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Completed

NCT Number: NCT02778243

Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level

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.

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Key information

Conditions

Urinary Bladder Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Hyperplasia Prostatic Diseases Prostatic Hyperplasia Urinary Bladder Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Foch

Suresnes, 92150, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

steroids concentrations determination

Biological

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: STERPROSER

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 19, 2016
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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