cystectomy for bladder cancer).
Biological: steroids concentrations determination
Other: benign prostate hyperplasia
▪ Patients with benign prostate hyperplasia who justified a prostatectomy.
Biological: steroids concentrations determination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum concentrations of sexual steroids and intra-tissue on healthy prostates
Time Frame: 30 minutes
A bio-informatical analysis will be performed to compare steroids concentrations profiles in both arms.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Henry Botto, PhD, Urologie Hopital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

November 12, 2016

Study Completion (Actual)

November 12, 2016

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

May 17, 2016

First Posted (Estimate)

May 19, 2016

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/01
  • 2014-A00706-41 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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