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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03014973
Recruitment Status : Withdrawn
First Posted : January 9, 2017
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: intra-prostatic concentration of sexual steroids Procedure: Trans-rectal biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Castration-resistant Prostate Cancer and Intra-prostatic Hormonal Status
Estimated Study Start Date : January 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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



Primary Outcome Measures :
  1. intra-prostatic concentration of sexual steroids [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Androgen receptor immuno-histochemical expression level [ Time Frame: 2 weeks ]
  2. Androgen receptor RNA expression level [ Time Frame: 2 weeks ]
  3. Steroid 5-alphareductase immuno-histochemical expression level [ Time Frame: 2 weeks ]
  4. Steroid 5-alphareductase RNA expression level [ Time Frame: 2 weeks ]
  5. Steroid aromatase immuno-histochemical expression level [ Time Frame: 2 weeks ]
  6. Steroid aromatase RNA expression level [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014973


Locations
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France
Hopital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
Investigators
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Principal Investigator: Yann NEUZILLET, MD Hopital Foch
Study Chair: Henry Botto, MD Hopital Foch
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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT03014973    
Other Study ID Numbers: 2016/03
2016-A00020-51 ( Other Identifier: ANSM )
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases