Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level

NCT ID: NCT02778243

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-11-12

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

Conditions

Urinary Bladder Neoplasms; Prostate Hyperplasia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Bladder cancer

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

Group Type: EXPERIMENTAL

steroids concentrations determination

Intervention Type: BIOLOGICAL

benign prostate hyperplasia

▪ Patients with benign prostate hyperplasia who justified a prostatectomy.

Group Type: OTHER

steroids concentrations determination

Intervention Type: BIOLOGICAL

Interventions

steroids concentrations determination

Intervention Type: BIOLOGICAL

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henry Botto, PhD

Role: PRINCIPAL_INVESTIGATOR

Urologie Hopital Foch

Locations

Hopital Foch

Suresnes, , France

Countries

France

Other Identifiers

2014-A00706-41

Identifier Type: OTHER

Identifier Source: secondary_id

2014/01

Identifier Type: -

Identifier Source: org_study_id