Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level

NCT02778243 | Completed

• 2 other identifiers: 2014/012014-A00706-41
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Bladder Neoplasms; Prostate Hyperplasia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Bladder cancer

EXPERIMENTAL

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

Biological: steroids concentrations determination

benign prostate hyperplasia

OTHER

▪ Patients with benign prostate hyperplasia who justified a prostatectomy.

Biological: steroids concentrations determination

Interventions

steroids concentrations determination BIOLOGICAL

Bladder cancer; benign prostate hyperplasia

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

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

Study Officials

• Henry Botto, PhD

  Urologie Hopital Foch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 19, 2016
• Study Start: September 1, 2014
• Primary Completion: November 12, 2016
• Study Completion: November 12, 2016
• Last Updated: June 14, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)