Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level

Urinary Bladder Neoplasms Clinical Trial

— STERPROSER  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02778243
• Other study ID #: 2014/01
• Secondary ID: 2014-A00706-41
• Status: Completed
• Phase: N/A
• First received: May 12, 2016
• Last updated: June 13, 2017
• Start date: September 2014
• Est. completion date: November 12, 2016

Study information

• Verified date: November 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: November 12, 2016
• Est. primary completion date: November 12, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hyperplasia
• Prostate Hyperplasia
• Prostatic Hyperplasia
• Urinary Bladder Neoplasms

Intervention

Biological:
• steroids concentrations determination

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 minutes