Back to resultsCastration-resistant Prostate Cancer and Intra-prostatic Hormonal Status (HORM)
Primary Purpose
Prostate Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
intra-prostatic concentration of sexual steroids
Trans-rectal biopsy
Sponsored by
About this trial
This is an interventional other trial for Prostate Cancer
Eligibility 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
Sites / Locations
- Hopital Foch
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
prostate cancer patients resistant to castration
patients naif of hormonal treatment
Arm Description
Outcomes
Primary Outcome Measures
intra-prostatic concentration of sexual steroids
Secondary Outcome Measures
Androgen receptor immuno-histochemical expression level
Androgen receptor RNA expression level
Steroid 5-alphareductase immuno-histochemical expression level
Steroid 5-alphareductase RNA expression level
Steroid aromatase immuno-histochemical expression level
Steroid aromatase RNA expression level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03014973
Brief Title
Castration-resistant Prostate Cancer and Intra-prostatic Hormonal Status
Acronym
HORM
Official Title
Castration-resistant Prostate Cancer and Intra-prostatic Hormonal Status
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Study Start Date
January 2017 (Anticipated)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
prostate cancer patients resistant to castration
Arm Type
Experimental
Arm Title
patients naif of hormonal treatment
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
intra-prostatic concentration of sexual steroids
Intervention Type
Procedure
Intervention Name(s)
Trans-rectal biopsy
Primary Outcome Measure Information:
Title
intra-prostatic concentration of sexual steroids
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Androgen receptor immuno-histochemical expression level
Time Frame
2 weeks
Title
Androgen receptor RNA expression level
Time Frame
2 weeks
Title
Steroid 5-alphareductase immuno-histochemical expression level
Time Frame
2 weeks
Title
Steroid 5-alphareductase RNA expression level
Time Frame
2 weeks
Title
Steroid aromatase immuno-histochemical expression level
Time Frame
2 weeks
Title
Steroid aromatase RNA expression level
Time Frame
2 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yann NEUZILLET, MD
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henry Botto, MD
Organizational Affiliation
Hopital Foch
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Castration-resistant Prostate Cancer and Intra-prostatic Hormonal Status
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