Castration-resistant Prostate Cancer and Intra-prostatic Hormonal Status (HORM)

September 12, 2018 updated by: Hopital Foch
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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France, 92150
        • Hopital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: prostate cancer patients resistant to castration
Biological: intra-prostatic concentration of sexual steroids
Procedure: Trans-rectal biopsy
Experimental: patients naif of hormonal treatment
Biological: intra-prostatic concentration of sexual steroids
Procedure: Trans-rectal biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intra-prostatic concentration of sexual steroids
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Androgen receptor immuno-histochemical expression level
Time Frame: 2 weeks
2 weeks
Androgen receptor RNA expression level
Time Frame: 2 weeks
2 weeks
Steroid 5-alphareductase immuno-histochemical expression level
Time Frame: 2 weeks
2 weeks
Steroid 5-alphareductase RNA expression level
Time Frame: 2 weeks
2 weeks
Steroid aromatase immuno-histochemical expression level
Time Frame: 2 weeks
2 weeks
Steroid aromatase RNA expression level
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Yann NEUZILLET, MD, Hopital Foch
  • Study Chair: Henry Botto, MD, Hopital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2017

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

December 30, 2016

First Submitted That Met QC Criteria

January 5, 2017

First Posted (Estimate)

January 9, 2017

Study Record Updates

Last Update Posted (Actual)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/03
  • 2016-A00020-51 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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