Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level

Not Applicable

Completed

• Conditions: Urinary Bladder Neoplasms; Prostate Hyperplasia
• Interventions: Biological: steroids concentrations determination

• Registration Number: NCT02778243
• Lead Sponsor: Hopital Foch

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

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-19
• Status Verified: 2016-11
• Primary Completion: 2016-11-12
• Study Completion: 2016-11-12
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 107

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bladder cancer	steroids concentrations determination	▪ Patients justifying prostatectomy together with the bladder (radical cystectomy for bladder cancer).
benign prostate hyperplasia	steroids concentrations determination	▪ Patients with benign prostate hyperplasia who justified a prostatectomy.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, France