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

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ClinicalTrials.gov Identifier: NCT02778243
Recruitment Status : Completed
First Posted : May 19, 2016
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Study Description
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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.


Condition or disease Intervention/treatment Phase
Urinary Bladder Neoplasms Prostate Hyperplasia Biological: steroids concentrations determination Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Actual Study Start Date : September 2014
Actual Primary Completion Date : November 12, 2016
Actual Study Completion Date : November 12, 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Bladder cancer
▪ Patients justifying prostatectomy together with the bladder (radical cystectomy for bladder cancer).
 Biological: steroids concentrations determination
benign prostate hyperplasia
▪ Patients with benign prostate hyperplasia who justified a prostatectomy.
 Biological: steroids concentrations determination


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02778243


Locations
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France
Hopital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
Investigators
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Principal Investigator: Henry Botto, PhD Urologie Hopital Foch
More Information
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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT02778243    
Other Study ID Numbers: 2014/01
2014-A00706-41 ( Other Identifier: ANSM )
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Urologic Neoplasms
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Prostatic Diseases