Castration-resistant Prostate Cancer and Intra-prostatic Hormonal Status

NCT ID: NCT03014973

Last Updated: 2018-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-12-31

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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prostate cancer patients resistant to castration

Group Type EXPERIMENTAL

intra-prostatic concentration of sexual steroids

Intervention Type BIOLOGICAL

Trans-rectal biopsy

Intervention Type PROCEDURE

patients naif of hormonal treatment

Group Type EXPERIMENTAL

intra-prostatic concentration of sexual steroids

Intervention Type BIOLOGICAL

Trans-rectal biopsy

Intervention Type PROCEDURE

Interventions

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intra-prostatic concentration of sexual steroids

Intervention Type BIOLOGICAL

Trans-rectal biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Exclusion Criteria

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

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yann NEUZILLET, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Foch

Henry Botto, MD

Role: STUDY_CHAIR

Hopital Foch

Locations

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Hopital Foch

Suresnes, , France

Site Status

Countries

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France

Other Identifiers

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2016-A00020-51

Identifier Type: OTHER

Identifier Source: secondary_id

2016/03

Identifier Type: -

Identifier Source: org_study_id

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