Castration-resistant Prostate Cancer and Intra-prostatic Hormonal Status

Not Applicable

Withdrawn

• Conditions: Prostate Cancer
• Interventions: Biological: intra-prostatic concentration of sexual steroids; Procedure: Trans-rectal biopsy

• Registration Number: NCT03014973
• Lead Sponsor: Hopital Foch

Brief Summary

The main objective of the study is to determine the intra-prostatic concentration of sexual steroids when castration resistance appears in castration-resistant prostate cancer patients compared to patients naif of hormonal treatment

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-30
• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-09
• Primary Completion: 2018-06
• Last Update Submitted: 2018-09-12
• Last Update Posted: 2018-09-13
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• group 1: patients with a locally advanced prostate cancer naif of any hormonal treatment
• group 2: Patients with a castration-resistant prostate cancer resisting defined by a biological progression
• group 2a: without radiotherapy
• group 2b: with radiotherapy
• Affiliated to a social security scheme
• Having given a written consent.

Read More

Exclusion Criteria

• Patient unable to supply a written consent (patient not understanding French, under guardianship patient).
• neuro-endocrine form or sarcomatoid form prostate cancer

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prostate cancer patients resistant to castration	intra-prostatic concentration of sexual steroids	-
patients naif of hormonal treatment	intra-prostatic concentration of sexual steroids	-
prostate cancer patients resistant to castration	Trans-rectal biopsy	-
patients naif of hormonal treatment	Trans-rectal biopsy	-

Primary Outcome Measures

Name	Time	Method
intra-prostatic concentration of sexual steroids	2 weeks

Secondary Outcome Measures

Name	Time	Method
Steroid 5-alphareductase RNA expression level	2 weeks
Androgen receptor immuno-histochemical expression level	2 weeks
Androgen receptor RNA expression level	2 weeks
Steroid 5-alphareductase immuno-histochemical expression level	2 weeks
Steroid aromatase immuno-histochemical expression level	2 weeks
Steroid aromatase RNA expression level	2 weeks

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, France