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

Primary Purpose

Urinary Bladder Neoplasms, Prostate Hyperplasia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
steroids concentrations determination
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Bladder Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Hopital Foch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Bladder cancer

benign prostate hyperplasia

Arm Description

▪ Patients justifying prostatectomy together with the bladder (radical cystectomy for bladder cancer).

▪ Patients with benign prostate hyperplasia who justified a prostatectomy.

Outcomes

Primary Outcome Measures

Serum concentrations of sexual steroids and intra-tissue on healthy prostates
A bio-informatical analysis will be performed to compare steroids concentrations profiles in both arms.

Secondary Outcome Measures

Full Information

First Posted
May 12, 2016
Last Updated
June 13, 2017
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT02778243
Brief Title
Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level
Acronym
STERPROSER
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
November 12, 2016 (Actual)
Study Completion Date
November 12, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasms, Prostate Hyperplasia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bladder cancer
Arm Type
Experimental
Arm Description
▪ Patients justifying prostatectomy together with the bladder (radical cystectomy for bladder cancer).
Arm Title
benign prostate hyperplasia
Arm Type
Other
Arm Description
▪ Patients with benign prostate hyperplasia who justified a prostatectomy.
Intervention Type
Biological
Intervention Name(s)
steroids concentrations determination
Primary Outcome Measure Information:
Title
Serum concentrations of sexual steroids and intra-tissue on healthy prostates
Description
A bio-informatical analysis will be performed to compare steroids concentrations profiles in both arms.
Time Frame
30 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Botto, PhD
Organizational Affiliation
Urologie Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level

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