Skip to content

Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02778243
Acronym
STERPROSER
Enrollment
107
Registered
2016-05-19
Start date
2014-09-30
Completion date
2016-11-12
Last updated
2017-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Hyperplasia, Urinary Bladder Neoplasms

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

Interventions

BIOLOGICALsteroids concentrations determination

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Serum concentrations of sexual steroids and intra-tissue on healthy prostates30 minutesA bio-informatical analysis will be performed to compare steroids concentrations profiles in both arms.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026